Clinical Trials Associate
2 weeks ago
Pay Rate: $60-90/hour depending on experience
This position will be REMOTE with occasional in-person meetings. All business related travel, hotel, and meals will be reimbursed.
Summary:The Clinical Trials Associate with Oncology/Cell-Therapy experience will work in-house and will support the Manager, Clinical Operations in the conduct of clinical trials sponsored by the company. This individual will have responsibilities for aspects of the clinical trial to assist with study start-up, enrollment, maintenance, and close-out.
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.
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