Great Lakes Research Institute, LLC, is looking for an experienced Site Director to join our leadership team.
Training and Clinical Research Knowledge
1. Complete required training, including GCP, IATA and any other relevant training requirements.
2. Maintain working knowledge of current FDA regulations, ICH/GCP guidelines, organizational SOPs, site related process documents, guidance documents and study protocols
Clinical Research Management
3. Responsible for managing a clinical research
team – Clinical Research Coordinators, Regulatory Coordinators, Phlebotomists, Patient Recruiters, etc.
4. Responsible for ensuring subject safety, data integrity, improving quality metrics, clinical trial data metrics, and risk management of clinical trial projects across assigned sites
5. Responsible for maintaining effective sponsor/CRO relationships, external vendor relationships
6. Responsible for effective cross functional collaboration for successful execution of clinical trial projects at assigned sites
7. Provide subject matter expertise on planning for subject enrollment strategies, and collaborate with cross functional teams to ensure subject enrollment goals are met. Understanding of RippleScience’s recruitment and patient registry is a plus.
8. Responsible for planning and implementing strategic priorities
9. Ensure site audit readiness. Provide strategic oversight and subject matter expertise for audit preparedness and during audits and inspections.
Staffing and Employee Development
10. Identify training/mentoring needs, and create strategies, road map for employee growth, employee development and internal promotions Reporting Clinical Trial Performance Management Metrics to senior management on a regular basis.
Managing Patient Visits/ and Site Management
11. Coordinating duties when necessary. This includes unblinded tasks such as mixing IP and blinded tasks such as conducting a patient visit.
12. Ensure data is entered from Source to EDC in a timely basis.
13. Ensure queries are responded to on a timely basis.
Any other tasks delegated by the senior management team.