Clinical Research Data Coordinator II - Digestive Health Institute

Position Summary Clinical Researcy Data Coordinator II - Digestive Health Institute - Downtown ORLANDO HEALTH DIGESTIVE HEALTH INSTITUTE Orlando Health Digestive Health Institute is an international destination for care, offering comprehensive and coordinated services to evaluate, diagnose and treat a wide range of conditions affecting the digestive tract and gastrointestinal organs. The institute has distinguished itself worldwide in offering many diagnostic and treatment options, including artificial intelligence (AI) capabilities that improve diagnosis, treatment and outcomes. The institute brings internationally recognized digestive disease care to a new state-of-the-art facility in downtown Orlando as well as several satellite sites conveniently located within the Orlando Health system. Orlando Health Digestive Health Institute is part of the Orlando Health system of care, which includes award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities that span Florida’s east to west coasts and beyond. Collectively, our 27,000+ team members honor our over 100-year legacy by providing professional and compassionate care to the patients, families and communities we serve. Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever possible so that you can be present for your passions. “Orlando Health Is Your Best Place to Work” is not just something we say, it’s our promise to you. Position Summary The Clinical Data Coordinator is responsible for the collection, abstraction, review, documentation and monitoring of data related to clinical research projects. Responsibilities Essential Functions • Responsible for working collaboratively with clinical research coordinators, regulatory coordinators, physicians, nurse clinicians, pharmacy, and laboratory personnel to ensure tests/procedures/specimen collections, etc. are obtained per protocol. • Assist in the identification, collection and reporting of adverse events and serious adverse events in accordance with ICH, CFR, GCP and protocol specific guidelines. • Prepare and provide patient status reports to leadership as requested. • Serve as point of contact for respective sponsor monitoring visits. • Ensure accurate and timely retrieval and submission of protocol driven data points from internal and external stakeholdersincluding but not limited to data forms, study related materials (slides, pathology, operative reports, and radiology reports) to the relevant cooperative or industry-based groups for patients placed on clinical trials. • Participate in audits conducted by sponsors and other regulating authorities. • Identify, research, resolve and report data discrepancies • Prepares new study patient charts • Maintains a registry of study patients at the relevant time points • Assists in the internal data quality and control process. • Conduct survival follow up visits as applicable. • Demonstrate the ability to work with Pharmaceutical Sponsored, National Clinical Trials Network, and Investigator-Initiated trials. • Ability to cover clinical data coordination and query resolution outside of primary study assignments. • Act as single point of contact (internal expert) for specific processing task(s) on a project • Responsible for the completeness, timely delivery, and quality of clinical data • Manage project timelines, quality issues and justify out-of-scope • Successfully manage simultaneous trials and meet deadlines • Serves as a resource for Clinical Data Coordinators and other research staff members. • Maintainsreasonably 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 • Attends appropriate departmental, corporate and continuing education meetings as required. • Assumes the responsibility for professional growth and development. • Transmits data to sponsoring and regulatory agencies. • Maintain flexible hours to meet clinical trial specific requirements, data locks and audits. • May be required to draw blood from existing peripheral IVs after appropriate Orlando Health training and competency check-off. • May schedule appointments and/or tests, after consulting with investigators for protocol compliance. • Able to discuss protocol participation with patients and keep them informed of procedures and changes to the study. • Assists in the reconsenting process by securing the necessary signatures. Qualifications Education/Training Associates degree with four (4) years’ experience in research or healthcare OR; Bachelor’s degree with two (2) years’ experience in research or healthcare. If no degree, experience may be substituted at a 2 for one ratio. Licensure/Certification • Must be eligible for Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator (ACRP). • Orlando Health phlebotomy course within 30 days of hire is required within certain areas. Essential Functions • Responsible for working collaboratively with clinical research coordinators, regulatory coordinators, physicians, nurse clinicians, pharmacy, and laboratory personnel to ensure tests/procedures/specimen collections, etc. are obtained per protocol. • Assist in the identification, collection and reporting of adverse events and serious adverse events in accordance with ICH, CFR, GCP and protocol specific guidelines. • Prepare and provide patient status reports to leadership as requested. • Serve as point of contact for respective sponsor monitoring visits. • Ensure accurate and timely retrieval and submission of protocol driven data points from internal and external stakeholdersincluding but not limited to data forms, study related materials (slides, pathology, operative reports, and radiology reports) to the relevant cooperative or industry-based groups for patients placed on clinical trials. • Participate in audits conducted by sponsors and other regulating authorities. • Identify, research, resolve and report data discrepancies • Prepares new study patient charts • Maintains a registry of study patients at the relevant time points • Assists in the internal data quality and control process. • Conduct survival follow up visits as applicable. • Demonstrate the ability to work with Pharmaceutical Sponsored, National Clinical Trials Network, and Investigator-Initiated trials. • Ability to cover clinical data coordination and query resolution outside of primary study assignments. • Act as single point of contact (internal expert) for specific processing task(s) on a project • Responsible for the completeness, timely delivery, and quality of clinical data • Manage project timelines, quality issues and justify out-of-scope • Successfully manage simultaneous trials and meet deadlines • Serves as a resource for Clinical Data Coordinators and other research staff members. • Maintainsreasonably 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 • Attends appropriate departmental, corporate and continuing education meetings as required. • Assumes the responsibility for professional growth and development. • Transmits data to sponsoring and regulatory agencies. • Maintain flexible hours to meet clinical trial specific requirements, data locks and audits. • May be required to draw blood from existing peripheral IVs after appropriate Orlando Health training and competency check-off. • May schedule appointments and/or tests, after consulting with investigators for protocol compliance. • Able to discuss protocol participation with patients and keep them informed of procedures and changes to the study. • Assists in the reconsenting process by securing the necessary signatures. Education/Training Associates degree with four (4) years’ experience in research or healthcare OR; Bachelor’s degree with two (2) years’ experience in research or healthcare. If no degree, experience may be substituted at a 2 for one ratio. Licensure/Certification • Must be eligible for Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator (ACRP). • Orlando Health phlebotomy course within 30 days of hire is required within certain areas.