Clinical Research Coord II

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. Responsibilities: 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).

Position Summary:

Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research

Responsibilities:

• 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.
• 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.

 

Qualifications:

• Must meet one of the following:
• Bachelor’s degree in health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management); or
• 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
• 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 two years clinical research experience required.
• Minimum of (1) year clinical research experience.
• All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the medical director.
• Must be eligible for Certified Research Coordinator CCRC/CCRP by the Association of Research Professionals or SOCRA (Society of Clinical Research Associates within one year of hire.
• BLS/Healthcare Provider certification required.