Clinical Trials Research Nurse Manager

7 hours ago

American Canyon, California, United States Kaiser Permanente Full time
Job Summary:
The Clinical Trials Research Nurse Manager position plays a crucial 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.
  • 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 compliance.
  • Collaborates with PI and Sponsor in establishing, implementing, and conducting clinical trials, fostering a culture of teamwork and collaboration.
  • Develops budgets and evaluates potential protocols to determine feasibility, resource requirements, and other critical factors.
  • Establishes and maintains effective partnerships to ensure region-wide communication and coordination of the clinical trials program, promoting a culture of excellence.
  • Serves as a mentor and content expert to research staff, providing guidance and support to ensure success.
  • 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 are equipped with the necessary skills and knowledge.
  • 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 KP's mission and values.
  • Assists in development of clinical trials technology systems and infrastructure, ensuring seamless integration and effective use.
  • Recruits and hires new clinical research staff, ensuring a diverse and talented team.
  • Effectively manages staff, budget, resource/allocation planning, and performance assessments for a variety of clinical, regulatory, and research functions.
Requirements:
  • 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.
Preferred Qualifications:
  • Minimum three (3) years of clinical trials research experience preferred.
  • Minimum four (4) years of effective project management, analytical problem-solving, and negotiating experience preferred.
  • Current IATA/DOT certification preferred.
  • Bachelor's degree preferred.

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