Highmark Health
Location
Pittsburgh, Pennsylvania
The role involves planning and managing clinical trials while ensuring compliance with regulatory bodies and human subject research standards. Key duties include identifying eligible patients, providing education to staff and participants, and maintaining clinical data and regulatory binders.
Candidates must have a minimum of an Associate's degree, RN, or equivalent research experience with 1-3 years of related experience. A Bachelor's degree and professional certifications such as CCRC or CCRP are preferred.
Company: Allegheny Health Network
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 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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