The (in-house) Clinical Research Associate III supports in the planning, executing, monitoring and reporting of clinical trials. This role partners with internal and external team members to help ensure timely, quality conduct of study projects, including but not limited to site recruitment & feasibility, FDA/GCP/ICH and regulatory compliance, essential document review, and study document development and review.
Roles and Responsibilities
As a Clinical Research Associate III you will be responsible for operational study oversight activities as delegated by the Clinical Studies Manager, maintaining study team lists and trackers, and ensure compliance with Quality Standards (SOPs, GCP, etc.)
- Review of monitoring visit reports per plan, informing the Clinical Studies Manager of any critical findings and/or protocol deviations.
- Support TMF maintenance throughout the assigned study period, utilizing system reporting and hands on review against the TMF Index and expected documents listing.
- Support or perform other study related activities: support vendor training; perform user acceptance testing of systems (EDC, IWRS, etc.), as delegated by the Clinical Studies Manager.
- Review operational plans to ensure alignment with SOPs for assigned studies.
- Assist in the planning of Investigators’ and Kick-off meetings in close collaboration with the CSM, Clinical Lead (CL) and other functions, including the study vendors.
- Conduct oversight site visits as per the study vendor management plan.
- Assist in study team and other meeting scheduling as needed.
- Support vendors as primary contact for specific tasks.
- Collaborate with CQA for assigned studies to ensure timely resolution of CQA audit findings and collaborate with Inspection readiness to ensure study is ready for inspection (if applicable).
- Develop knowledge in the relevant indication and clinical trials methodology and apply the relevant information as appropriate.
- Participate in global departmental core activity processes and tasks.
Qualifications and Experience
- Bachelor’s degree in related science discipline.
- 4 years of experience in the pharmaceutical industry or at a clinical research site.
- Global trial experience.
- Monitoring experience.
- Sample management experience.
- Oncology and dose escalation study experience.