Position: Coordinator, Clinical Biomarker Operations (CBO)
Company: Repare Therapeutics
Location: Cambridge, Massachusetts, USA
Website: http://www.reparerx.com/
Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.
Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.
We are seeking a Coordinator, CBO with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. This individual will coordinate with translational researchers, clinical operations and PK team members in order to implement and maintain biomarker and clinical sample operational plans. This position requires a combination of scientific and project management expertise as they will be responsible for the support of clinical laboratory functions within clinical trials; Includes operational support for biomarker definition and selection, clinical testing schedules, and lab manual creation.
Responsibilities:
- Manage end-to-end sample tracking and logistics for clinical samples, working closely with the central and specialty lab vendors as well as a sample and data management vendor
- Identify, triage, and resolve biomarker sample queries to ensure sample and data integrity
- Monitor trends and quality metrics as they relate to clinical site sample collection, processing and shipment errors
- Ensure biomarker laboratory documents are filed appropriately in the eTMF
- Maintain biomarker documentation (requisition forms, analysis request forms, redacted patient files, etc.) in an organized manner
- Assist with creating site and team training tools as they relate to clinical biomarker operations
- Liaise with the preclinical teams to help drive translational research projects and ensure timely data delivery
Qualifications:
- Bachelor’s degree with Science focus
- Experience managing clinical labs study startup and oversight
- 1-3 years experience in clinical operations with a focus on clinical laboratory management
- Strong verbal and written communication skills
- Excellent interpersonal and organizational skills
- Ability to deal with competing priorities
- Strong reasoning, detail orientation and problem-solving abilities are essential
- Ability to work on teams and on multiple concurrent projects, and works well under general direction with tight timelines