Clinical Research Coordinator

The role

You will coordinate clinical trials at knownwell, from patient recruitment and visits to data entry and regulatory compliance. You will be the main contact for participants and work with the Principal Investigator and sponsors.

What you will do

• Coordinate all aspects of clinical trials, including recruitment, screening and enrollment
• Schedule patient visits and collect data and samples per the study protocol
• Maintain study documentation, including case report forms and consent forms
• Report adverse events (AEs) and serious adverse events (SAEs) accurately and on time
• Manage receipt, shipment and storage of study drug and trial samples
• Serve as main point of contact for participants and assist with informed consent
• Enter and monitor study data in the CTMS and EDC systems
• Stay current with FDA and ICH-GCP guidelines and sponsor requirements
• Prepare IRB submissions, site materials and regulatory binders
• 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 with multiple software systems and computer technology
• Expert phlebotomy skills (strong preference)
• 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
• 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 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
• GCP, BLS, IATA and CSSR certifications are required or must be acquired if hired
• Strong preference for candidates with expert phlebotomy skills

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.