Description
Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve.
Summary: Provides education and communication on clinical research activities and ensures compliance for all studies by following protocols and procedures.
Responsibilities:
- Review research protocols to determine availability of resources, subjects and equipment needs.
- Educates patients and families about clinical trials, potential benefits and goals of clinical research.
- Communicates to physicians and other staff concerning protocols that are open to enrollment.
- Obtain written informed consent with appropriate HIPAA authorization from each patient prior to study enrollment.
- Conducts study as outlined by protocol.
- Follows established guidelines in the collection of data.
- Ensures regulatory compliance for each study by following IRB policies and procedures, study requirements, federal regulations, etc.
- Participate in sponsor audits and/or regulatory inspections of records and documents (e.g. FDA, CLGB/NSABP).
Other Information:
Education Requirements:
* Bachelor's degree (BSN) from an accredited school of Nursing. Master's preferred.
Licensure/Certification Requirements:
* RN NC LIC; BCLS
* Certification in Specialty and Clinical Research preferred.
Professional Experience Requirements:
* Two years of relevant experience required.
Knowledge/Skills/and Abilities Requirements:
* LANGUAGE SKILLS: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
* MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole
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