Clinical Research Coord - Research - Full Time - Corp

Position Summary A Brief Overview Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research. Responsibilities What you will do 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). 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. Support the team of data managers by answering complex questions and entering information into the EDC if necessary. Qualifications 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. Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. Section 1557 Non-Discrimination The Office for Civil Rights (OCR) enforces Section 1557 of the Affordable Care Act (Section 1557), which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities. 42 U.S.C. 18116. Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

What you will do 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). 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. Support the team of data managers by answering complex questions and entering information into the EDC if necessary.

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. Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. Section 1557 Non-Discrimination The Office for Civil Rights (OCR) enforces Section 1557 of the Affordable Care Act (Section 1557), which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities. 42 U.S.C. 18116. Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.