Clinical Research Coordinator

knownwell

14d•$60,000 - $80,000•Hybrid

About The Position

The Clinical Research Coordinator (CRC) oversees and coordinates clinical trials, ensuring studies are conducted in compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. The CRC serves as a primary liaison among the clinical research team, patients, and external stakeholders, and supports the efficient and timely execution of research projects. This role is based at knownwell clinics in Needham and Woburn in the Greater Boston Area and is hybrid, with most work conducted on-site. The position does not offer relocation assistance. The CRC coordinates study operations from recruitment and enrollment through closeout, supports participant safety and informed consent, manages study data and documentation, and helps ensure regulatory compliance. The role collaborates with the Principal Investigator, Clinical Research Manager, research staff, sponsors, and CROs. Clinical duties include phlebotomy, EKG administration, vital-sign assessment, and processing blood samples according to protocol.

Requirements

Bachelor's degree in a related field, such as life sciences, nursing, or healthcare.
GCP, BLS, IATA, and CSSR certifications, or willingness to acquire them if hired.
At least 3 years of experience in clinical research and industry environments.
Solid understanding of drug development processes and FDA and ICH-GCP guidelines.
Proficiency with multiple software systems and computer technology.
Strong organizational, leadership, and time-management skills.
Excellent written and verbal communication skills.
Ability to work independently and as part of a multidisciplinary team.
Experience working on collaborative, diverse, and feedback-driven teams.
Demonstrated ability to adapt and thrive through periods of change.
Ability to lift and carry study materials weighing up to 50 pounds.
Ability to sit or stand for extended periods.

Nice To Haves

CCRC certification and/or a master's degree.
At least 2 years of experience with independent trial management.
Expert phlebotomy skills are strongly preferred.

Responsibilities

Coordinate and manage clinical trial activities, including patient recruitment, screening, and enrollment.
Schedule and oversee patient visits and ensure timely collection of data and samples according to study protocols.
Oversee site initiation, monitoring, closeout activities, and equipment calibration.
Maintain case report forms, consent forms, and other essential study records.
Review monitoring follow-up letters and ensure timely completion and resolution of identified issues.
Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs).
Manage receipt, shipment, and storage of study drugs and trial samples, and ensure proper handling and storage of study materials, medications, and biological samples.
Generate invoices for study sponsors as applicable or assigned.
Serve as a main point of contact for study participants, answer questions, and provide information about protocols, treatment options, and expected outcomes.
Assist with informed consent and help participants understand study risks, benefits, and requirements.
Monitor and document participant progress and help maintain patient safety and well-being.
Perform phlebotomy, EKG administration, vital-sign assessment, and protocol-based blood sample processing, including centrifuging and aliquoting.
Enter, maintain, and monitor study data in CTMS, EDC, and other relevant databases.
Perform data quality-control checks and collaborate with site staff, sponsors, or CROs to resolve data discrepancies or issues.
Maintain current knowledge of federal and global regulations, including ICH-GCP and FDA guidelines, and ensure compliance with applicable and sponsor-specific requirements.
Assist with preparation and submission of study protocols, amendments, and regulatory documents to the IRB.
Prepare study materials, including training materials, regulatory binders, manuals, and supporting documentation.
Train study staff on regulatory requirements and ensure compliance with study protocols.
Maintain regulatory binders and drug-accountability documents and archive study documentation at study end according to Sponsor and FDA timelines.
Work with the Principal Investigator, Clinical Research Manager, and research staff to support study success.
Communicate study progress and patient enrollment updates to sponsor representatives.
Assist with study recruitment strategies and participate in outreach activities.