Responsible for operational aspects of planning and management of site performance in accordance with departmental expectations. May act as primary liaison between in-house CRAs, field based CRAs, Cooperative Group or Network contacts, and the Clinical Project Manager (CPM). Supports and assists Clinical Project Managers in operationalizing multiple clinical research studies.
- Under supervision may participate/lead in CRA project-specific training.
- Supports preparation and development of materials related to the training and presentations for Investigator Meetings.
- Facilitates CRA project meetings.
- Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct to the appropriate study CPM.
- Track and report on progress of the study metrics, including site activation, patient enrollment and monitoring visits.
- Ensures that all sites are provided supplies in accordance with study expectations.
- Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with the CPM.
- Develop PSV /SIV/IMV presentation and other training tools and training materials in support of the project.
- May be responsible for ensuring that monitoring visits are performed in accordance with the protocol, monitoring plan, and applicable Karyopharm SOPs.
- Under supervision may be responsible for operationalizing clinical protocols at the site level and ensuring appropriate SOPs are being followed for each process, depending on the study
- May participate in eCRF User Acceptance Testing (UAT) and the creation of eCRF completion guidelines and ensuring site level access to eCRFs throughout the conduct of a study.
- Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team.
- Work with Lead CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol and regulations.
- Liaise with Lead CRA regarding data entry/data quality concerns and alert them of any issues prior to the next scheduled monitoring visit.
- Assist with study start-up activities including development of the first draft of the ICF.
- Assist with the review of protocol, protocol amendments, ICF and CSR documents as required.
- Agenda distribution & minute taking for internal study team meetings.
- Up to 20% domestic and/or international travel may be required.