Senior Clinical Trial Associate

Overview

Summary of job description:

The Senior Clinical Trial Associate Clinical Operations (SrCTA) will be responsible for supporting the clinical operations team. The SrCTA will participate in clinical activities to support and facilitate the efficient conduct of the clinical research goals. The SrCTA will report to the Director Operational Process.

• Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.

Responsibilities

Key responsibilities:

• Work closely with clinical trial/project manager and study team to support clinical trials

• Assist in the development of clinical trial documents including protocols, manuals, SOPs, trackers, policies.

• Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes

• Assist in updates for all clinical trials tracking tools for Trial Master File (TMF), monitoring visits, enrollment, laboratory samples and clinical trial agents (drugs/biologics), data cleaning, other vendor tracking and training.

• Assist in informed consent development and version tracking

• Assist in collection and review of essential documents

• Assist in update of clinical SOPs, training files on SOPs/other documents

Other Responsibilities:

• Assist in reporting for Senior Management updates

• Support trial manager in vendor management as needed

Qualifications

Educational requirements:

• BS degree in science, nursing, allied health. Other degrees/experience will be considered based upon work experience.

Experience and skill requirements:

• 4+years clinical research experience in industry or Contract Research Organization (CRO).

• Knowledge and training on Good Clinical Practice (GCP) for clinical research studies

• Experience working with clinical sites, principal investigators, clinical operations staff and CROs

• Computer skill should include high proficiency with Microsoft Office software

Location:

• Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.