Clinical Research Support Services Director
3 weeks ago
The Clinical Research Support Services Manager is responsible for overseeing and coordinating clinical research trials and the multi-disciplinary research team in testing and evaluation of interventions, investigational drugs, biologics, and devices. This role works directly with sponsors and investigators, ensuring compliance with organizational SOPs and government regulations for the conduct of research with human subjects.
Key Responsibilities:
- Collaborate with principal investigators, study sponsors, and regional leads to establish, implement, and conduct clinical research trials within the departmental area, evaluating feasibility based on capacity and resources.
- Manage budget preparation, revenue, and expenses for designated portfolios, monitoring trial budgets for resource utilization and effective management.
- Ensure clinical trial operations meet KPHP and KFRI standards, aligning procedures and practices for optimal clinical outcomes and compliance.
- Manage clinical research operations across multiple locations, collaborating with investigator teams, Health Plan Managers, and CHR Managers to develop and plan departmental clinical research.
- Oversee hiring and annual performance evaluations for clinical research staff, coaching and counseling staff on compliance with applicable KP policies and standards.
Qualifications:
- Minimum three years of clinical health care management experience.
- Minimum five years of human subjects research and outpatient nursing/provider experience.
- Bachelor's degree in nursing or associate degree/diploma in nursing with two years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
- Registered Nurse License (Oregon) required at hire.
- Thorough knowledge 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.
- CCRP, CCRC, or CCRA.
- Masters degree in nursing or related field.
- Preferred Qualification: Nurse Practitioner (NP) or DNP.
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