Description
GENERAL OVERVIEW :
This job 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 :
- Interfaces with clinical staff to identify patients eligible for clinical trials. Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (30%)
- Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent.
Completes required follow-up and active patient monitoring per study protocol. (30%)
- Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (15%)
- 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. (15%)
- Performs other duties as assigned or required. (10%)
QUALIFICATIONS : Minimum
Minimum
- Associate's degree, RN, or equivalent research experience.
- 1-3 years’ related experience.
Preferred
- Bachelor’s Degree.
- 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).
Driver's license may be required depending on facility requirements.
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Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, age, religion, sex, national origin, sexual orientation / gender identity, protected veteran status or disability.
EEO is The Law
Equal Opportunity Employer Minorities / Women / Protected Veterans / Disabled / Sexual Orientation / Gender Identity ()
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