Senior Clinical Research Operations Specialist for Genetic Medicine Initiatives

3 weeks ago

Menlo Park, California, United States Lifelancer Full time
Role Summary

We are seeking an experienced Senior Clinical Research Associate Consultant to support our RCT2100 CF program. This role will collaborate with the Clinical Operations team to implement clinical operations strategies, manage trial processes, and ensure trials are initiated efficiently and completed on time.

About the Role

This is a remote position that requires a self-motivated team player who can work effectively in a cross-functional environment. The ideal candidate will have substantial experience in rare diseases or genetic medicines such as mRNA, gene therapy, or gene editing.

Key Responsibilities
  • Support the Clinical Operations Study team in managing trial processes and ensuring trials are initiated efficiently and completed on time.
  • Collaborate with the Clinical Operations and cross-functional teams to deliver on our mission of powering the next wave of genetic medicines.
  • Develop and/or assist in the development of trial materials and rare disease patient finding activities.
  • Create, monitor, and present key study performance metrics with the cross-functional team.
  • Manage key trial processes appropriately delegated by the 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 the CF Clinical Operations Program Lead and Head of Clinical Operations.
  • Develop strong and effective working relationships with the study team.
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 teams (ie CROs, imaging, home health, patient concierge, patient recruitment vendors).
  • Highly responsive and proactive team player.
  • Ability to have a 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.
Benefits

ReCode Therapeutics offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development. The estimated salary for this role is between $50-$65 per hour. As a full-time employee, you will receive 100% subsidized benefits, including company 401k contribution, 15 days of company-paid holidays, mental health support, FSA, and employee discounts.

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