Clinical Trial Assistant Job Description

Clinical Trial Assistant Job Description

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Clinical trial assistant provides clinical oversight and management for senior clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.

Clinical Trial Assistant Duties & Responsibilities

To write an effective clinical trial assistant job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial assistant job description templates that you can modify and use.

Sample responsibilities for this position include:

Perform and/or maintain data entry in internal Quality systems
Prepare investigator budget payments and tracking systems
Plan and conduct Therapeutic Area meetings
Assist the Therapeutic Area Head in aligning/ensuring consistent processes applied across Therapeutic Area and Franchise as part of the deliverables of the Clinical Development Leadership Team
Help with resource planning and tracking
Help to identify resource, scientific, operational and learnings gaps within the Therapeutic Area and recommending/supporting remediation solutions
Support the educational mission of the Therapeutic Area and professional development
Coordinate, track and manage Therapeutic Area information sharing and Therapeutic Area
Create and maintain Study Files (hard-copy and electronic)
Arrange meetings and assist with travel coordination

Clinical Trial Assistant Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Trial Assistant

List any licenses or certifications required by the position: CCRP

Education for Clinical Trial Assistant

Typically a job would require a certain level of education.

Employers hiring for the clinical trial assistant job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Communication, English, Medical, Life Sciences, Education, Life Science, Finance, Business, Health

Skills for Clinical Trial Assistant

Desired skills for clinical trial assistant include:

Applicable protocol requirements as provided in company training
Excel and PowerPoint
Microsoft Word
Applicable clinical research regulatory requirements
Applicable protocol requirements
Good Clinical Practice guidelines
Excel
Relevant operational procedures
Systems
Systems and quality guidelines regarding clinical studies

Desired experience for clinical trial assistant includes:

Prepare and distribute meeting agendas/minutes
Facilitate purchase orders and track clinical supply inventory
Assist in processing of invoices
Assist in preparation of regulatory binders, study and/or pharmacy manuals
Responsible for maintaining and communicating project metrics via study trackers
Responsible for collecting, tracking and archiving Essential Documents

Clinical Trial Assistant Examples

1

Clinical Trial Assistant Job Description

Job Description Example
Our growing company is hiring for a clinical trial assistant. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trial assistant
  • Preparation of document/spreadsheets for data reviews
  • May include site and vendor interaction
  • Provide technical support by tracking and reporting of trial budgets, invoices, and related financial documentation activities
  • Create and maintain vendor contact lists other internal lists
  • Coordinates and provides technical oversight for both internal/external meetings
  • You will have between 12 to 15 direct reports
  • Organize and maintain project working files and track critical documents
  • Essential Functions required for the job
  • Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
  • Assist in creating, assembling and coordinating shipping of study materials
Qualifications for clinical trial assistant
  • Excellent demonstrable verbal and written communication skills
  • Able to work within a team with a service oriented approach
  • Able to perform routine assignments with general instructions and new assignments with detailed instructions
  • BA, BS, AA or AS degree in life sciences, nursing or related disciplines
  • Bachelors degree in an administrative discipline or equivalent experience
  • Fluent English and Lithuanian
2

Clinical Trial Assistant Job Description

Job Description Example
Our company is looking to fill the role of clinical trial assistant. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical trial assistant
  • Effectively uses available tools and systems to gather information needed to manage study activities and to provide feedback to the appropriate team members
  • All administration and preparation work for trial site set-up and related tracking activities
  • Help and support the Country Approval Specialists, CRAs and Contract Specialists with administrative tasks
  • Preparation of submission packages
  • Set-up and maintenance of project files and documentation according to Standard Operating Procedures and Working Practices
  • You will need to ensure high levels of accuracy, to manage and maintain clinical study documentation
  • Contact external and internal individuals
  • Track and reconcile essential documents for Central Master Files according to ICH GCP and/or ISO 14155 and company procedures
  • Work within established SOPs
  • Prepare and compile study related materials including investigator meeting binders, training manuals, Site regulatory binder, Site study binders
Qualifications for clinical trial assistant
  • Ability to mentor and train new Project Assistants as needed
  • Excellent English & Danish language skills
  • Act as a central contact for the team for assigned project communications, correspondence and associated documentation
  • Support the preparation, handling, distribution, filing, and archiving of clinical documentation and reports
  • 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 arrange and attend internal and external meetings, helping to produce presentation materials and generate meeting minutes
3

Clinical Trial Assistant Job Description

Job Description Example
Our growing company is looking to fill the role of clinical trial assistant. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trial assistant
  • Support study feasibility activities and perform database/web searches for sites as needed
  • Track and assist with processing site/vendor payments
  • Participate in testing of specifications and edit checks for internal
  • Assist with the preparation and distribution of meeting agendas and minutes
  • Support and correspond with sites to identify site specific needs
  • May deliver training related to day-to-day responsibilities for new CTA and CTM hires within department
  • May provide administrative support to manager/group as assigned
  • Prepare and oversee expense account reporting
  • Schedule and coordinate new hire candidate interviews
  • Leading broad and/or cross-functional projects for the Clinical Operations team and managing project timelines and deliverables
Qualifications for clinical trial assistant
  • Responsible for reconciliation of monthly invoices/PO management
  • Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports
  • A BSN
  • Minimum Diploma or STPM/SPM or equivalent with at least 2-3 years experience in administration
  • Actively enrolled college/university student, sophomore year student preferred
  • Ideal candidate would be a self-starter with the ability to work independently and meet timelines
4

Clinical Trial Assistant Job Description

Job Description Example
Our growing company is looking to fill the role of clinical trial assistant. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical trial assistant
  • Performing other related activities as assigned
  • Coordinate patient study visits and procedures
  • Coordinate with the investigator, the scheduling, preparation and provision of education and information regarding clinical protocol s to associated health care personnel and study subjects
  • Collect and maintain a file of regulatory documents, study documentation and communication for each study
  • Obtain informed consent from potential study candidates
  • Consistently track and update subject participation in database
  • Candidate with 2-4 yrs
  • Provide day-to-day departmental/project support activities, such as managing study supply inventory and orders, shipping, filing, faxing
  • Maintain databases/spreadsheets and compile reports
  • Sets up files related to a variety of clinical trials
Qualifications for clinical trial assistant
  • Team player with excellent customer focus
  • Must be available to work a minimum of 12 week, full time
  • Self-starter and fast learner, with the ability to work independently collaboratively
  • Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements preferred
  • Excellent communication, writing, organizational skills , attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn
  • Ability to effectively interact with the study team, study sponsors, the Research Institute, and the IRB to accomplish goals in a timely manner
5

Clinical Trial Assistant Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of clinical trial assistant. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical trial assistant
  • Knowledge in various processes and systems to fully support the protocol teams and clinical trial processes
  • Maintain, verify, process, and makes updates to PFE systems (including Registry), spreadsheets / documents as needed
  • Generate reports from PFE systems (CAL, RT2) as directed to support completion of and tracking of submission deliverables
  • Coordinates ordering and tracking of trial supplies
  • Complete Process Data Collection Forms
  • Provides general support to the Clinical Operations team on other clinical trial related duties and tasks, as required
  • To handle all study related administrative tasks by utilizing technology effectively to support the clinical trial development processes with the use of Clinical Trial Management System at the Protocol, Country and Site level
  • Coordinating archiving of study documents
  • Answers and resolves routine questions independently
  • Partners with the study team to ensure overall study management and adherence to internal SOPs, policies, local regulatory requirements and department processes
Qualifications for clinical trial assistant
  • High school Diploma or Bachelors degree in Life Science preferred
  • Bachelor’s degree in life sciences, scientific or other relevant discipline and 2 – 4 years of relevant experience in the health care, biotechnology or diagnostics industry
  • High school diploma or Associate’s Degree and 3 – 5 years of related experience in the health care, biotechnology or diagnostics industry
  • Demonstrated competency in the utilization of Microsoft tools, specifically Word
  • Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus
  • People Relationships

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