Remote Senior Clinical Research Associate Consultant

Summary

Join ReCode Therapeutics as a Senior Clinical Research Associate Consultant to support the RCT2100 CF program, collaborating with cross-functional teams to deliver clinical operations strategy and leveraging experience in rare diseases or genetic medicines.

Requirements

• BS/BA required with 4+ years of Clinical Operations experience in biotech/pharma across Phase 1-3 clinical trials
• Rare disease/orphan drug experience preferred
• Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures
• Understanding of core clinical trial vendors with previous experience supporting study team (ie CROs, imaging, home health, patient concierge, patient recruitment vendors)
• Highly responsive and proactive team player
• Ability to have growth mindset when problem solving complex issues
• Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously
• Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment
• Ability to think creatively and come up with unique solutions for rare disease programs
• Champion for change within a fast-growing company/department

Responsibilities

• Support CF RCT2100 Clinical Operations Study team in managing to ensure trials are initiated efficiently and completed on time
• Support CRO activities, including site feasibility and qualification, study initiation, interim monitoring
• Develop and/or assist in the development of trial materials and rare disease patient finding activities
• Work closely with CF Clinical Operations Program Lead and provide training to CRO and study site staff
• Create, monitor, and present key study performance metrics with cross-functional team
• Manage key trial processes appropriately delegated by Clinical Operations Study team
• Review data listings for accuracy, oversee data discrepancy management, and perform associated training/retraining to site staff and CRAs as needed
• Liaise with CRO/vendors to manage start-up activities at trial sites including ethics submissions
• Escalate any issues in a timely manner to CF Clinical Operations Program Lead and Head of Clinical Operations
• Develop strong and effective working relationships with study team
• Ability to travel for periodic site initiation visits, and co-monitoring visits
• Build relationships with clinical trial sites as delegated by Clinical Operations Study team

Benefits

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots