Clinical Trial Assistant
Job Title: Clinical Trial Assistant
Reports To: Clinical Trial Manager
FLSA Status: Exempt
The Clinical Trial Assistant is responsible for administration, maintenance and coordination of the logistical aspects of the company’s clinical trials according to Good Clinical Practice and relevant SOPs. This role is also responsible for being a pivotal point of contact for the Clinical Operations team and any contract organizations used.
Key Accountabilities/Core Job Responsibilities:
- Assist in the preparation of project and study-related documents including: informed consent forms (ICFs), pharmacy manuals, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
- Assist with coordination of case report forms (CRFs), study guides, study reference binders, patient diaries, and other forms, including participating in the EDC and IXRS specification process and user acceptance testing.
- Assist in the coordination of the preparation of clinical site budgets.
- Assist in monitoring and tracking clinical trial progress and providing status update reports and study metrics.
- Assist in the planning of Investigator Meetings, including creating presentations, as required.
- Prepare meeting agendas and minutes.
- Facilitate communications on behalf of the Study Team to include correspondence, mass mailings, email communications, etc. Assist in the review of clinical data in the CRF, data listing, and report table levels.
- Assist in management of the Trial Master File (TMF), including vendor management as applicable.
- Perform other duties as assigned.
- Good organization and planning skills
- Strong interpersonal skills and communication skills (both written and oral)
- Ability to problem-solve
- Excellent comprehension of Good Clinical Practices (GCP) and basic concepts of clinical research
- This position requires a minimum of 2 years of experience in the pharmaceutical/clinical research environment with at least 1 year of CTA experience.
This position has no managerial responsibilities
Education Requirements (degree, certifications, etc.):
· BA/BS in health-related field or scientific discipline or equivalent combination of education and related-work experience.
- Experience with development of prospective site-selection criteria
- Ability to deal with time demands, incomplete information or unexpected events
- Experience in interactions with outside vendors, e.g., CROs and contract labs
- Experience with assisting in the administration of site budgets
- Experience with electronic TMF (eTMF)
- Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure.
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.