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Clinical Research Project Manager - Grants & Contracts
Location
Nevada
Posted
25 days ago
Salary
Not specified
Job Description
Job Requirements
- A caregiver in this role works remotely from 8:00 a.m. – 5:00 p.m.
- A caregiver who excels in this role will:
- Oversee the administrative functions of single and/or multi-institutional research trials.
- Coordinate/manage daily organization and operational issues/activities related to Phase I-IV clinical research trials.
- Facilitate key trial communications for academic coordination.
- Provide clinical perspective to the design and conduct of clinical trials.
- Manage and coordinate a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis.
- Interact with the Finance and Legal Departments to facilitate clinical trial budget, site budget and contract execution.
- Maintain professional relationships with sponsors, including frequent, open communication and associated documentation.
- Coordinate development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA.
- Collect and review regulatory documents from sites.
- Communicate with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues.
- Organize, coordinate, attend and participate in Investigator Meetings and training programs.
- Develop and maintain planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.).
- Analyze site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites.
- Assess investigators and site performance.
- Lead initiatives to improve quality and make recommendations to discontinue sites if necessary.
- Assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
- Complete training in Human Subjects Research (HSR) within 90 days or hire.
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