Job Summary: The Clinical Trial Nurse Manager (CTN-Manager) position assists 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. Essential Responsibilities: Assists in the daily operations of research units at multiple locations. Under the direction of clinical trials administrative management, interprets policies and implement procedures for the program, ensure 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 Provide support during internal and external audits. Assure audit readiness. Collaborates with PI and Sponsor in establishing, implementing, and conducting clinical trials Develop budgets Evaluate potential protocols to determine feasibility, resource requirements, etc. Establishes and maintains effective partnerships to ensure region-wide communication and coordination of the clinical trials program, fostering teamwork Serve as a mentor and content expert to research staff. Resolve complex operational and personnel issues. Assists licensed and non-licensed research staff to effectively maximizes quality and compliance with clinical research standards, participant safety, and staff and member satisfaction. Identify training needs, develop materials and coordinate training. Collaboratively develops strategies and implement protocol-specific operating procedures to improve the quality of research and patient care. Assist in developing and implementing departmental policies and procedures. Assist in development of clinical trials technology systems and infrastructure. Recruits and hires new clinical research staff. Effectively manage staff, budget, resource/allocation planning, and performance assessments for a variety of clinical, regulatory and research functions. Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees. Basic Qualifications: Experience Minimum five (5) years of clinical nursing experience in a hospital, clinic or similar health care setting required. Minimum three (3) years of supervisory experience in a hospital, clinic or similar setting required. Education Diploma from an accredited nursing school required. High School Diploma or General Education Development (GED) required. License, Certification, Registration Registered Nurse License (California) Basic Life Support Additional Requirements: Experience in outpatient and/or inpatient clinical environment, clinical trial regulatory and data submission requirements. Ability to analyze research protocols and KP and KFRI policies and procedures with respect to implementation and medical, nursing, fiscal, compliance, quality, and risk management aspects. In-depth working knowledge of nurse practice act, GCP, federal, state, and local regulations including HIPAA and KP policies and procedures. Knowledge of and experience in outpatient and/or inpatient clinical environment, clinical trial regulatory and data submission requirements. Effective written oral and written communications skills Ability to work independently Ability to work on teams, and assigned committees Ability to work in a designated management structure Ability to work in a Labor Partnership environment Must be able to work in a Labor/Management Partnership environment. Certification in one or more therapeutic areas required. Willingness to obtain other certifications, if 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. Current IATA/DOT certification preferred. Bachelors degree preferred.
