Supporting in the development, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and/or IV clinical trials research projects conducted by principal investigator(s) at the medical center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data;
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and IV clinical trials research projects conducted by principal investigator(s) at university medical center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical Trials Project Leader I's.
Recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist... in the determination of guidelines for new protocols.
Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate.
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
Conduct cross functional research team meetings as needed. Participate in conjunction with the principal investigator in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract development. Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Clinical, Project, ICF, Manager, Clinical Trials Manager, Clinical Project Manager, Budgets, Timelines, Vendor Management, Clinical Project Specialist
Top Skills Details:
Clinical Project Manager
Clinical Project Associate
Clinical Project Coordinator
Additional Skills & Qualifications:
Required Qualifications at this Level
Education/Training: Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three years of healthcare experience; or one of the following equivalents:
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