Clinical Research Coord II Orlando Health - 3.8 Orlando, FL Job Details Full-time 17 hours ago Qualifications Collaborate with healthcare professionals Nursing Respiratory Therapy Adverse event reporting Healthcare Administration BLS Certification Associate's degree in respiratory therapy Mid-level Associate's degree in healthcare administration Research project coordination Adverse drug reaction monitoring Patient care Associate's degree in health information management Patient family and caregiver education Implementing research protocols Bachelor's degree in healthcare administration Bachelor's degree in nursing Communication with regulatory authorities for clinical trials Clinical research inspection readiness Patient progress monitoring Bachelor's degree in health information management Health Information Management IRB compliance 1 year Research participation Bachelor's degree in respiratory therapy Associate's degree Associate Degree in Nursing Healthcare Provider Certification Ethical review application preparation

Full Job Description 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.