Clinical Research Coord Iii

Position Summary
Department: Corp Office of Research Operat
Status: Full-time
Shift: Day
Title: Clinical Research Coord III
Position Summary:
Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research
Responsibilities
• Assists in training, developing, and supervising the work of the Clinical Research Coordinators I & II.
• Performs a variety of duties involved in standardization of operating procedures across all trials.
• Coordinate 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.
• Coordinates 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.
• Assist 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.
Other Related Functions
• 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.
• Pre-screen patients who are potential candidates for clinical trials at Orlando Health
Qualifications
Education/Training:
• Bachelor's degree in a health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness
or Health Information Management, or other).
• Associate degree in a health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness
or Health Information Management) and two (2) years of directly related work experience may substitute for the Bachelor's
degree (in additional to the requirements listed in the Experience section.
• Graduate of an accredited allied health program and three (3) years 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 six (6) years Clinical Research
experience require
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.
• Maintains current CCRC/CCRP Certification (Certified Research Coordinator) by the Association of Research Professionals or
SOCRA (Society of Clinical Research Associates).