SUPERVISOR CLINICAL RESEARCH - HMTS - HMG ADMINISTRATION

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Date: Jun 9, 2017

Location: Huntington Beach, CA, US

Company: Hoag Memorial Hospital Presbyterian

Job Description:

Full-Time, 1st Shift 

 

The Supervisor of Clinical Research (SCR) assists in overseeing clinical research operational activities at all HMG-HMTS facilities. The SCR assures all clinical research conducted at HMG-HMTS reflects best practices and industry standards. Assists in ensuring that proposed projects meet the mission and vision of HMG-HMTS and all Clinical Research stakeholders. The SCR supervises clinical research coordinators, both nurses and non-nurses, financial and regulatory specialists. Assumes Research Coordinator activities when other coordinator resources are at capacity, or on leave. Serves as the first point of contact for new physicians and sponsors regarding study start-up processes and training. Responsible for oversight of document recording, tracking and updates of new clinical research study start-up process (i.e. contracts, budgets, informed consent, etc.). Assists with development and renewal of clinical research policies. Works with Director of clinical research on issues requiring problem-solving. Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research as well as responsibilities of Research Coordinator RN position.

 

Essential Functions

• Responsible for assisting with recruitment and hiring, and directly managing all clinical research staff including coaching, counseling, oversight of daily activities, performance reviews as well as assisting with termination decisions

• Responsible for pro-active policy and procedure development and revisions to meet industry standards

• Keeps current with Clinical Research Coordinator and Clinical Nurse Research Coordinator responsibilities and current research studies to enable ability to cover for Clinical Research Coordinators as needed.

• Works with Director of Clinical Research on team meeting agendas and issues and supports the Director regarding direction and decisions.

• Provide physicians with support, information and continuing training on conduct of clinical research at Hoag

• Promotes a culture of compliance by modeling ethical behavior and teaching Good Clinical Practice and scientific integrity that pervade all areas of research

• Communicates with Marketing to ensure Hoag Clinical Research Website is current and works with Director of Clinical Research to create communication opportunities for research studies.

• Perform other duties as assigned

 

Education, Training and Experience

Required:

• Registered Nurse (RN)

• Minimum 1 year experience in research.

• Minimum three years professional experience in health care.

• Project leadership or supervisory experience

• Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines.

Preferred: N/A

 

Skills or Other Qualifications

Required: Detail oriented. Knowledge of cross-functional understanding of clinical trial methodology. Personnel and supervisory experience required. Ability to work independently and in a team environment. Clear and concise verbal and written communication skills. Project management and organizational skills. Computer knowledge in Microsoft windows applications including Word, Outlook and Excel and familiarity with electronic data capture systems preferred. Monitors research team project activity to ensure compliance with appropriate regulatory/agency requirements/regulations.

Preferred: N/A

 

License and Certifications

Required: • Current licensure in good standing as a Registered Nurse in the State of California • Bachelor of Science in Nursing (BSN)• Holds current Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or complete within two years of hire.

Preferred: N/A

 

*LI-JS1


Nearest Major Market: Orange County
Nearest Secondary Market: Los Angeles

Job Segment: Manager, Law, Compliance, Project Manager, Management, Research, Legal, Technology

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