Clinical Trial Associate

Tech Observer • Billerica, MA

349d

About The Position

The position involves coordinating and performing various tasks related to the collection, distribution, and storage of data and study materials generated during clinical research trials. The individual will ensure that assigned trials comply with applicable regulations, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs) set by the Tech Observer and Sponsor. Responsibilities include maintaining databases of patient information, assisting with grant proposals, and managing correspondence. The role also requires maintaining the Investigator database and searching for new potential Investigators for upcoming trials.

Responsibilities

• Coordinate and perform the collection, distribution, and storage/archival of data/study material/study supply generated during clinical research trials.
• Ensure that assigned trials comply with applicable regulations, GCP, Protocol, and Sponsor SOPs.
• Maintain databases of patient information and assist in grant proposals and correspondence.
• Maintain the Investigator database and search for new potential Investigators for upcoming trials.
• Enter data from forms and documents into databases as required for assigned studies.
• Organize files, projects, and data for the operational team, keeping them up to date for assigned studies.
• Maintain the Trial Master File (TMF) in coordination with the APM/PM for assigned studies.
• Assist the CRA in maintaining the Site Master File (SMF).
• Assist with routine in-house data verification and quality control, ensuring data integrity and consistency with prescribed study protocol for assigned studies.
• Utilize SOP concepts and practices in a time-sensitive manner.
• Assist the CRA in investigator meeting preparation, liaison, presentations, and follow-up for assigned studies.
• Track Investigator site payments and liaise with sites for follow-up on open issues, recruitment status updates, and required documents for TMF.
• Ensure timely submission of protocol/consent documents for EC/IRB approval and follow up on approval status from site personnel for assigned studies.
• Communicate progress of the study and relevant information to the Project Manager/CRA and other project team members as requested for assigned studies.
• Assist the CRA in archiving study files upon completion of a clinical trial.
• Coordinate with vendors involved in a clinical trial as requested for assigned studies.
• Perform other responsibilities as delegated by the Project Manager (PM)/Assistant Project Manager (APM).

What This Job Offers

• Industry: Publishing Industries
• Number of Employees: 251-500 employees