Knownwell
Clinical Research Coordinator
Boston, MA
No sponsorshipDetected 62 days ago
GCPComplianceHIPAAClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationGxP
About the role
- 👋 Meet knownwell https://www.knownwell.co/, weight-inclusive healthcare for all.
- Join a dynamic company that is changing the way obesity care is delivered.
- The CRC will act as the primary liaison between the clinical research team, patients, and external stakeholders, ensuring the efficient and timely execution of clinical research projects.
Responsibilities
- Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment.
- Maintain study documentation, including case report forms, consent forms, and other essential study records.
- Manage the receipt, shipment, and storage of study drug and trial samples.
- 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.
- 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.
- Maintain regulatory binders and drug accountability documents for each study.
Requirements
- Proficiency in using multiple software systems and computer technology (preference for experience with Florence, Advarra and Greenphire).
- Archive all documentation at the end of the study per Sponsor and FDA-required timelines.
Nice to have
- 3+ years of experience in clinical research and industry environments.
- 2+ years of experience with independent trial management preferred.
Skills
- Strong organizational, leadership, and time-management skills.
- Excellent written and verbal communication skills.
- Experience working on collaborative, diverse, and feedback-driven teams.
- Proven history of adapting and thriving through periods of change.
- Pay & Perks:
- 🏠🏢 Hybrid Opportunity
- 🩺 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
Compensation
- 🏝️ Up to 20 days of PTO per year + company holidays
Benefits
- We offer weight management, primary care, nutrition counseling, and health coaching.
- Ensure patients understand the study's risks, benefits, and requirements by assisting in the informed consent process.
Visa & Work Authorization
- inating all aspects of clinical trials, ensuring that studies are conducted in compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines
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This listing is sourced directly from Knownwell's careers page and normalized into a canonical job model.