Kaiser Permanente CLINICAL RESEARCH SUPPORT SERVICES SENIOR MANAGER-CHR - Research Management; Clinical Trials Administratior (Portland) in Portland, Oregon

The Manager for Clinical Research Support Services (CRSS) has administrative oversight over three different research areas within KPNW - delivery system clinical trials, the research clinic, and the research lab. The Manager is responsible for management of clinical trials within KPNW ensuring clinical trials are supported by qualified research staff and conducted in compliance with regulations, sponsor requirements and policies and procedures and are financially sound. This includes clinical trials performed by Permanente physicians in their clinical practices in the KPNW region, and CHR Investigators conducting clinical trials either in the CHR Research Clinic or using CRSS staff in the community. This position is responsible for management of the NW Research Laboratory (NWRL) operations to support genomics and genetics research.

Essential Responsibilities:

In collaboration with CHR leaders and appropriate regional leaders, coordinate the development and implementation of the strategic vision that represents the needs of KPNW physicians and CHR investigators conducting clinical research trials. Develop the infrastructure to provide clinical trial support for KPNW physicians and CHR investigators conducting clinical research trials. Ensure the development and adherence to department policies and procedures providing an innovative infrastructure that meets CHR, KP, and sponsor needs and requirements. Provide oversight for all clinical trials that involve Federal Drug Administration (FDA) regulated medications, unapproved diagnostic tests or unapproved medical devices within KPNW. Collaborate with other KPNW leaders in the development of HP or Permanente compliance policies and procedures related to the conduct of clinical trials.

Collaborate with investigator teams, Health Plan Managers and Directors to develop and plan their departmental strategic research vision. Analyze the impact of new programs/sites on other KPNW departments and CRSS resources.

Manage the NW Research Lab (NWRL) activities including continued program development, policies, SOPs, staffing, carrying out strategic initiatives, and responsibilities for operational budget.

Oversight of revenue, expenses and contracting. Establish and maintain programs based on fiscal viability and self-supported funding. Direct, manage and plan the combined revenue and expense department budget. Maintain updated operating budget. Oversee the preparation and approve clinical research project budgets. Facilitate the negotiation process of Clinical Trial Agreements.

Responsible for hiring, firing, performance appraisals, recruitment, retention and staff development plans for CRSS department and CHR projects requiring clinical licensure (RN, NP) or expertise. Ensure research staff understands the clinical requirements for project implementation. Provide CRSS expertise in the conduct of clinical trials assuring compliance with rules, regulations, and pertinent policies.

Serve as an active member of the CHR Central Operations Group (COG), CHR Research Compliance Committee (CHR RCC), ABC, and Research Response Team (RRT). Participate on KPNW clinical and operational committees to provide research representation. Act as a liaison with KPNW delivery system departments to develop and implement strategies that facilitate research and minimize department burden. Provide expertise related to the conduct of clinical trials and the development of CHR policies and procedures to CHR Leadership and Investigators.

Oversight of the utilization of the Clinical Trials software systems. Work with technology groups, investigators and stakeholders and other key stakeholders to evaluate new technology systems that promote cost effectiveness. Collaborate on the design, development, implementation and management of the department's technology and information system needs.

Basic Qualifications:

Experience

Minimum five (5) years of a high-level clinical health care management experience.

Minimum five (5) years of human subjects research and outpatient nursing/provider experience.

Education

Master's degree in nursing, NP OR six (6) years of experience in a directly related field.

High School Diploma or General Education Development (GED) required.

License, Certification, Registration

Current Oregon OR Washington RN, PA, MD, or NP license in state where assigned required upon hire/transfer.

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.

Doctoral degree in clinical/medical field.

COMPANY: KAISER

TITLE: CLINICAL RESEARCH SUPPORT SERVICES SENIOR MANAGER-CHR - Research Management; Clinical Trials Administratior (Portland)

LOCATION: Portland, Oregon

REQNUMBER: 761973

External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.