Clinical Research Reg Coord

Position Summary:

Orlando Health - Quality Assurance & Research

Title: Clinical Research Reg Coord II

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

implementation of study specific regulatory processes of a moderate to complex nature.

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.”

So, no matter who you are, what you believe or how you express yourself, you are welcome here.

ORLANDO HEALTH - BENEFITS & PERKS:

• Evening, nights, and weekend shift differentials offered for qualifying positions.

• 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 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.

• Orlando Health has been selected as one of the “Best Places to Work in Healthcare” by Modern Healthcare.

Responsibilities:

• Prepares and submits both local and central Institutional Review Board (IRB) documents for new trials, continuing reviews,

• 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

• 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

• 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

• 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.

Qualifications:

Education/Training

If no degree, experience may be substituted at a 2 for one ratio.

Licensure/Certification

Research Coordinator (ACRP).

• regulatory and IRB submission experience.
• Central IRBs
• Investigator initiated studies