SENIOR CLINICAL TRIAL ASSOCIATE, CLINICAL OPERATIONS

3 weeks ago

CA United States BioSpace Full time
Job Details

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's 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, enabling improved efficacy and potency. ReCode's lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

Summary of Position:

The Senior Clinical Trial Associate (Contract) will report to the Clinical Operations Program Lead. You are a team player that will execute US and global clinical operations strategy for ReCode's programs. You will be responsible for collaborating with our cross-functional teams to deliver on ReCode's mission of powering the next wave of genetic medicines. You will have experience in either rare diseases or genetic medicines such as mRNA, gene therapy or gene editing.

This is a contract position for 40 hours/week.

Responsibilities:
  • Manage eTMF process end to end in partnership with functional groups and CROs
  • Provide administrative support to the Clinical Operations Department.
  • Serve as a primary point of contact for project-related communications, managing correspondence and associated documents, and coordinate updates to distribution lists for sites, CROs, and vendors.
  • Develop and maintain various study trackers (e.g. Patient trackers and Form FDA 1572 tracker).
  • Facilitate study team meetings (i.e. SET), including scheduling, preparing agendas and minutes, and maintaining archives.
  • Coordinate and manage study communications, including newsletters and updates.
  • Support study start-up activities, including assigning site numbers and reviewing regulatory packets.
  • Manage access to systems for CROs, vendors, and team members.
  • Maintain systems to monitor study metrics and overall study information.
  • Attend necessary study, project, and departmental meetings.

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 all phases of development from Phase 1-3 with emphasis on early phase development
  • 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

Salary Range: *$65-$80/hr

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

Benefits Offered for Full-Time Employees:
  • 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 (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.

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