knownwell · 14 hours ago
Clinical Research Coordinator (Multi-Site)
Boston, MA
Part-time
Hybrid
Mid, Senior Level
3+ years expKnownwell is a dynamic company focused on changing the way obesity care is delivered through weight management, primary care, nutrition counseling, and health coaching. The Clinical Research Coordinator (CRC) will oversee and coordinate all aspects of clinical trials, ensuring compliance with regulatory requirements and acting as the primary liaison between the research team, patients, and external stakeholders.
Artificial Intelligence (AI)Health CareMedicalPrimary and Urgent Care
Responsibilities
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
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
Enter, maintain, and monitor study data in the clinical trial management system (CTMS) 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
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
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
Qualification
Required
Bachelor's degree in a related field (e.g., life sciences, nursing, healthcare)
CCRC Certification
GCP, BLS, IATA, and CSSR Certifications (or willingness to acquire if hired)
3+ years of experience in clinical research and industry environments
Solid understanding of drug development processes, FDA, and ICH GCP guidelines
Proficiency in using multiple software systems and computer technology (preference for experience with Florence, Advarra and Greenphire)
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
Preferred
Master's degree
2+ years of experience with independent trial management
Benefits
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
Company
knownwell
Knownwell is a plug-and-play platform designed to consolidate data from various sources.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$50.57MKey Investors
CVS Health VenturesAndreessen HorowitzFlare Capital Partners
2025-10-20Series B· $26.07M
2023-12-19Series A· $20M
2023-01-19Seed· $4.5M
Leadership Team
Brooke Pratt
Chief Executive Officer, Founder
Angela Fitch
Chief Medical Officer
Recent News
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