Clinical Research Coordinator

The role

You will coordinate all aspects of clinical trials, including patient recruitment, screening, enrollment, visits and study records. You will be the main contact for participants, help with informed consent, and keep the study compliant with FDA, ICH-GCP and sponsor requirements.

What you will do

• Coordinate clinical trials, including patient recruitment, screening and enrollment
• Schedule patient visits and ensure timely data and sample collection per protocol
• Oversee site initiation, monitoring, closeout and equipment calibration
• Maintain study documents such as case report forms and consent forms
• Report adverse events and serious adverse events accurately and on time
• Manage receipt, shipment and storage of study drug and samples
• Serve as main point of contact for participants and help with informed consent
• Enter, maintain and check study data in the CTMS and EDC systems
• Prepare regulatory documents and submissions to the IRB
• Train study staff on regulatory requirements and protocols

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 acquire 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 lift and carry study materials up to 50 lbs
• Ability to sit or stand for extended periods

Nice to have

• CCRC certification or master's degree
• 2+ years of experience with independent trial management
• Expert phlebotomy skills
• Proficiency in phlebotomy, EKG administration and vital sign assessment

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

About the company

knownwell offers weight-inclusive healthcare, including weight management, primary care, nutrition counseling and health coaching. It combines in-clinic and virtual care and is backed by $50M in funding.