Clinical Trial Associate

Tech Observer • Billerica, MA

233d

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), protocols, 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 communication with investigators and project teams.

Requirements

• Experience in clinical research or a related field.
• Knowledge of Good Clinical Practice (GCP) and clinical trial regulations.
• Strong organizational skills and attention to detail.
• Proficiency in data entry and database management.
• Ability to communicate effectively with team members and external stakeholders.

Nice To Haves

• Experience with Trial Master File (TMF) management.
• Familiarity with Investigator site payments and financial tracking in clinical trials.
• Previous experience in a support role for clinical research associates.

Responsibilities

• Coordinate and perform the collection, distribution, and storage/archival of data/study materials for assigned studies during clinical research trials.
• Ensure that assigned trials comply with applicable regulations, GCP, protocols, and Sponsor SOPs.
• Maintain databases of patient information and assist in grant proposal information collection and correspondence writing.
• Maintain an Investigator database and search for new potential Investigators for upcoming trials.
• Enter data from forms and documents into databases as required for assigned studies.
• Provide assistance to the operational team by organizing files, projects, and data for assigned studies.
• Maintain the Trial Master File (TMF) in coordination with the Assistant Project Manager (APM) or Project Manager (PM) for assigned studies.
• Assist Clinical Research Associates (CRA) in maintaining the Site Master File (SMF).
• Assist with routine in-house data verification and quality control to ensure data integrity and consistency with prescribed study protocols.
• Utilize Standard Operating Procedures (SOPs) in a timely manner.
• Assist CRA in preparing for investigator meetings, including liaison, presentations, and follow-up for assigned studies.
• Assist CRA in tracking Investigator site payments and liaising 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 study progress and relevant information to the Project Manager, CRA, and other project team members as requested.
• Assist 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) or Assistant Project Manager (APM).

Benefits

• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Publishing Industries
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees