Hybrid Clinical Trials Coordinator: Obesity Research

knownwell; United States; Hybride; USD 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Hybrid Opportunity

Medical, dental, and vision insurance

401K retirement plan with company map

Up to 20 days of PTO per year + bank

Up to 14 weeks of parental leave

Annual work from home stipend

Résumé du poste

knownwell, Inc. is hiring a Clinical Research Coordinator in the Greater Boston Area, Needham and Woburn. The CRC will oversee all aspects of clinical trials, ensure GCP compliance, and coordinate between the research team, patients, and sponsors.

The role includes patient recruitment, visit scheduling, data management in CTMS/EDC, regulatory submissions, and training study staff. On-site with hybrid flexibility and strong emphasis on safety and quality.

Qualifications

• Bachelor’s degree required in life sciences, nursing, or related field.
• CCRC certification and/or master’s degree preferred.
• 3+ years in clinical research; 2+ years independent trial management preferred.
• GCP, BLS, IATA, and CSSR certifications or willingness to obtain.
• Experience with multiple software systems.

Responsabilités

• Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment.
• Schedule and oversee patient visits, ensuring timely collection of data and samples.
• Oversee site initiation, monitoring, closeout activities, and equipment calibration.
• Maintain study documentation, including case report forms and consent forms.
• Review monitoring letters and ensure timely completion of issues.
• Ensure accurate reporting of adverse events (AEs) and serious adverse events (SAEs).
• Manage receipt, shipment, and storage of study drug and samples.
• Generate invoices for study sponsors as applicable.
• Serve as the main point of contact for participants and assist with informed consent.

Connaissances

Phlebotomy

Leadership

Time management

Communication

Independent work

Teamwork

Formation

Bachelor’s degree in life sciences or related field

CCRC Certification

Master’s degree preferred

GCP, BLS, IATA, and CSSR certifications

Outils

CTMS

EDC

Description du poste

knownwell, Inc. is hiring a Clinical Research Coordinator in the Greater Boston Area, Needham and Woburn. The CRC will oversee all aspects of clinical trials, ensure GCP compliance, and coordinate between the research team, patients, and sponsors.

The role includes patient recruitment, visit scheduling, data management in CTMS/EDC, regulatory submissions, and training study staff. On-site with hybrid flexibility and strong emphasis on safety and quality.