Clinical Trial Associate - (In-House)
In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.
The Clinical Trial Associate (CTA) will provide clinical study support for multiple clinical studies/programs, ensuring efficient support of clinical trials in a matrix environment. The CTA provides project support as needed to Clinical Operations (Project Managers and CRAs) to help execute the trials. Key accountabilities include tracking of documents, generating reports, TMF oversight, meeting organization with minutes and agenda development, assistance with creation of study plans, logs and other tasks as assigned. This is an in-house position and will report to the Director/Associate Director, Clinical Operations.
Job Duties and Responsibilities:
Responsibilities may include, but are not limited to:
- Review and track documents for the Trial Master File (TMF); assist in overall management of TMF
- Assist with auditing and reconciliation for all study related documents for trials
- Provide support to vendor or sponsor Clinical Trial Management System(s).
- Track, review and process study related documents (CVs, FDA 1572, lab certifications, CDAs, ethics approvals, etc)
- Coordinate logistics and scheduling for project and group meetings.
- Developing and distributing agendas and recording minutes for meetings as requested.
- Request and track site level CDAs
- Create and maintain project level trackers as needed
- Update and maintain internal share sites
- Distribute communications to external partners
- Other duties as assigned
- Bachelor’s degree, preferably in a scientific field
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent, at a minimum of 2 years
- Demonstrates core understanding of medical terminology and clinical trial activities
- Thorough understanding of ICH GCP guidelines
- Understanding of clinical trial processes from study start-up through study closure
- Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
- Ability to efficiently perform multiple tasks and manage changing priorities
- Self-motivated, assertive and able to function independently or as part of a team
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
- Proven problem solving and decision making skills
- Ability and willingness to travel 10-20% (domestic and international)