Our client, a clinical research company based in Boston, is seeking a Clinical Research Coordinator to support the day-to-day operation of multiple Phase II and Phase III clinical trials. This is a full-time, on-site position working directly with principal investigators, study sponsors, and enrolled participants.
The Clinical Research Coordinator will manage participant recruitment, screening, and enrollment, ensure that study procedures follow the approved protocol, and maintain accurate regulatory and source documentation. The role requires close attention to detail and the ability to manage several studies at once.
This position suits a candidate with prior clinical research experience who is comfortable working in a regulated environment and communicating with both clinical staff and study participants.
Responsibilities
- Screen, recruit, and enroll eligible participants according to protocol inclusion and exclusion criteria
- Conduct study visits and collect data, vitals, and specimens as outlined in the protocol
- Maintain accurate source documents and enter data into electronic data capture systems
- Prepare and submit documents to the Institutional Review Board, including amendments and continuing reviews
- Track and report adverse events and protocol deviations within required timelines
- Coordinate with sponsors, monitors, and auditors during site visits and inspections
- Maintain regulatory binders and investigational product accountability records
- Schedule participant visits and follow up to support retention
Requirements
- Bachelor's degree in life sciences, nursing, public health, or a related field
- 2 or more years of clinical research coordination experience
- Working knowledge of ICH-GCP guidelines and FDA regulations
- Experience with electronic data capture systems and clinical trial management software
- Strong organizational and documentation skills
- Clear written and verbal communication skills
- Ability to manage multiple studies and deadlines at once
- CCRP or SOCRA certification preferred
Benefits
- Medical, dental, and vision insurance
- 401(k) with employer match
- Paid time off and 10 paid holidays
- Tuition and professional development support
- Certification exam fee reimbursement
- Employer-paid life and disability insurance
- Subsidized MBTA pass
- Annual performance bonus eligibility