Clinical Research Coord I

Essential Functions

• Participate in the coordination of multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).
• Assesses patients for protocol eligibility and communicates findings to investigator/physician.
• Coincides the implementation of protocol procedures.
• Operates specialized equipment as needed in assigned area, if applicable.
• Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
• Provides appropriate patient and family education.
• Completes a variety of reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
• Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
• Aid in the preparation and submission of amendments to clinical trials protocols to the IRB.
• Provides educational in-services as needed.
• Promotes interdepartmental cooperation and coordination for each protocol.
• Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state, and local standards.
• Maintains compliance with all Orlando Health policies and procedures.
• Assists in the development of treatment orders for active studies, to be reviewed by the treating physician.
• Assists the research team in preparing for site audits.
• Attends appropriate departmental and/or corporate meetings.
• Attends study group and investigator meetings as required.
• Demonstrates ability in using computer software specific to department.
• Supports the team of data managers by answering complex questions and entering information into the EDC if necessary.

Other Related Functions

• Supports the team of data managers by answering complex questions and entering information into the EDC if necessary.

Education/Training

• Must meet one of the following:
• A Bachelor’s degree in health-related field (i.e., Healthcare Administrative, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management); or
• An Associate degree in related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management) and one (1) year of clinical research or healthcare experience (in addition to the requirements listed in the Experience section); or
• A Graduate of an accredited allied health program and one (1) year of clinical research or healthcare experience (in addition To The Requirements Listed In The Experience Section).
• If no degree, experience may be substituted at a two for one ratio and a minimum of one-year clinical research experience required.
• Licensure/Certification: All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the medical director. BLS/Healthcare Provider certification required.

Experience

• One (1) year of healthcare experience required.