Clinical Research Coord III

Position Summary The Clinical Research Coordinator II will develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research. This position will support the growth of the Winnie Palmer Hospital OBGYN Residency and Fellowship Programs.

Facility: Winnie Palmer Hospital Location: Orlando, Florida Type: Full Time Shift:

M-Fri 8:00am-4:00pm Responsibilities Essential Functions • 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 required. Preference: Writing/Protocol Writing, Statistics

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 required. Preference: Writing/Protocol Writing, Statistics

Essential Functions • 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