Clinical Research Coord - Day - Full Time - Arnold Palmer

About the Role

Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research.

Responsibilities

• 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).
• Assess patients for protocol eligibility and communicate findings to investigator/physician.
• Coordinate the implementation of protocol procedures.
• Operate specialized equipment as needed in assigned area, if applicable.
• Assess and monitor patient responses and adverse reactions; report same to accountable sources.
• Provide appropriate patient and family education.
• Complete a variety of reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
• Collaborate 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.
• Provide educational in-services as needed.
• Promote interdepartmental cooperation and coordination for each protocol.
• Maintain reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state, and local standards.
• Maintain compliance with all Orlando Health policies and procedures.
• Assist in the development of treatment orders for active studies, to be reviewed by the treating physician.
• Assist the research team in preparing for site audits.
• Attend appropriate departmental and/or corporate meetings.
• Attend study group and investigator meetings as required.
• Demonstrate ability in using computer software specific to department.
• Support the team of data managers by answering complex questions and entering information into the EDC if necessary.

Qualifications

Must meet one of the following:

• Bachelor’s degree in health-related field (i.e., Healthcare Administrative, 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 one-year clinical research experience required.

• One (1) year of healthcare experience required.
• 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.