Description
Principal Responsibilities:- Act as primary liaison to CROs and vendors for assigned clinical study programs, ensuring adherence to project scope, deliverables and timelines
- Facilitate study start up with CROs and clinical sites
- Organize and run assigned clinical study team meetings and teleconferences
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
- Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD/ADA) data, data cleaning status for assigned clinical study/program, etc.
- May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff
- Monitor the maintenance of the clinical trial master files per SOPs and GCP, at the CRO(s) and vendors.
- Assist in the development of clinical project timelines to meet critical company milestones
- Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, investigator brochure, clinical study reports, INDs/CTAs, marketing applications, annual regulatory reports, etc.
- Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned clinical study/program
- Assess feasibility for assigned clinical studies and contribute to the investigator/site selection process
- Assist in the development, forecasting, monitoring, and reporting of assigned clinical study/program budgets
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Contribute to the writing and implementation of Standard Operating Procedures (SOPs), standard forms and study-specific guidelines to support clinical operations