The primary role of the Translational Medicine Operations (TM Ops) group at Gritstone Oncology is to provide clinical bio specimen management and logistics support to the various global oncology programs under clinical development. TM Ops reports into the Clinical Operations function at Gritstone Oncology.
The TM Ops Specialist II/III will have a background in biotech/pharma or research/healthcare, and will have some experience in matters related to biobanking and specimen acquisition. This function will work closely with Research teams as well as Manufacturing and Quality Assurance (QA) personnel. Essential job functions include:
- Receive and log delivery of bio specimens daily.
- Receive and log delivery of specimens intended for manufacturing use in accordance with GMP and company SOPs.
- Inspect and verify contents of packages for specimen quality, appropriate shipping temperature and conditions, and data accuracy, communicate discrepancies to internal clinical operations, QA and manufacturing personnel and external clinical sites.
- Document, track and resolve specimen related discrepancies.
- Quarantine specimens intended for manufacturing use pending Quality inspection in accordance with company SOPs.
- Assist with the set-up and implementation of the bio specimen storage system.
- Enter/upload specimen related data into the appropriate specimen tracking and storage system.
- May perform some basic specimen processing on request.
- Retrieve clinical specimens from storage in accordance with relevant Research protocols, as requested by Research teams.
- Assist Research teams with specimen storage management and maintenance.
- Route samples into the appropriate workflow(s) and ensure downstream laboratory staff is notified of specimen availability.
- File specimen source documents, query resolutions, and other specimen related documentation in accordance with company policy.
- Track specimen chain of custody in accordance with company SOPS.
- Ship specimens to external hospitals/clinics or scientific collaborators per IATA regulations and guidelines. This includes generating specimen shipment manifests, providing shipment notifications and confirming specimen delivery.
- Perform specimen data reconciliation and discrepancy resolution. Resolve specimen related issues with study sites and/or vendors.
- Generate specimen management reports. May analyze study/project level specimen management metrics and identify trends/issues for team discussion.
- May assist with the review of clinical protocols, informed consent documents and Case Report Forms (CRFs) as it relates to specimen collection and logistics.
- Perform a quality check on TM Ops authored documents (training slides, laboratory manuals, study aids, bio specimen management plans, etc.). May provide input into the development of TM Ops documents.
- Assist with management of TM Ops specimen vendors. Tasks may include: managing day to day vendor activities, managing vendor relationships, reviewing and negotiating vendor SOW/specifications/budgets for study setup, developing requests for proposals (RFPs), tracking vendor expenses against vendor contracts, and assisting in review of study invoices.
- Maintain the shared electronic departmental workspace.
- Follow established company SOPS for specimen handling, including GMP SOPs.
- Participate in departmental meetings.
- Participate in special projects and/or assignments as requested by Manager/Director.
- BA/BS or equivalent degree in a scientific or healthcare related field.
- 2+ years pharmaceutical/biotech industry experience.
- IATA training certification a plus.
- Some biobanking and/or specimen acquisition experience is preferred.
- Prior experience in a clinical laboratory setting or other health related field is preferred.
- Experience working in a GMP regulated environment is a plus.
- Strong organizational skills and attention to detail.
- Must be meticulous and thorough.
- Able to work effectively in a fast paced, small start-up company.
- Able to function independently as well as part of a team.
- Good written/verbal communication skills.
- Excellent interpersonal skills. Customer-service oriented.
- Proficient in Microsoft Office.
- Basic knowledge of GMP, GCP, ICH and general FDA guidelines.
- Familiarity with laboratory information management systems/web-based specimen management software.
- Familiarity with clinical study management systems (IVRx, EDC, etc.), preferred.
- Familiarity with Good Documentation Practices (GDP) is a plus