Clinical Research Coord II

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.

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.

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.