Clinical Trial Associate Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the clinical trial associate job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

S Harvey

Salvatore

Harvey

26481 Leonor Pass

Boston

+1 (555) 693 7692

26481 Leonor Pass

Boston

Phone

p +1 (555) 693 7692

Experience Experience

Chicago, IL

Clinical Trial Associate

Chicago, IL

Cummerata and Sons

Chicago, IL

Clinical Trial Associate

Ensure work is performed in accordance with industry standards, federal and state regulations, accreditation standards and Berg Pharma mission and core values
Supports and/or tracks external access rights to Clinical Trial Management Systems
Assist with documents during study start-up including CDAs and CTAs
Assist with compilation of regulatory documents
Perform essential support for clinical research throughout all stages of a project
Assist the CS in organizing investigator/site initiation meetings and/or first dose/monitoring visits
Performs data entry into the CTMS system for study or client information

Houston, TX

Clinical Trial Associate, Outsourcing

Houston, TX

Zieme LLC

Houston, TX

Clinical Trial Associate, Outsourcing

Work cross functionally on reporting enhancements and process improvements
Works collaboratively with clinical team on month end reconciliation
Financial contract review support and in gathering month end financial reporting from CROs/Vendors
Supports ClinOut& Fin Sr. CTA, Director, and Clinical Ops CTMs in month end clinical project accrual reporting and reforecasting efforts in support of the clinical projects
Supports ClinOut& Fin Sr. CTA with collection of financial documentation supporting contract milestones, Sarbanes-Oxley compliance, accruals and monthly financial reconciliation
Provide operational input on development, management and maintenance of study plans and tools
Defines TMF issues and works with manager to resolve problems

present

Detroit, MI

Senior Clinical Trial Associate

Detroit, MI

Rolfson Group

present

Detroit, MI

Senior Clinical Trial Associate

present

Participate in process improvement and development: SOP development, training, process mapping, and other departmental activities
Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
Participate in inter-departmental workgroups to create or enhance processes
Participate in vendor specification development and management/oversight
Develop and maintain a good working knowledge of relevant protocols
Contribute to general departmental administration and the development and continuous improvement of departmental procedures
Take on career developmental activities/tasks as necessary

Education Education

Bachelor’s Degree in Clinical

Michigan State University

Bachelor’s Degree in Clinical

Skills Skills

Attention to detail, solid execution, strong interpersonal skills, and a team player
Computer Literature: Good Knowledge at user level of Microsoft Office. Proficiency in Microsoft applications
Comfortable with technolgy and ability to learn new systems quickly
Excellent organisational skills and good attention to detail
Good interpersonal skills, ability to successfully interact with a wide range of people
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
Strong attention to detail
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Strong knowledge of MS Word, Excel, PowerPoint and Outlook

Create a Resume in Minutes

15 Clinical Trial Associate resume templates

Read our complete resume writing guides

Senior Clinical Trial Associate Resume Examples & Samples

35% - Study Start Up
Facilitate CDA & Contract Execution Process (Routing and
Manage related task specific study vendor
Create &/or present study or task related information to CRO/Investigators
Under supervision of study manager or clinical lead, may assist with tasks typically associated with study management such as site visits, clinical document/ report review, ICD
Take on mentor role for existing & new CTA team members
Take on career developmental activities/tasks as necessary
Associates/Bachelor's degree and/or equivalent relative experience required
Minimum 2-4 year's experience in supporting or managing tasks within clinical trials
Relevant experience in clinical research or related field
General knowledge of regulatory requirements and guidelines governing clinical research
Comfortable with technolgy and ability to learn new systems quickly
Strong knowledge of MS Word, Excel, PowerPoint and Outlook
Must be able to work in a fast paced environment with demonstrated ability to juggle
Ability to present clinal information in a professional forum

Clinical Trial Associate Resume Examples & Samples

20% - Study Maintenance
Support SUSAR distribution
Facilitate contract execution & study related PO creation for any change orders
15% - Study Close Out
Assist study team with preparation for audits/inspections
25% Departmental Tasks
Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, Sharepoint)
Maintain up to date training record attending internal/external training as necessary
Participate in inter-departmental workgroups to create or enhance processes
Associates/Bachelor's degree or relevant equivalent experience preferred
Minimum 0-2 year's experience in relevant field (eg. Clinical Site, CRO, Sponsor or Clincal trial Vendor)
Adequate Good Clinical Practice training
Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization
Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
Ability to work successfully within a cross-functional team
Understanding how their input and role coordinate more effective business practices for Shire’s Clinical Program’s business overall and committing to the culture, vision and mission of Shire

Senior Clinical Trial Associate Resume Examples & Samples

35%: Study Start Up
15%: Study Maintenance
25%: Departmental Tasks

Senior Clinical Trial Associate Resume Examples & Samples

Facilitate CDA & Contract Execution Process (Routing and tracking of study specific contracts)
Manage study specific PO Creation
Collaborate with Study Manager and CRO to ensure accurate study specific CTMS setup and data feeds
Liaise with Transparency group to ensure Clintrials.gov is updated accordingly
Participate in creation and distribution of sponsor specific study aides/materials and communications
Key point person for R&D select background checks
Collate documents required for the EC/IRB/HA submissions
15% - Study Maintenance
Assist Clinical Study Manager in tracking study related activities which are not appropriate to be outsourced
Agenda distribution & minute taking for internal study team meetings
Maintain internal & external contacts lists in CTMS
10% - Study Close Out
Assist study team in close out in CTMS
Liaise with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly
15% - Study Management Tasks (as necessary)
Under supervision of study manager or clinical lead, may assist with tasks typically associated with study management such as site visits, clinical document/ report review, ICD template generation and/or review, review IMP release packet prior to initiation, etc

Clinical Trial Associate Resume Examples & Samples

Bachelor's Degree in a Life Science
1-5 years relevant industry experience in quality, regulatory, compliance, clinical research, or drug development
Knowledge of global clinical trial transparency and data sharing requirements
Experience with data entry into clinical trial public websites

Senior Clinical Trial Associate Resume Examples & Samples

35%:Study Start Up
10%:Study Close Out
25%:Departmental Tasks
Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, SharePoint)

Clinical Trial Associate Resume Examples & Samples

40%: Study Start Up
20%: Study Maintenance
15%: Study Close Out

Clinical Trial Associate Resume Examples & Samples

Strong oral and written skills with proficiency in English
Analytical approach and anticipation of problems
Ability to multi-task effectively and prioritize assignments from multiple sources
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
Provide operational input on development, management and maintenance of study plans and tools
Monitoring visit report review
Informed Consent review
Support Health Authority inspections and CQA audits
Ensure full compliance (of the required data in study management tools)
Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
Manage Trial Master File set-up, ongoing quality review, and final reconciliation
Reconcile IP at study level in collaboration with IMSC
Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes
Contribute to development / coordination of study training for study team, investigational sites, and vendors
Manage vendor and site payment processing and tracking
May perform other assigned tasks as required

Clinical Trial Associate Resume Examples & Samples

Clinical study team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, tracking, and management of logistics in support of clinical trials
Works closely with CTM, Study Start Up and legal to review and approve clinical trial agreements and site specific study budgets
Supports and/or tracks external access rights to Clinical Trial Management Systems
In conjunction with clinical operations team, manages and tracks clinical and non-clinical supplies required for distribution during study start up
Supports tasks related to data management
Reviews clinical trial documentation including monitoring visit reports, study plans, communication plans, timelines, informed consent templates etc
Responsible for set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files. Coordinates TMF transfer with CROs
Works with CRO and Study Start Up to collect and review essential regulatory documents prior to site initiation/study drug release
Participates in user acceptance testing (UAT) for IWRS
Responsible for agendas and meeting minutes for clinical study team meetings
Assisting in the routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs), contracts and change orders with Associate Director Clinical Operations, legal, and finance departments.Responsible for facilitating site advertisement review and approval with CCC Committee
Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, Sunshine Act, systems implementation, training, etc
Bachelor’s degree or equivalent undergraduate degree
Experience: 3-5 years clinical research experience in a pharmaceutical/biotech, CRO setting
Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials

Clinical Trial Associate Resume Examples & Samples

Reconciliation for phase 1-3 active and legacy studies (i.e., inventory, reconciliation and resolution of any deficiencies)
Ensure TMF completeness and accuracy based on SOP's and Regulatory requirements
Defines TMF issues and works with manager to resolve problems
Experience with Good Documentation Practice and ICH/GCP compliance
Understanding of records management
Understanding of drug development and clinical operations
Can locate information quickly and resourcefully
Can manage assignments independently to meet timelines/milestones
Completes other tasks as delegated by team leader
Provides supervisor with feedback, input and perspective on TMFs
Able to work with little instruction on routine work
1-2 years experience from similar work within a pharmaceutical company or CRO is preferable, but can also have experience other relatable experience in a different industry

Clinical Trial Associate Resume Examples & Samples

You will need to ensure high levels of accuracy when completing tasks, you will set up, manage and maintain clinical study documentation and coordinate the ordering, dispatch and tracking of study materials. You will support the project teams by updating the Clinical Trial Management Systems
You will possess sufficient administrative experience within a busy environment where you have demonstrated excellent organisation and prioritization skills or hold a bachelor’s degree in a science related field. Your experience of prioritising a demanding workload and ability to produce work to tight deadlines will be essential for this role
You must possess previous working knowledge of Word, Excel, Outlook and PowerPoint

Senior Clinical Trial Associate Resume Examples & Samples

Provide operational input on development, management and maintenance of study deliverables
Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
Lead / Participate in monitoring visit report review process
Support Health Authority inspections and CQA audits as required
Ensure full compliance of the required data in study management tools
Proactive identification of potential risks and development/implementation of actions
Develop and maintain collaborative relationships with internal and external partners/stakeholders
Participate in vendor specification development and management/oversight
Manage TMF set-up, ongoing quality review, and final reconciliation
Reconcile IP at study level
Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes…)
Contribute to development / coordination of study training
Contribute to ordering and distribution of materials as required
Manage study-level IP shipment to sites
Manage collection, review and tracking of study documents as necessary
Assist with Investigator meeting coordination and planning
Assist with compilation of Clinical Study Report appendices
Assist with maintenance of study budget tracking tools and reconcile invoices
Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives
Degree in a relevant discipline with experience in the Clinical Trial environment (CRA plus in-house experience bonus)
Demonstrates analytical approach and anticipation of problems
Strong knowledge of MS applications
Knowledge of drug development process

Senior Clinical Trial Associate Resume Examples & Samples

Clinical project team member: works closely with the Clinical Program Manager and is responsible for oversight and execution of assigned clinical studies, timelines, and key deliverables
Clinical Study Team leader: Coordinates and participates in internal and external cross-functional clinical team meetings; serves as main point of contact study-level status updates
Provides oversight and mentorship to Clinical Trial Associate(s) assigned to trials
Participates in selection of CROs and vendors, RFP process, contract and budget negotiations
Responsible for developing, maintaining and tracking study budgets and financial reporting, including invoice and PO management/reconciliation, accrual tracking and reporting, and re-forecasting, with Finance and Project Management
Supports tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors

Senior Clinical Trial Associate Resume Examples & Samples

Identifies gaps and provides constructive feedback and solutions
Basic understanding of project management desired
Knowledge of study tools including electronic system skills such as CTMS / EDC

Clinical Trial Associate Resume Examples & Samples

To handle all study related administrative taks by utilizes technology effectively to support the clinical trial development processes with the use of Clinical Trial Management System at the Protocol, Country and Site level
Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial
Collaborate with the study project team to reach target within set timelines
Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study
Set up and maintenance of the Trial Master Files, Electronic filing systems/ set up of the Investigator Site File
Coordinating archiving of study documentation
Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites and re-ordering supplies
Preparing essential clinical trial documentation, distributing, tracking and filing of documents. on return
Understands basic financial analysis of a clinical trial budget and has the ability to track and manage study related contract and payments
Effectively uses available tools and systems to gather information needed to manage study activities and to provide feedback to the appropriate BMS team members
Identifies potential issues and suggests resolutions. Answers and resolves routine questions independently
University Degree or equivalent in health sciences, nursing or pharmacy or related field
At least 2-3 years of experience as CTA in Clinical Research or in the Pharmaceutical Industry
Knowledge of the Industry/Clinical trial process and drug development and of ICH GCP
Experienced in multitasking and prioritizing
Excellent organisational skills and good attention to detail
Ability to decision making, problem-solve, providing contingency plans
Able to work with flexibility and independently
Experienced with IT-technology as e.g. word-processing, presentation graphic, spreadsheet, database, and file management. (ARIBA, ECLIPSE, SAP)
Good verbal and written communication skills (both in Swedish and English)

Lead Clinical Trial Associate Resume Examples & Samples

Solid experience in pharma/CRO/healthcare
Solid knowledge of drug development process
Intermediate knowledge of ICH/GCP and local guidelines, regulations and directives
Offer suggestions and contributes to discussion regarding milestones and deliverables
Advanced computer technical skills
Working knowledge of budgets, finance and clinical trials

Clinical Trial Associate Resume Examples & Samples

Bachelor’s degree or equivalent from an accredited college or university is required; Life Sciences degree preferred
3+ years’ of health sciences experience is required (pharmaceutical industry or related experience is preferred; work in the areas of contracts, budgets, clinical operations, and/or project management a plus)
Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary
Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment
Proficiency using Microsoft Word, Excel and PowerPoint; Microsoft Project is a big plus
Understanding of finance principles and applies to managing project budgets
Excellent oral and written English communication skills
Ability to present financial and technical information in a concise and clear manner
Experience in various electronic data capture systems involving site enrollment and tracking is a plus

Clinical Trial Associate Resume Examples & Samples

Clinical project team member: works closely with the Associate Director, Study Start Up and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical study start up
Supports and tracks study start up status and metrics, for assigned clinical projects
Responsible for data entry into Clinical Trial Management Systems, including Investigator databases, and/or other systems as required
Interacts with CROs, vendors, clinical sites, monitors and other external partners to provide information and resolution for specific requests and issues
Assists with and/or responsible for agendas and meeting minutes for clinical start up meetings
Assists with logistics coordination for investigator meetings and external vendor meetings, as needed
Responsible for review of site- and/or country-specific clinical trial budgets, with supervision by Associate Director, Study Start Up and/or clinical project team
Research country-specific clinical trial laws and regulations, upon request, in order to provide resources or information to Associate Director Study Start up and/or clinical project team
Coordinate with clinical operations project team on set-up of Trial Master File systems
Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act etc
Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred
Experience: 1-2 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Adaptable to changing priorities, excels in fast-paced environment

Clinical Trial Associate Resume Examples & Samples

Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies
Prepare, collect and provide support to sites on essential document collection and maintenance
Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper)
Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File
Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions
Coordinate with Recruitment Management regarding advertising submissions to IRB
Prepare Drug Release Authorization forms and collect required documentation
Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF
Prepare materials (eg, binders, agendas, meeting minutes) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF)
Performs data entry into the CTMS system for study or client information
May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
Perform administrative tasks to support team members with clinical trial execution as needed
General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority
Strong Computer skills including proficiency in use of Microsoft Word,

Clinical Trial Associate Resume Examples & Samples

Assist in the successful and timely progress of all clinical operations
Assist in the development, implementation, and maintenance of Clinical Trial Master File, as needed
Ensure all drug and supply requests are promptly filled (if applicable)
Prepare patient trackers and meeting agendas as directed
Coordinate the scheduling of all trial-related conference calls
Assist the VP of Clinical Operations in the creation and maintenance of internal policies and SOPs as well as policies intended to assist researchers in maintaining compliance with research standards and guidelines
Ensure adherence to protocols and compliance with GCP, ICH, GMP, and regulatory guidelines
Participate in global research activities such as creating tools & training materials
Prepare reports, documents, statistical surveys and other such data, as required
Provide support to other individuals, as needed
Requires a BS degree in a scientific discipline with at least 2 years of clinical operations exposure in the pharmaceutical industry and/or CRO; or equivalent healthcare experience
Proven experience in a fast-paced biotechnology environment undertaking multiple early phase clinical trials is preferred
Requires basic knowledge of pharmaceutical and biologic clinical Phase I-III trials with a strong emphasis on early development trials
Effective communication with physicians, fellow employees, patients, guests, contractors and vendors
Excellent MS Office applications skills, especially well-versed in the use of Excel spreadsheets and PowerPoint
Attention to details; ability to maintain confidentiality and security
Experience and success working in a busy team environment under high pressure
Flexibility in a growing organization

Clinical Trial Associate Resume Examples & Samples

Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory
Take personal responsibility for the quality of work, meeting required quality and performance standards and
Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research
Advance in written and spoken English
Computer Literature: Good Knowledge at user level of Microsoft Office. Proficiency in Microsoft applications
1+ year experience as a clinical Trial Administrator or in a Clinical Research & Development

Intern, Clinical Trial Associate Resume Examples & Samples

Support initiatives including, assisting with newly implemented clinical trial electronic document storage system
Prepare electronic documents (external and internal) with appropriate file names
Upload documents into electronic document management system (Documentum, D2/eTMF)
Draft clinical trial correspondence for CRA to send to Investigators and clinical sites
Track the status of Monitoring reports from monitoring visit through final sign-off
Review Clinical Study Reports for compliance with applicable format and style guides
The successful candidate will have preferably completed a minimum of their sophomore year and be currently enrolled in an accredited college or university in a healthcare, scientific or psychology degree program, or a related field of study. A minimum 3.0 GPA is strongly preferred, however, a combination of experience and/or education will be taken into consideration
Knowledge of Good Clinical Practices (GCP) and clinical trial research preferred but not required
Must possess excellent computer skills to include MS Word, MS Excel, Adobe and familiarity with MS Access

Clinical Trial Associate, Outsourcing Resume Examples & Samples

Supports ClinOut& Fin Sr. CTA with collection of financial documentation supporting contract milestones, Sarbanes-Oxley compliance, accruals and monthly financial reconciliation
Supports ClinOut& Fin Sr. CTA, Director, and Clinical Ops CTMs in month end clinical project accrual reporting and reforecasting efforts in support of the clinical projects
Work cross functionally on reporting enhancements and process improvements
Support ad-hoc projects as required
Financial contract review support and in gathering month end financial reporting from CROs/Vendors
Works collaboratively with clinical team on month end reconciliation

Senior Clinical Trial Associate Resume Examples & Samples

Coordinate with internal and external resources to develop project-specific recruitment plans and manage the production of project-specific promotional materials
In conjunction with clinical project teams, support selection of and manage recruitment / retention vendors, and support the development of recruitment strategies, branding, and campaign concepts
Coordinate and support internal recruitment-specific meetings to identify trends, share lessons learned, and deploy process improvements or new strategies to ensure best in class recruitment / retention campaigns across Alkermes’ studies
Support the production of all advertising content
Work with internal, cross-functional team to ensure all materials (central and site-specific) are reviewed and approved by the required internal team, relevant functional areas and committees
Ensure all promotional materials are submitted, reviewed and approved by the appropriate ethics committees and health authorities
Facilitate changes to recruitment materials
Coordinate with CRO representatives to disseminate materials from central recruitment campaigns to clinical sites, and ensure the utilization of materials is in-line with expectations
Work with investigator site representatives, CROs, and other vendors to develop recruitment plans and to facilitate the creation and review of site-specific recruitment/retention materials
Track and report trends across sites, studies, and programs including but not limited to
Overall return on investment and campaign effectiveness
Enrollment metrics
Cost/budgetary forecasting and tracking
Vendor and site performance metrics
Ensure appropriate information on recruitment trends is available in the Investigator database, and / or other clinical tracking systems / databases
Support development of standard operating procedures (SOPs), training guides and other user reference material related to clinical recruitment and retention. Provide training to department staff and other team members involved in recruitment/retention strategies, including vendor partners, as needed
Other Clinical and Start-up Related Tasks
Maintains access rights to all required clinical systems, inclusive of e-TMF, Investigator Database, CTMS (Clinical Trial Management Systems), and any other systems, as needed
Attends appropriate clinical study team meetings, and reports on progress in promotional materials
Bachelor’s degree or equivalent undergraduate degree preferred
Experience: minimum 2 years relevant experience in a pharmaceutical/biotech, CRO, site and/or patient recruitment agency setting, with prior experience in the implementation of patient recruitment activities
Solid knowledge and understanding of GCP/ICH Guidelines

Clinical Trial Associate Resume Examples & Samples

Assist with documents during study start-up including CDAs and CTAs
Assist with compilation of regulatory documents
Track incoming and outgoing regulatory packages
Assist in organization of Investigators’ Meetings
Assist with patient tracking to document patient visits and overall study progress
File essential documents and maintain the TMF
Track CRFs
Coordinate investigator payments for studies where the Sponsor is responsible for this activity. Verify investigator payment details submitted for payment by CROs for studies where CROs are responsible for this activity
Support Clinical Project Manager / Associate Director with meetings, including preparation of agendas and minutes and tracking action items
Distribute trial-related materials to study sites
Support preparation and subsequent distribution of newsletters
Prepare Study File Notebook for review by study team
Create and maintain tracking tools to monitor collection and expiry of essential documents; work with CRO team to obtain required updates
Create and maintain the Trial Master File and electronic workspace (Sharepoint) for each study and the program. Ensure that all essential study documents are tracked and filed in a timely manner
Prepare, distribute, file, and archive clinical documentation and reports
Review study files/TMF periodically for accuracy and completeness
Review site regulatory and essential documents to approve initial drug shipment
Assist with essential document reconciliation at study end

Clinical Trial Associate Resume Examples & Samples

Assist Clinical Operations and Medical and team
Excellent verbal, written, and interpersonal skills
1+ year Clinical Operations experience
Strong communication skills (verbal and written)
High initiative and self-starter attitude
Ability to operate in a fast-paced environment
Adaptable and flexible to a growing company

Clinical Trial Associate Resume Examples & Samples

Clinical project team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical trials
Responsible for tracking study budgets, including invoice and PO management/reconciliation, and accruals in support of the CTM and Finance
Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects
Responsible for set-up, filing, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files
Responsible for data entry into Clinical Trial Management Systems
Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues
Manage and track clinical and non-clinical supplies
Assists CTM with agendas and meeting minutes for clinical sub-team meetings
Assists CTM with logistics coordination for investigator meetings and external vendor meetings
Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs) and contracts with Sr. Manager Clinical Operations, legal, and finance departments

Senior Clinical Trial Associate Resume Examples & Samples

Assist in the development and implementation of recruitment strategies to increase patient recruitment into the trial (eg investigator meetings, update newsletters, drug accountability and delivery to investigational sites)
Work with the CRA and SM to update the CTMS and other trackers – which includes site status, details of patient recruitment into clinical trials, each individual’s progress through the trial, payments due to investigators, total paid to site, adverse events and other relevant patient related information (management of Clinical Trial Management Software)
Maintain a database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs. Plan, order and distribute non-drug clinical trial supplies eg clinical report forms, diary cards
Assist the SM with oversight of lab kits supplies to the sites
Assist the CRA during the preparation for the investigator study initiation visit
Can support the study team with the submission of clinical trials to ethics committees and competent authorities (either in Spain and in other countries) and responsible for reviewing investigators’ contracts
Maintain Trial Master File up-dated. Performs ongoing review of the TMF
Fulfill all responsibilities in accordance with Celgene SOPs / WPs and policies
Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory requirements
Participate in and contribute to Clinical Research meetings, study related meetings, training activities and cross-functional activities as appropriate
Contribute to general departmental administration and the development and continuous improvement of departmental procedures
Maintain and facilitate effective and productive communication and working relationships with all members of the department and staff in other functions
Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research Manager
Keep Celgene Tracking databases up to date and enter study information into National Clinical Trial Database where appropriate
Design and maintain contracts & administrative tracking tools
Support the production, coordination, completeness and accuracy of EC submissions in order to guarantee Celgene studies are submitted and approved in a timely fashion (for studies monitored in house)
Customize contracts to local requirements as applicable
Support/Perform Research Contract negotiations (in English & local language, where appropriate ) with Hospital/Institution, Central Contracts & Out-Sourcing Group, and Celgene’s Legal Group, to ensure local Start Up timelines are adhered to
Track Site payments to ensure timely payments are reflective of the contract’s schedule
Develop and maintain a good working knowledge of relevant protocols
Support Clinical Team (e.g. office or home based, and the contract CRAs) in administrative tasks and logistical support related to R&D Studies
Manage study material and study supplies, as applicable
Organize local Investigator Meetings, including agendas and minute production
Liaise closely with the CRAs, Study Managers team and CTAs
May conduct data query resolution and SAE information collection via facsimile, mail and telephone
Manage local translators & printers for required local documents
Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute of communications and study documents to study teams. These might be single documents or packages and may be safety [submissions, safety letters (SUSARs), Investigator´s Brochures, or Annual Safety Reports] or study (listings, trackers, essential TMF documents) related
Participate in SOP and WP development and contribute to process initiatives as required
Mentor and coach other CCTAs, as appropriate
Produce regular and adhoc Clinical Operations status reports as required
Act according the Manual of Good environmental practices and segregate waste materials of the job properly
Degree in administration or relevant education or comparable operating experience
Computer Literature: Good Knowledge at user level of Microsoft Office. Proficiency in Microsoft applications: Outlook, Word, Excel etc
Good database and data manipulation skills/ knowledge
Knowledge of ICH / GCP and regulatory guidelines/directives
5+ years experience as a clinical Trial Administrator or in a Clinical Research & Development

Clinical Trial Associate Resume Examples & Samples

Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary
Interaction and communication with investigator sites. Collection of relevant documentation, provision of study materials / documents
Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met. Contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups
Provide input on agendas, create materials, and liaise with meeting planners / coordinate logistics for key meetings; e.g. internal meetings or external investigator meetings
Help ensure accuracy of clinical trial management databases and resource/budget tracking tools, providing information, maintaining meeting minutes and following up on questions as necessary. Help check for discrepancies and take actions to correct as necessary
Identify areas for process or technology improvements with regard to tasks undertaken within the role
Assist in the ordering of clinical trial supplies
Assist in the compilation of the Clinical Study Report and its appendices
In collaboration with the Trial Document Specialist responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines
Audit existing Paper Trial Master Files, collect outstanding documents and archive after study is completed
Assist the CS in organizing investigator/site initiation meetings and/or first dose/monitoring visits
Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies
Must possess at least 1 year of direct experience supporting early phase clinical studies within a Pharma/Biotech environment
Demonstrated organizational skills and interpersonal skills
Good interpersonal skills, ability to successfully interact with a wide range of people
Ability to work in a team as well as independently if required and to manage multiple priorities with support
Office and clinical trial software IT computer literacy