- Provides leadership and oversight of significant clinical research project(s) with an emphasis on managing, evaluating and training research staff.
- Recruits, orients, and typically manages a research and administrative staff of eight to fifteen employees.
- Plans protocol, develops policies and establishes standards for the research unit.
- Develops and writes proposals for grants to conduct research.
- Manages research studies and related protocols.
- Acts as a resource person for the medical staff and community outreach.
- Develops and provides educational information and expertise in research protocol and research driven treatment modalities.
- Collaborates with others to develop and oversee effective internal quality assurance and control procedures.
- Plans and develops budgets for new protocols.
- Regularly monitors expenses and receipts for active protocols.
- Develops plans to ensure clinical research generates sufficient income to cover operating expenses.
- Demonstrates a knowledge of and competency in all regulatory requirements (FDA, GCP, ICH and HIC.)
- Submits applications and maintains Investigational New Drug (INDs) and Investigational Device Exemptions (IDEs) with the FDA.
- Responsible for regulatory compliance at every level.
- Develops and audits appropriate record-keeping procedures.
- Develops and prepares operational and statistical reports for management and regulatory agencies.
- Provides information for grant and contract applications and assists in the preparation of grants, contracts, and Requests for Proposal (RFPs).
- Performs related responsibilities as required.
- Licensed as a Registered Nurse in the state of Georgia.
- Six years clinical trials research experience which includes previous project management or leadership experience.
- Two years of supervisory or managerial experience.
- Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
- Previous grant writing experience. Knowledgeable and proficient in the use of various computer applications/systems.
- May be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents.
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