Senior Clinical Trial Associate

7 days ago

Menlo Park, California, United States ReCode Therapeutics, Inc Full time
Job Title: Senior Clinical Trial Associate

We are seeking a highly motivated and experienced Senior Clinical Trial Associate to join our team at ReCode Therapeutics, Inc. As a key member of our Clinical Operations Department, you will play a critical role in supporting the execution of our clinical trials across multiple programs.

Responsibilities:
  • Provide administrative support to the Clinical Operations Department, ensuring seamless day-to-day operations.
  • Collaborate with cross-functional teams to deliver high-quality clinical trials, leveraging your expertise in rare diseases and genetic medicines.
  • Support study start-up activities, including site management, vendor coordination, and regulatory submissions.
  • Develop and maintain study trackers, ensuring accurate and timely data management.
  • Facilitate study team meetings, preparing agendas, minutes, and maintaining archives.
  • Support eTMF process, working closely with functional groups and CROs to ensure compliance.
  • Manage sample management processes, ensuring efficient and accurate sample handling.
  • Coordinate and manage study communications, including study newsletters and updates.
  • Manage access to systems for CROs, vendors, and team members.
  • Maintain systems to monitor study metrics and overall study information.
Qualifications:
  • BS/BA required
  • 2-3+ years of Clinical Operations experience in the biotech/pharma industries
  • Rare disease/orphan drug experience a plus
  • Clinical Operations experience across multiple phases of development from Phase 1-3
  • Strong working knowledge of ICH/GCP guidelines and thorough knowledge of clinical monitoring procedures
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team
  • Highly responsive and proactive team player
  • Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously
  • Excellent oral and written communication skills
  • Champion for change within a fast-growing company/department
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

ReCode Therapeutics, Inc. is an Equal Opportunity Employer.

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