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Clinical Trial Research Nurse Manager
2 months ago
The Clinical Trial Research Nurse Manager - Operations Lead position plays a critical role in the administrative leadership and direction of the operational aspects of a large and/or multiple regional clinical trials program. This position oversees clinical trial research activities of non-physician research personnel in a manner that effectively maximizes quality and compliance with clinical research standards, participant safety, and staff satisfaction.
Key Responsibilities:- Assists in the daily operations of research units at multiple locations, ensuring seamless coordination and effective communication among team members.
- Under the direction of clinical trials administrative management, interprets policies and implements procedures for the program, ensuring compliance with KP HealthPlan and governmental agencies.
- Prepares for audits and inspections by internal and external auditors, including coordination of the development of corrective action plans and follow-up.
- Provides support during internal and external audits, ensuring audit readiness and identifying areas for improvement.
- Collaborates with Principal Investigators (PIs) and Sponsors in establishing, implementing, and conducting clinical trials, ensuring alignment with organizational goals and objectives.
- Develops and manages budgets, ensuring effective resource allocation and financial management.
- Evaluates potential protocols to determine feasibility, resource requirements, and potential risks, ensuring informed decision-making.
- Establishes and maintains effective partnerships with stakeholders, including PI, Sponsor, and research staff, to ensure region-wide communication and coordination of the clinical trials program.
- Serves as a mentor and content expert to research staff, providing guidance and support to ensure successful project execution.
- Resolves complex operational and personnel issues, ensuring timely and effective resolution.
- Assists licensed and non-licensed research staff to effectively maximize quality and compliance with clinical research standards, participant safety, and staff and member satisfaction.
- Identifies training needs, develops materials, and coordinates training to ensure research staff have the necessary skills and knowledge to perform their duties effectively.
- Collaboratively develops strategies and implements protocol-specific operating procedures to improve the quality of research and patient care.
- Assists in developing and implementing departmental policies and procedures, ensuring alignment with organizational goals and objectives.
- Assists in the development of clinical trials technology systems and infrastructure, ensuring effective integration and utilization.
- Recruits and hires new clinical research staff, ensuring a skilled and diverse team.
- Effectively manages staff, budget, resource/allocation planning, and performance assessments for a variety of clinical, regulatory, and research functions.
- Minimum five (5) years of clinical nursing experience in a hospital, clinic, or similar healthcare setting required.
- Minimum three (3) years of supervisory experience in a hospital, clinic, or similar setting required.
- Minimum three (3) years of clinical trials research experience preferred.
- Minimum four (4) years of effective project management, analytical problem-solving, and negotiating experience.
- Current IATA/DOT certification preferred.
- Bachelor's degree preferred.
