Clinical Research Regulatory Coordinator II - Digestive Health Institute

Orlando Health•Orlando, FL

About The Position

Clinical Research Regulatory Coordinator II - Digestive Health Research - 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 Research Regulatory Coordinator II prepares and submits multiple levels of research documentation to federal, state, and local regulatory authorities. This documentation includes but is not limited to IRB submissions (local and central IRBs), educational materials, safety and deviation reports, and study forms. May prepare and maintain additional submissions to regulating authorities, such as the Federal Drug Administration and Institutional Biosafety Committees and Radiation Safety Committees. Leads the mplementation of study specific regulatory processes of a moderate to complex nature.

Requirements

Associates degree with four (4) years’ experience in research OR;
Bachelor’s degree with two (2) years’ experience in research.
If no degree, experience may be substituted at a 2 for one ratio.
Must be eligible for Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator (ACRP).

Responsibilities

Prepares and submits both local and central Institutional Review Board (IRB) documents for new trials, continuing reviews, amendments, safety events, and protocol deviations independently.
Maintains both paper and electronic regulatory binders for all clinical trials.
Prepares study documentation for long-term storage.
Prepares for monitoring visits and audits of regulatory records
Provide guidance to less experienced staff
Familiar with regulatory requirements for industry, national and investigator-initiated trials.
Liaison between the Principal Investigator, FDA, pharmaceutical sponsors, consortium partners, other funding entities , and the IRB and ancillary review committees.
Responds and resolves queries from the regulatory governing bodies.
Collaborates with other Hospital departments acting as a research regulatory resource.
Assists with quality assurance activities for the department.
May coordinate and assist with external audits and monitor visits.
Respects diversity by building respectful relationships with all team members, investigators, sponsors, and regulatory authorities
Assesses clinical trial needs and develops/revises priorities based on needs and responses. Evaluates trial progress toward and reports as applicable.
Demonstrates competency in regulatory affairs as defined by department-specific requisite skills.
Prioritizes clinical trial needs based on trial status, participant, and departmental needs
Practices effective problem identification and resolution.
Demonstrates awareness of legal issues
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.
Attends team, staff and departmental meetings as required.
Demonstrates expertise of computer software specific to department.

Benefits

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.

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