Clinical Research Coordinator

The role

The Clinical Research Coordinator oversees and coordinates all aspects of clinical trials. This role involves managing patient recruitment, data management, and ensuring compliance with regulatory requirements and GCP guidelines.

What you will do

• Coordinate and manage all aspects of clinical trials including patient recruitment, screening, and enrollment.
• Schedule and oversee patient visits and data collection.
• Oversee site initiation, monitoring, closeout activities, and equipment calibration.
• Maintain study documentation including case report forms and consent forms.
• Review monitoring follow-up letters.
• Ensure accurate and timely reporting of adverse events and serious adverse events.
• Manage receipt, shipment, and storage of study drug and trial samples.
• Serve as the main point of contact for participants.
• Assist in the informed consent process.
• Enter, maintain, and monitor study data in CTMS, EDC, and other databases.

Required qualifications

• Bachelor's degree in a related field (e.g., life sciences, nursing, healthcare)
• 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
• 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
• Ability to lift and carry study materials (up to 50 lbs)
• Ability to sit or stand for extended periods

Nice to have

• CCRC Certification
• Master's degree
• 2+ years of experience with independent trial management
• Expert phlebotomy skills

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)

Before you apply

• Candidates must be comfortable commuting to both Needham, MA and Weymouth, MA
• knownwell does not offer relocation assistance

About the company

knownwell provides weight-inclusive healthcare including weight management, primary care, nutrition counseling, and health coaching. The company's care model combines in-clinic and virtual care.