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 Functions:
- 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 maximize quality and compliance with clinical research standards, participant safety, 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, performance assessments for a variety of clinical, regulatory and research functions.
Secondary Functions:
Collaborates with principal investigators and sponsors in establishing, implementing and conducting clinical research trials which test the safety, efficacy and toxicity of experimental drugs, vaccines, and devices on KFHP members. Manages the operations of research units at multiple locations. Supervises research staff, assesses their needs, and identifies educational opportunities. Recruits and hires new clinical research staff. Develops training materials and takes responsibility for training of new hires. Directs and designs quality assurance programs for clinical trials. Collaborates in the management of research data. Implements quality assurance programs and develops strategies which improve the quality of research conducted and patient care. Delvelops and presents quality assurance training programs. Responsibilities for performance evaluations of the research staff. Counsels and disciplines staff members who are non-compliant with applicable policies, procedures, and standards. Manages and resolves human resource, employee, and department issues. Performs as a point person for decision-making and problem solving day to day operation of projects, including the resolution of technical problems and questions of research staff. Acts as patient advocate resolving patient care issues. Designs and evaluates processes to improve systems and patient outcomes across the continuum of care. Participates in design and development of overall clinical plans for the conduction of multiple clinical trials. Develops and implements protocol specific standard operating procedures. Determines and monitors budgets for the appropriate use of human and material resources. Monitors financial performance. Identifies and implements strategies to reduce cost and improve quality. Ensures compliance with KFHP, Nursing Practice Act, federal, state, local and other (JCAHO) regulatory requirements which govern the testing of investigational drugs and vaccines. Travel to other sites as needed. Attend National Research meetings as needed. This job is in adult oncology. Home base is in Santa Clara.
Qualifications:
Basic Qualifications:
- 5 years clinical nursing experience in a hospital, clinic or similar health care setting required.
- 10 years clinical trials research experience required.
- 3 years of recent and effective supervisory experience in a hospital, clinic or similar health care setting required.
- 4 years effective project management, analytical problem solving and negotiating experience required.
- Bachelor's degree preferred and may be substituted for 5 years clinical trials work experience.
- Master's degree may be substituted for 6 years clinical trials work experience.
- Diploma from an accredited nursing school required.
- Current CA RN license required.
- Certification in one or more therapeutic areas required
- Current IATA/DOT certification required.
- Current ACRP or SoCRA certification required.
- Current BLS certification required
- Willingness to obtain other certifications, if required.
- Ability to analyze research protocols, 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.
- Ability to work in a Labor Partnership environment.
Preferred Qualifications:
-Significant experience (usually 5+ years) in a research/health care environment to include management and supervisory responsibility; the development of research procedures to support the research design/principles of a particular project; and in-patient and out-patient care experience.
- Excellent project management, written and oral communications, and statistical analysis skills.
- Directs, coordinates, leads, and facilities multiple research trials, sites, and multi-disciplinary clinical research staff in the testing and evaluation of investigational drugs and vaccines.
- Works directly with the sponsors and investigators.
- Develops and maintains good clinical practice standards, budgets and staff development programs.
- Participates in the research contract acquisition process.
- Ensures compliance with organizational and government regulatory standards.
++ NOTE:Travel to other sites as needed. Attend National Research meetings as needed. This job is in adult oncology. Home base is in Santa Clara.++
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.