Clinical Study Start-Up Lead – Boston Onsite

Rapport Therapeutics; Boston (MA); On-site; USD 90,000 - 110,000; Full time

Job summary

Rapport Therapeutics, based in Boston, MA, is seeking a Study Start-Up Associate to join the Clinical Operations team onsite 3 days a week. You will drive study activation by coordinating start-up activities, maintaining critical documentation, and partnering with cross-functional teams to keep studies on track.

The role requires 3+ years in clinical trial start-up, familiarity with ICH-GCP, and experience with TMFs. Expect a fast-paced environment with close collaboration across departments.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related field.
• 3+ years of experience supporting clinical trials in biotech/pharma/CRO with start-up experience.
• Experience supporting global, multi-center trials across multiple countries/regions.
• Working knowledge of ICH-GCP guidelines and start-up processes.
• Experience reviewing, tracking, and maintaining essential study documents and TMFs.
• Familiarity with CTMS, eTMF, and document management systems.
• Strong organizational and project coordination skills with ability to manage multiple studies.
• Excellent attention to detail and ability to identify/document gaps.
• Strong written and verbal communication; collaboration across teams, CROs, and study sites.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Self-motivated, proactive, and able to work independently.

Responsibilities

• Support study start-up activities from protocol finalization through site activation.
• Coordinate, review, track, and maintain essential study documents (protocols, ICFs, IBs, regulatory docs, site activation packages).
• Perform quality checks of study documentation and maintain inspection-ready TMFs per ICH-GCP and SOPs.
• Track start-up milestones including regulatory submissions and IRB/EC approvals.
• Partner with Clinical Operations, Regulatory, CROs, and vendors to drive timely start-up and resolve action items.
• Prepare and maintain study trackers, templates, and other operational documents.
• Support vendor contracts, purchase orders, and invoice tracking.
• Coordinate study meetings and document minutes; track follow-up actions.
• Assist with trial registrations, insurance docs, and other start-up requirements.
• Provide operational support to the Clinical Operations team as needed.

Skills

Project coordination

Cross-functional collaboration

Attention to detail

Organizational skills

Communication

Education

Bachelor’s degree in Life Sciences, Healthcare, or related field

Tools

CTMS

eTMF

Document management systems

Job description

Rapport Therapeutics, based in Boston, MA, is seeking a Study Start-Up Associate to join the Clinical Operations team onsite 3 days a week. You will drive study activation by coordinating start-up activities, maintaining critical documentation, and partnering with cross-functional teams to keep studies on track.

The role requires 3+ years in clinical trial start-up, familiarity with ICH-GCP, and experience with TMFs. Expect a fast-paced environment with close collaboration across departments.