<p>Position Summary Department: Research and Clinical Trial Shift: Day/Full Time Location: Orlando Fl - Corp Title: Clinical Research Coord level 3 Summary: Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research. "Orlando Health Is Your Best Place to Work" is not just something we say, it's our promise to you." Orlando Health proudly embraces and honors the individuality of our team members. By sharing different ideas and perspectives and working together as a team, we are better able to relate to, care for and authentically serve our patients and families who make up the collective populations in our community. So, no matter who you are, what you believe or how you express yourself, you are welcome here. ORLANDO HEALTH - BENEFITS & PERKS: Competitive Pay Evening, nights, and weekend shift differentials offered for qualifying positions. All Inclusive Benefits (start day one) Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees. Forbes Recognizes Orlando Health as a Best-In-State Employer Forbes has named Orlando Health as one of America's Best-In-State Employers for 2021. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, VP (HR). "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued. Employee-centric Orlando Health has been selected as one of the "Best Places to Work in Healthcare" by Modern Healthcare. 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. 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). Experience Two (s) years of clinical or research experience required. A Master's degree in a health-related field may substitute for up to two (2) years clinical research experience.</p> <p>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. 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). Experience Two (s) years of clinical or research experience required. A Master's degree in a health-related field may substitute for up to two (2) years clinical research experience.</p> <p>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</p>