Clinical Study Start-Up Associate

Rapport Therapeutics•Boston, MA

9d•$90,000 - $110,000•Hybrid

About The Position

Rapport Therapeutics is seeking a Clinical Study Start-Up Associate to join its Clinical Operations team and help get clinical studies off the ground. The role supports study activation by coordinating start-up activities, managing essential documentation, and partnering with cross-functional teams to keep studies on track. It is based in the company’s Boston office, with onsite attendance Monday through Wednesday each week. The associate supports start-up from protocol finalization through site activation, maintains inspection-ready Trial Master Files (TMFs), tracks regulatory and site activation milestones, and coordinates with internal teams, CROs, and vendors. The role also provides operational and administrative support to Clinical Operations. Rapport develops precision neuromedicines using its Receptor Associate Protein (RAP) platform; its lead program, RAP-219, is being studied for focal epilepsy, with additional clinical trials in PGTCS and bipolar disorder.

Requirements

Bachelor's degree in Life Sciences, Healthcare, or a related field.
At least 3 years of experience supporting clinical trials in a biotech, pharmaceutical, or CRO environment, including required study start-up experience.
Experience supporting global, multi-center clinical trials, including site start-up and activation across multiple countries and regions.
Working knowledge of ICH-GCP guidelines and the clinical trial start-up process.
Experience reviewing, tracking, and maintaining essential study documents and TMFs.
Familiarity with CTMS, eTMF, and document management systems.
Strong organizational and project coordination skills, including the ability to manage multiple studies and competing priorities in a fast-paced environment.
Excellent attention to detail and ability to identify and resolve documentation gaps.
Strong written and verbal communication skills and ability to collaborate with cross-functional teams, CROs, and study sites.
Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
Self-motivated and proactive, able to work independently while contributing to a collaborative team environment.
Ability to maintain confidentiality and exercise sound judgment when handling sensitive clinical information.

Responsibilities

Support study start-up activities from protocol finalization through site activation.
Coordinate, review, track, and maintain essential study documents, including protocols, informed consent forms (ICFs), investigator brochures (IBs), regulatory documents, and site activation packages.
Perform quality checks of study documentation and maintain inspection-ready Trial Master Files (TMFs) in compliance with ICH-GCP and company SOPs.
Track study start-up milestones, including regulatory submissions, IRB/EC approvals, and site activation status.
Partner with Clinical Operations, Regulatory, CROs, and vendors to drive timely study start-up and resolve outstanding action items.
Prepare and maintain study trackers, templates, and other operational documents.
Support vendor contract administration, purchase orders, and invoice tracking.
Coordinate study meetings, document meeting minutes, and track follow-up actions.
Assist with clinical trial registrations, insurance documentation, and other study start-up requirements.
Provide operational and administrative support to the Clinical Operations team as needed.