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Clinical Research Nurse Manager Oakland, CA



Description

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.

Essential 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.
- Develops 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 (The Joint Commission) regulatory requirements which govern the testing of investigational drugs and vaccines.
- 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.


Qualifications:

Basic Qualifications:
Experience
- Minimum five (5) years of experience 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 outpatient care experience.
Education
- Bachelor's degree in nursing or related health field required.
- Graduate of an accredited school of nursing.
Licenses, Certifications, Registrations
- Current California RN license required.
- Current BCLS.

Additional Requirements:
- Excellent project management, written and oral communications, and statistical analysis skills.
- Must be able to work in a Labor/Management Partnership environment.

Preferred Qualifications:

Directs, coordinates, leads, and facilitates multiple research trials and observational studies. Provides 24/7 call availability for all equipment and operational related emergencies at the DOR research clinic. Will immediately acknowledge all freezer alarm activations and resolve according to established procedures within the OMC Security and Engineering Departments. Responsible for developing and maintaining relevant manuals of procedures and standard opera ting procedure resources for research facilities and protocols. Experience performing research protocol vital signs, anthropometry, and 12-lead electrocardiogram. Performs as a point person for decision-making and problem solving day to day operation of projects and clinic operations.


Primary Location: California,Oakland,Oakland Mosswood Medical Offices 3505 Broadway

Scheduled Hours (1-40): 40

Shift: Day

Working Days: Mon - Fri

Schedule: Full-time

Job Type: Standard

Employee Status: Regular

Employee Group: Salaried, Non-Union, Exempt

Job Level: Manager with Direct Reports

Job: Research and Development

Public Department Name: Clinical Research Support Staff Admin


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.

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