Summary of Position:

We are seeking an enthusiastic and experienced Senior Clinical Research Associate Consultant for ReCode’s RCT2100 CF program. You are a self-motivated team player that supports study team to implement clinical operations strategy for ReCode’s RCT2100 CF program. You will be responsible for collaborating with Clinical Operations and cross-functional teams to deliver on ReCode’s mission of powering the next wave of genetic medicines. You will have substantial experience in either rare diseases or genetic medicines such as mRNA, gene therapy or gene editing

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

Qualifications:

• 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

Salary Range: $50-$65/hr

*Please note that for remote positions, salary may be adjusted for cost of living