Our client, a healthcare research company in Boston, is hiring a Clinical Research Coordinator to support the daily operation of multiple active clinical trials. The coordinator will serve as a primary contact for study participants, investigators, and sponsors, and will help keep each study running in line with its protocol and applicable regulations.
This role is on-site and involves direct participant contact, data collection, and regulatory documentation. The coordinator will work closely with principal investigators, research nurses, and data managers to meet enrollment targets and maintain accurate study records.
Candidates should have prior experience coordinating clinical trials and a working knowledge of Good Clinical Practice. The position suits someone who is organized, detail-oriented, and comfortable managing several studies at once.
Responsibilities
- Screen, recruit, and enroll eligible study participants according to protocol criteria
- Obtain and document informed consent in compliance with IRB and regulatory requirements
- Schedule and conduct study visits, including collecting vitals, specimens, and assessments
- Enter and verify study data in electronic data capture systems and resolve queries promptly
- Prepare and maintain regulatory binders, IRB submissions, and amendment documentation
- Report adverse events and protocol deviations to investigators, sponsors, and the IRB
- Coordinate with sponsors, monitors, and auditors during site visits and inspections
- Track enrollment progress and study milestones and report status to the principal investigator
Requirements
- Bachelor's degree in life sciences, public health, nursing, or a related field
- 3 or more years of experience coordinating clinical trials
- Working knowledge of Good Clinical Practice (GCP) and FDA regulations
- Experience with electronic data capture and clinical trial management systems
- Current CITI or equivalent human subjects research certification
- Strong organizational skills and attention to detail
- Clear written and verbal communication skills
- SOCRA or ACRP certification preferred
Benefits
- Medical, dental, and vision insurance
- 401(k) with employer match
- Paid time off and paid holidays
- Tuition and professional development assistance
- Pre-tax commuter benefits for MBTA and parking
- Life and disability insurance
- Employee wellness program
- Support for SOCRA or ACRP certification fees