Senior Clinical Trial Associate

4 weeks ago

Menlo Park, California, United States ReCode Therapeutics, Inc Full time
About ReCode Therapeutics

ReCode Therapeutics is a clinical-stage genetic medicines company dedicated to harnessing the power of precision delivery to revolutionize the treatment of rare and common genetic diseases. Our proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues, and cells implicated in disease, resulting in improved efficacy and potency.

Job Summary

We are seeking an experienced and dynamic Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of our clinical trials across multiple programs. Your expertise in clinical operations, combined with your passion for delivering high-quality results, will be essential in driving the success of our programs.

Responsibilities
  • Provide administrative support to the Clinical Operations Department, ensuring seamless execution of clinical trials.
  • Collaborate with cross-functional teams to deliver on ReCode's mission of powering the next wave of genetic medicines.
  • Develop and maintain various study trackers, including patient trackers and Form FDA 1572 trackers.
  • Facilitate study team meetings, including scheduling, preparing agendas, and maintaining archives.
  • Support eTMF process in partnership with functional groups and CROs.
  • 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.
What We Offer
  • Competitive compensation and benefits package.
  • Opportunity to work with a dynamic and collaborative team.
  • Professional growth and development opportunities.
  • Flexible work arrangements, including remote work options.

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