Student Worker – Clinical Document Specialist

Job Description:

Every day, we rise to the challenge to make a difference and here’s how the Student Worker – Clinical Document Specialist role will make an impact:

Key responsibilities for this role include:

• Assist with organizing, naming, and filing documents within the eTMF system.

• Perform clinical trial document quality control (QC) checks to ensure accuracy and compliance.

• Support TMF reconciliation and audit readiness efforts.

• Help generate and update TMF status reports, trackers, and filing metrics.

• Participate in internal TMF reviews and assist in identifying gaps or duplicate documents.

• Assist in preparing documentation packets for regulatory submissions.

• Communicate with clinical team members to follow up on document submissions, clarification requests, or outstanding deliverables.

• Support document migration activities from shared drives, TEAMS, or other platforms into the eTMF.

• Attend team meetings and contribute to discussions on document management best practices.

The minimum qualifications for this role are:

• Currently enrolled in a graduate program (preferably in Life Sciences, Public Health, Regulatory Affairs, Clinical Research, or a related field).

• Minimum GPA of 3.0 preferred.

• Strong attention to detail and commitment to document accuracy and integrity.

• Excellent written and verbal communication skills.

• Proficient in Microsoft Office Suite, especially Excel, Word, and Outlook.

• Familiarity with document management systems or cloud-based platforms.

• Ability to learn and follow structured processes and SOPs.

• Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.

• Comfortable working independently in a remote setting and collaborating virtually with cross-functional teams.

• Interest in clinical trials, regulatory compliance, or pharmaceutical development.