Clinical Trial Specialist Job Description
Clinical trial specialist
provides advice to Local Study Delivery Teams and other MC-CRR personnel on Clinical Development processes, Procedural Documents, applicable Quality & Compliance manual documents, international guidelines such as ICH/GCP and local regulations.
Clinical Trial Specialist Duties & Responsibilities
To write an effective clinical trial specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Input of global study and site level data into the Clinical Trial Management System for Clinical Research Organization/Alliance Partner studies
Provisioning of accounts for access within the Clinical Trial Management System
Prepares study documents
May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, co-monitoring with local CRAs
Routinely participates in department and clinical trial team meetings and participate in collaborative efforts
Independently prepare and negotiate clinical site agreements at a site level, including PREDICT Agreements, Letter of Indemnifications (LOIs)
Act as an independent Country Coordinator on simple, moderate and complex projects in a non-client facing role
Liaisons with the Statisticians, Medical Monitors, Protocol Manager, and Medical Writers on all trials - operates as part of team to ensure the data best supports results and is consistent with other public forms of trial results
Leads a team of Clinical Trial Specialists and reports issues/concerns to DDU Manager of Study Operations
Clinical Trial Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Trial Specialist
List any licenses or certifications required by the position: RAC, SOCRA, ACRP, CIM, CIP, RA, CRA
Education for Clinical Trial Specialist
Typically a job would require a certain level of education.
Employers hiring for the clinical trial specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Health, Education, Science, Nursing, Pharmacy, Biological Science, Life Science, Healthcare, Business, Technical
Skills for Clinical Trial Specialist
Desired skills for clinical trial specialist include:
ICH and local regulatory authority drug research and development regulations
Clinical Trial Management Systems
Word
Excel
PowerPoint
Clinical Trial Management System
Ensure compliance with applicable ICH-GCP Guidelines
How they apply to clinical development
International and local regulations
PAREXEL training requirements
Desired experience for clinical trial specialist includes:
Serve as a resource for the project team or Clinical team, depending on workload can be delegated to other project related tasks
The coordination of all Regulatory and Ethics Committee tasks required for clinical trial site approval
Completing initial clinical trial submissions to the Regulatory Authority and Ethics Committees submission of Protocol Amendments
Responsible for bringing trial sites from a “Qualified” to “Active for Enrollment” status
Oversight of the trial set-up and responsible for liaising with other functional roles within the start-up team such as Feasibility Specialists, Contract Specialists, Clinical Research Associates and Project Assistants
You will develop collaborative relationships with investigative sites and Client companies during the start-up of clinical trials
Clinical Trial Specialist Examples
1
Clinical Trial Specialist Job Description
Job Description Example
Our growing company is looking to fill the role of clinical trial specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical trial specialist
- Complete routine departmental administrative tasks in an accurate and timely manner
- Responsible for training, education, and mentoring Clinical Trial Specialists
- Initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work of Study Operations
- Leads the execution of highly complex clinical trials for the drug development unit
- Reviews source documentation and communicates responses from sponsor regarding patient eligibility with nursing staff and physicians
- Educates Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
- Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 days of patient visits
- Creates study specific tools for source documentation including eligibility worksheets, screening checklists and intense sampling worksheets capturing vitals, ECGs, blood and tumor sampling
- Responsible for following patients’ response to treatment according to RECIST criteria in real time to assist in treatment decisions
- Participates in monitor visits monthly for each trial assigned
Qualifications for clinical trial specialist
- To review and negotiate all Regulatory documents for completeness
- To negotiate with Investigators, Research Nurses and Site staff where necessary
- Work with Clinical Research Associates to ensure essential documents are collected and submissions occur
- Bachelor’s degree in life science, health science or nursing
- Knowledge of applicable FDA guidelines and regulations in a pharmaceutical, clinical research or clinical setting would be a significant advantage
- Excellent communication skills and proven team player in multidisciplinary, international settings
2
Clinical Trial Specialist Job Description
Job Description Example
Our growing company is hiring for a clinical trial specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical trial specialist
- Monitors and maintains accurate and complete information concerning study cohort, slot allocation, toxicity and response on trial
- Responsible for reporting on dates of cohorts opening, number of slots allocated to SCRI other sites and dates of all patients starting treatment
- Timely and accurate completion of Serious Adverse Events (approximately 2 per week)
- Intense sponsor interaction including daily phones calls and e-mails to update on patient status toxicity and response
- Present data on weekly teleconferences with sponsors to update on patients including last visit, any toxicity, and response
- Assist Drug Development Program Sites as needed with trial specific needs including protocol assessment/eligibility issues and data entry questions (if applicable)
- Key point of contact for liaison with third party vendors
- Representing regulatory perspective in cross functional process improvement initiatives and cross therapy area department initiatives
- Inputting into key face to face study kick off teams and workshops to design and deliver regulatory strategies tailored for all countries involved & mitigate any potential issues which could impact development programme timelines
- Providing core information for country application forms for affiliates, author EU Clinical Trial Application forms, review CTA documents to ensure compliance with current requirements
Qualifications for clinical trial specialist
- Knowledge of the principles and practices of computer applications in database management
- Open minded, motivated personality with focus on details
- Fluent verbal and written English, German of advantage
- Bachelor’s degree in a life science field with 2+ years of technical or preferably scientific writing experience
- Determine the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries
- Effectively lead CTAp Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations
3
Clinical Trial Specialist Job Description
Job Description Example
Our innovative and growing company is looking for a clinical trial specialist. 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 specialist
- Triaging and collating responses to questions from Competent Authorities and dictate compliance times
- Acting as primary interface to and from personnel in affiliates who interface with local agencies for clinical trials
- Participating in continuous improvement initiatives within CTRG and cross functionally
- Supporting internal and external inspections and cross functional process improvement initiatives
- Under supervision, regularly informing regulatory management of important timely issues and the impact on the global program
- Translate Clinical Development requirements into an actionable supply plan
- Assess issues with regards to study design, supply availability and timelines
- Determine distribution strategies
- Oversee identification, appropriate provision and presentation of comparator, concomitant medication and rescue mediation to meet study requirements
- Draft clinical label text for review and approval
Qualifications for clinical trial specialist
- Liaise with local and central teams and CRO, as required, to ensure that study start up activities are in compliance with study timelines and local regulations
- Optimally compile and distribute the final CTAp dossier and subsequent Substantial amendments to country applicants, for submission to Ethics Committees and Competent Authorities
- Bachelor degree in Life Sciences, Allied Health, Pharmacy, Nursing
- Thorough understanding of GCPs, ICH Guidelines and local country guidelines or regulations as they apply to protocol/site management
- Knowledge of general clinical research including project management issues, important milestones and strategies to ensure timelines are met
- Knowledge of the pharmaceutical industry and of pre-clinical, clinical, regulatory and commercial components
4
Clinical Trial Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical trial specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical trial specialist
- Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met
- Develop, send, collect, review, and process clinical trial related documents in compliance with requirements set forth by regulatory agencies (e.g., FDA, TPD, EMEA, ICH-GCP, SOPs and working practice guidelines)
- Set-up, maintain, oversee, reconciles and QC the trial master files
- Assist with the preparation of study amendments, model informed consent forms, laboratory manuals, and other clinical trial related documents as assigned
- Provide study status updates at regular intervals to operational study management team members
- Collaborates on the Clinical Operations team on the development of certain study specific plans and/or processes
- Train third parties on procedures and assist with system support
- Participate in cross functional internal study team meetings and take minutes as requested
- The Lead Clinical Trial Specialist reports to the Sr
- Perform quality control (QC) of Sponsor and/or Clinical Research Organization (CRO)-issued data queries to ensure the accuracy of site responses in EDC
Qualifications for clinical trial specialist
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Capability to define process flows and procedures, to modify and improve them when necessary
- Proficient use of CTMS and related regulatory tracking systems
- Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry
- Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others
- Experience in effective implementation of clinical plans/documents and document preparation
5
Clinical Trial Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical trial specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trial specialist
- Support Clinical Operations and Clinical Data Management study team members relative to ongoing data review including running various data cleaning reports
- Coordinate the conduct of multicenter clinical trial protocols, including study site selection and activation, patient enrollment, electronic case report form design, specimen shipping, data monitoring, safety review, and other protocol-related tasks
- Track each site through local regulatory review and contract execution process, evaluate for recurrent problems, development and implement systems to decrease delay in site activation process
- Collect and review regulatory documents from participating sites prior to study activation, conduct study start-up meetings, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines
- Review subject eligibility and registration request
- Conduct on-site training and monitoring visits as needed
- For IND studies, maintain accurate and up-to-date documents and submissions
- Facilitate the full cycle of the protocol approval process – development, submission, contract negotiation, budget development, interaction with Cancer Center Cores
- Assist PI with abstracts and manuscripts preparation
- When needed, recruit and train research data management and regulatory personnel within the Program
Qualifications for clinical trial specialist
- Clinical experience with [therapeutic area or disease] is preferred
- Ability to work in multiple parallel projects and share learnings
- Previous experience working in an international team environment within a matrix organisation
- Experience in planning and coordination of study initiation
- Bachelor's degree in in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required
- Relevant advanced degree in life sciences is preferred