Job Description
Responsibilities:
- Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, enrollment, study maintenance, and close-out.
- Assist with the development, oversight, and/or completion of the clinical documents including, but not limited to:
- Clinical study protocol
- Informed consent form template (master and/or country-level)
- Cell therapy product procedure manual and related forms
- Clinical monitoring/management plan including report templates
- Training slides and materials (e.g., SIV slides, protocol training materials)
- Investigator Site File (ISF) structure and template documents
- Others as needed study-specific documents, plans, charters, tools, trackers, etc. (including that of the CRO)
- Contributor and reviewer of the clinical documents below:
- Clinical laboratory manual and requisition forms
- CRFs and CRF completion guidelines
- Interactive Response Technology (IRT) manual (e.g., IVRS, IWRS, IXRS)
- Central imaging manual
- Edit check / data review plan
- Data review board charter (e.g., DSMB, SRC)
- Safety management plan and SAE report form template
- Manage and/or support the Manager, Clinical Operations with oversight of the Trial Master File (TMF). Responsibilities include, but not limited to:
- Filing clinical documents in the Trial Master File (TMF)
- Assisting with the development, oversight, and/or completion of the TMF index and TMF management plan.
- Periodically reviewing the TMF for reconciliation and QC, following up with the clinical sites, clinical trial monitors, and/or vendors to close-out TMF-related issues.
- Support the Manager, Clinical Operations with various meetings, may include assisting in developing meeting agendas, writing meeting minutes, and facilitating review of minutes:
- Internal study team meeting
- Other internal clinical operations meetings
- Working group meetings
- CRO/vendor meetings
- Support the Manager, Clinical Operations in the selection process of vendors and/or contractors supporting a study, including but not limited to:
- CRO
- Clinical trial monitors
- Central lab
- Central imaging
- EDC system
- IRT system
- Support the Manager, Clinical Operations in overseeing, managing, and tracking performance of assigned vendors selected for a clinical study which could include acting as a point of contact as delegated by the manager, facilitating review of vendor study specific documents, tracking performance indicators for vendors, creating and maintaining a vendor-specific issues log.
- Ensures documentation of training for internal study team, vendors, third party contractors, and sites.
- Help manage, oversee, and track performance of clinical sites selected for a clinical study, which could include acting a point of contact for the sites.
- Facilitate sponsor review and approval of site-specific documents (e.g., site-specific ICF, patient facing materials, etc.).
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Participate in the development, review and implementation of departmental SOPs and processes.
- Contribute to the selection of contractors or FTEs that join the company
- Other duties as assigned.
- Minimum requirement of a BA/BS or equivalent degree, plus 1-2 years of direct experience in clinical operations supporting clinical drug development within the oncology and/or cell therapy space; OR minimum 3 years of direct experience in clinical operations supporting clinical drug development with no experience in oncology and/or cell therapy clinical studies.
- Experience and/or knowledge of transplant patient care and apheresis collection for Clinical Trials strongly preferred.
- Experience participating in the selecting and managing of CROs and other clinical trial vendors (e.g., central lab, central imaging, etc.)
- Knowledge and understanding of ICH guidelines, GxPs for conduct of Clinical Trials, and FDA and EMA regulations.
- Outstanding organizational skills with the ability to multi-task and prioritize.