Clinical Research Coordinator

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🔍 The Clinical Research Coordinator (CRC) is responsible for overseeing and coordinating all aspects of clinical trials, ensuring that studies are conducted in compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. The CRC will act as the primary liaison between the clinical research team, patients, and external stakeholders, ensuring the efficient and timely execution of clinical research projects.

Location: Greater Boston Area Clinics (Needham and Woburn)

On-site Requirements: Primarily on-site (4-5 days/wk)

*knownwell does not offer relocation assistance*

What you'll do:

Study Coordination:

- Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment.

- Schedule and oversee patient visits, ensuring timely collection of data and samples in accordance with the study protocol.

- Oversee site initiation, monitoring, closeout activities, and equipment calibration to ensure compliance with study protocols and regulations.

- Maintain study documentation, including case report forms, consent forms, and other essential study records.

- Review monitoring follow-up letters to ensure timely completion and resolution of identified issues.

- Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs).

- Manage the receipt, shipment, and storage of study drug and trial samples.

- Ensure proper handling and storage of study materials, medications, and biological samples.

- Generate invoices for study sponsors as applicable or assigned.

Patient Interaction:

- Serve as the main point of contact for participants, answering questions and providing information regarding study protocols, treatment options, and expected outcomes.

- Ensure patients understand the study’s risks, benefits, and requirements by assisting in the informed consent process.

- Monitor and document patient progress throughout the study, ensuring that their safety and well-being are maintained.

- Proficient in phlebotomy, EKG administration, and vital sign assessment. Skilled in processing blood samples per protocol, including centrifuging and aliquoting.

Data Management:

- Enter, maintain, and monitor study data in the clinical trial management system (CTMS, EDC) and other relevant databases.

- Perform quality control checks to ensure the accuracy and completeness of data.

- Collaborate with trial site staff, sponsor or CRO to resolve any discrepancies or issues with study data.

Regulatory Compliance:

- Stay current with federal and global regulations, including ICH-GCP and FDA guidelines, and ensure the study's adherence to applicable regulatory requirements, as well as sponsor-specific requirements.

- Assist with the preparation and submission of study protocols, amendments, and regulatory documents to the Institutional Review Board (IRB).

- Prepare site materials, including training materials, regulatory binders, manuals, and support documentation, ensuring alignment with regulatory guidelines and ethical standards.

- Conduct training for study staff on regulatory requirements and ensure compliance with study protocols.

- Maintain regulatory binders and drug accountability documents for each study.

- Archive all documentation at the end of the study per Sponsor and FDA-required timelines.

Study Team Collaboration:

- Work closely with the Principal Investigator, Clinical Research Manager, and other research staff to ensure the study’s success.

- Communicate with sponsor representatives, providing regular updates on study progress and patient enrollment.

- Assist with study recruitment strategies and participate in outreach activities.

Who you are:

Education:

- Bachelor's degree in a related field (e.g., life sciences, nursing, healthcare); CCRC Certification, and/or master’s degree preferred.

- GCP, BLS, IATA, and CSSR Certifications (or willingness to acquire if hired).

Experience:

- 3+ years of experience in clinical research and industry environments. 2+ years of experience with independent trial management preferred.

- Solid understanding of drug development processes, FDA, and ICH GCP guidelines.

- Proficiency in using multiple software systems and computer technology.

Skills:

- Strong preference for candidates with expert phlebotomy skills.

- 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.

- Proven history of adapting and thriving through periods of change.

Physical Demands:

- Ability to lift and carry study materials (up to 50 lbs).

- Ability to sit or stand for extended periods.

- Occasional travel may be required for study site visits, meetings, or training sessions.

Pay & Perks:

🏢 Onsite Opportunity

🩺 Medical, dental, and vision insurance

📈 401K retirement plan with company match

🏝️ Up to 20 days of PTO per year + company holidays

👶 Up to 14 weeks of parental leave (12 for non-birthing parents)

🏡 Annual work from home stipend for remote employees

knownwell, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Based on current size of the clinic and HIPAA regulation, providers cannot receive care in clinic and provider’s household members cannot receive primary care in the clinic.