Clinical Research Coordinator

The role

You will coordinate and manage clinical trials, from patient recruitment and enrollment through visits, data and sample handling. You will be the main contact for participants and keep the study compliant with FDA, ICH-GCP and sponsor rules.

What you will do

• Coordinate all aspects of clinical trials, including patient recruitment, screening and enrollment.
• Schedule and oversee patient visits and ensure timely data and sample collection per protocol.
• Maintain study documentation such as case report forms, consent forms and regulatory records.
• Report adverse events (AEs) and serious adverse events (SAEs) accurately and on time.
• Manage receipt, shipment and storage of study drug and trial samples.
• Assist participants with informed consent and monitor their progress and safety.
• Enter and monitor study data in the CTMS and EDC systems and run quality control checks.
• Prepare IRB submissions, protocols, amendments and site training materials.
• Train study staff on regulatory requirements and protocol compliance.
• Archive study documentation at the end of the study per sponsor and FDA timelines.

Required qualifications

• Bachelor's degree in a related field such as life sciences, nursing or healthcare.
• GCP, BLS, IATA and CSSR certifications, or willingness to obtain them if hired.
• 3+ years of experience in clinical research and industry environments.
• Solid understanding of drug development, FDA and ICH GCP guidelines.
• Proficiency in 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.
• Ability to lift and carry study materials up to 50 lbs.
• Ability to sit or stand for extended periods.

Nice to have

• CCRC certification and/or a master's degree.
• 2+ years of experience with independent trial management.
• Expert phlebotomy skills.
• Experience working on collaborative, diverse and feedback-driven teams.

Benefits

• Medical, dental and vision insurance.
• 401K retirement plan with company match.
• Up to 20 days of PTO per year plus company holidays.
• Up to 14 weeks of parental leave (12 for non-birthing parents).
• Annual work from home stipend for remote employees.

Before you apply

• knownwell does not offer relocation assistance.
• Phlebotomy, EKG administration and vital sign assessment are part of the role.

About the company

knownwell provides weight-inclusive healthcare, including weight management, primary care, nutrition counseling and health coaching, combining in-clinic and virtual care. It is backed by $50M in funding, including a $25M round led by CVS Health Ventures.