Job Summary:
The Clinical Research Support Services (CRSS) Manager has responsibility for managing a research clinical trials department. The Manager oversees and coordinates clinical research trials and the multi-disciplinary research team in testing and evaluation of interventions, investigational drugs, biologics and devices. Works directly with sponsors and investigators. The Manager has oversight of project budget development, appropriate staffing resources and compliance with organizational SOPs and government regulations for the conduct of research with human subjects.
Essential Responsibilities:
- Collaborates with CHR and/or KPNW principal investigators, study sponsors, CHR department and regional leads and appropriate regional leaders, in establishing, implementing and conducting clinical research trials within departmental area. Evaluates and determines feasibility of research studies based on capacity and appropriate and adequate resources in collaboration with principal investigator and Sr. Manager of Clinical Research Support Services.
- Manages budget preparation as well as ongoing revenue and expenses of designated portfolio for industry and federally funded projects. Proactively monitors trial budgets for appropriate use of resources and effective management of those resources within study budgets. Collaborates with KFRI legal to ensure sponsor contracts provide alignment with clinical trial operations.
- Manages clinical research compliance. Ensure clinical trial operations meet KPHP and KFRI standards and are consistent with the standards of Nursing Practice Act, Guidelines for Good Clinical Practices, federal, state and local regulations. Work closely with Research Compliance to align procedures and practices for optimal clinical outcomes and compliance.
- Manages clinical research operations which may involve multiple locations. Collaborate with investigator team, Health Plan Managers, and CHR Managers, to develop and plan departmental clinical research. Assess the impact of new clinical research on finances, current research portfolio, staffing, and other KPNW departments.
- Manages hiring and the annual performance evaluation process for clinical research staff. In conjunction with HR and management, coaches and counsels staff who are non-compliant with applicable KP policies, procedures and standards.
Basic Qualifications:
Experience
- Minimum three (3) years of a clinical health care management experience.
- Minimum five (5) years of human subjects research and outpatient nursing/provider experience.
Education
- Bachelors degree in nursing OR associate degree/diploma in nursing with two (2) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- Registered Nurse License (Oregon) required at hire.
Additional Requirements:
- Thorough knowledge in the science of clinical research management and health care administration.
- Thorough knowledge of federal, state and international regulations governing the conduct of clinical trials.
- Broad knowledge base of diverse medical health care issues.
- Effective communicator.
- Demonstrated leadership and training skills.
- Program development skills and collaborative practice experience.
- Adept at conflict resolution.
- Demonstrated customer-focused service skills.
- Working knowledge of clinical pharmacology and research methodology; working knowledge of health education.
- Thorough knowledge of human resource practices and systems; facility planning and accounting/financial principles and practices.
Preferred Qualifications:
- CCRP, CCRC or CCRA.
- Masters degree in nursing or related field.
- Preferred Qualification: Nurse Practitioner (NP) or DNP.
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