Clinical Research Coordinator Lead

Description

GENERAL OVERVIEW :

Plans, coordinates, and manages the activities associated with the initiation and completion of clinical trials, sponsored by internal, industry, foundation, and / or Federal funding sources.

Maintains compliance with all regulatory bodies associated with human subject research.

ESSENTIAL RESPONSIBILITIES :

• Serves as liaison between clinical research team and hospital / research institute senior leaders. Provides strategic direction on clinical research portfolio and clinical research pipeline, issue resolution and quality improvement initiatives. (30%)
• Interfaces between clinical staff, the Office of Sponsored Research, Research Administration, PIs, clinical research staff, and external entities to create and adhere to programmatic budgets and strategic plans. (20%)
• Interfaces with clinical staff to identify patients eligible for clinical trials across one or multiple sites of service.

Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (20%)

Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure they are informed prior to obtaining written consent.

Completes required follow-up and active patient monitoring per study protocol at one or multiple sites of service. (20%)

• Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies. (5%)
• Performs other duties as assigned or required. (5%)

QUALIFICATIONS : Minimum

Minimum

• Bachelor’s Degree in biology, nursing, healthcare or closely related field
• 5-7 years’ related experience.
• Current research-related certification from accredited program such as The Association of Clinical Research Professional (ACRP), e.

g. Certified Clinical Research Coordinator (CCRC), ACRP Certified Professional (ACRP-CP) or The Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professionals (CCRP) or within 6 months of hire.

Driver's license may be required depending on facility requirements.

Preferred

Master's degree in related field.

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Equal Opportunity Employer Minorities / Women / Protected Veterans / Disabled / Sexual Orientation / Gender Identity ()

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