Regulatory Coordinator
2 weeks ago
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
implementation of study specific regulatory processes of a moderate to complex nature.
* 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
Education/Training
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.
Licensure/Certification
Must be eligible for Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical
Research Coordinator (ACRP).
-
PIPS Coordinator Sr
7 days ago
Orlando, Florida, United States Nemours Full timeThis position is responsible for the coordination of performance improvement, continuous regulatory readiness and patient safety activities for Nemours Children's Health, Florida which includes the Hospital, satellite locations, affiliate operations and other locations as assigned. Responsibilities include oversight and direct participation in the...
-
68048719 - regulatory specialist i
8 hours ago
Orlando, Florida, United States State Of Florida Full timeRequisition No:Agency: Agency for Health Care AdministrationWorking Title: # - REGULATORY SPECIALIST IPay Plan: Career ServicePosition Number: # Salary: $1,260.00 Biweekly Posting Closing Date: 05/02/2024 Total Compensation Estimator ToolThe incumbent in this position performs independent work handling the daily administrative and operational functions of...
-
IRB Coordinator II
2 weeks ago
Orlando, United States Orlando Health Full timePosition Summary: The IRB Coordinator II is responsible for the review and approval process of proposed documentation for research activities involving human subjects to protect their safety, rights, and welfare. This documentation includes but is not limited to regulatory submissions from all research departments, educational materials, safety and deviation...
-
IRB Coordinator II
3 weeks ago
Orlando, Florida, United States Orlando Health Full timePosition Summary: The IRB Coordinator II is responsible for the review and approval process of proposed documentation for research activities involving human subjects to protect their safety, rights, and welfare. This documentation includes but is not limited to regulatory submissions from all research departments, educational materials, safety and deviation...
-
Clinical Research Coordinator
2 weeks ago
Orlando, United States Nemours Foundation Full timeThe Nemours Clinical Research Coordinator implements, coordinates and completes clinical research studies and/or clinical trials by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and...
-
Accounting Coordinator
4 weeks ago
Orlando, Florida, United States Darden Restaurants, Inc. Full timeAccounting Coordinator - iBuy AP 1000 Darden Center Dr, Orlando FL 32837 Job Description JOB OVERVIEW: The Accounts Payable Coordinator, iBuy Processing, supports the iBuy RSC Invoice Processing team by managing procedural and administrative tasks which ensure timely processing of invoices and compliance with generally accepted standard accounting...
-
Lab Coordinator
2 weeks ago
Orlando, United States Orlando Health Full timePosition Summary Olando Health Arnold Palmer Hospital for Children Providing compassionate care to the children, teenagers and young adults of Central Florida for more than 30 years, Orlando Health Arnold Palmer Hospital for Children is located on the downtown Orlando campus and includes 156 licensed beds for specialized care for children as well as the...
-
Lab Coordinator
1 month ago
Orlando, United States Orlando Health Full timePosition Summary: **Olando Health Arnold Palmer Hospital for Children** Providing compassionate care to the children, teenagers and young adults of Central Florida for more than 30 years, Orlando Health Arnold Palmer Hospital for Children is located on the downtown Orlando campus and includes 156 licensed beds for specialized care for children as well as...
-
Clinical Research Coordinator CRC
3 hours ago
Orlando, United States Omega Research Full timeJob DescriptionJob DescriptionHere we grow again! Our busy clinical research sites in Debary and Orlando are looking for new study coordinators to join our team! The ideal candidate will have experience working with phase 1, 2, and/or 3 clinical trials in various indications including ulcerative colitis, crohn's disease, kidney disease, liver disease,...
-
Cardiology QA Coordinator, CVOR, Full-time/Days
2 weeks ago
Orlando, United States Orlando Health Full timePosition Summary Organizes, develops, implements, maintains and monitors all aspects of Performance Improvement standards that meet federal, state and local requirements for Cardiac Diagnostics and Interventional Services in our local cardiology department. CVOR, Full-time/Days Responsibilities • Develops, implements, measures and communicates PI...
-
Clinical Research Coordinator
2 weeks ago
Orlando, United States NEO HR Consulting Group Full timeResponsibilities:Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies;Maintains required records of study activity, including case report forms, drug dispensation records, and regulatory forms;Tracks enrollment status of subjects and documents dropout...
-
Resident Service Coordinator- Acclaim at Conroy
3 weeks ago
Orlando, United States Avanath Full timeJob DescriptionJob DescriptionOverviewAvanath is proud to be named one of the top property management companies to provide affordable housing for the work force.Cultivating the American Dream is the purpose that binds the Avanath team. At Avanath, every day is an opportunity to make a difference in someone's life. Whether it is helping residents call one...
-
Research Assistant 226622
3 weeks ago
Orlando, United States Medix™ Full timeWe are looking for a Research Assistant to join our growing team- this is a full time onsite position. We offer a competitive salary, bonus potential and have a great benefits package. If you are looking to join a site that is part of a national organization with lots of room to grow, this is the role for you. Position SummaryThe research assistant is...
-
Research Assistant 226622
2 weeks ago
Orlando, United States Medix™ Full timeWe are looking for a Research Assistant to join our growing team- this is a full time onsite position. We offer a competitive salary, bonus potential and have a great benefits package. If you are looking to join a site that is part of a national organization with lots of room to grow, this is the role for you. Position SummaryThe research assistant is...
-
Orlando, United States Orlando Health Full timePosition Summary The Lead Pharmacy Tech functions as a staff-level leader in their department and will take on both the duties of a Pharmacy Tech and certain department leadership tasks as well. *Position is located at 392 Rinehart Rd | Lake Mary, Fl 32746* Responsibilities Essential Functions • Demonstrates an understanding of safety, emergency and risk...
-
Medical Biller
1 day ago
Orlando, United States Select Source International Pvt Ltd Full timeJob title :Medical Billing Specialist Duration :6 months Location :Orlando,FL 32810 Pay :$25/hr Job Description This position is responsible for, but not limited to, the following: . Assures that all phases of processing client information are in compliance with HIPAA, PHI regulatory and related policies and practices; reports any Compliance issues to...
-
Risk Operations Manager
6 days ago
Orlando, United States Orlando Health Full timePosition Summary: Orlando Health is seeking a Risk Operations Manager for their corporate headquarters. As the Risk Prevention Manager, you will be responsible for the facility or assigned areas risk management activities. The ideal candidate will possess a clinical background with substantial experience in clinical risk management. This role requires a...
-
Inhouse Marketing Coordinator
4 weeks ago
Orlando, United States Travel + Leisure Full timeWe Put the World on VacationAt Travel + Leisure Co., our mission is simple: to put the world on vacation. Our Vacation Ownership business line includes Club Wyndham, WorldMark by Wyndham, Margaritaville Vacation Club, Accor Vacation Club and the brand new Sports Illustrated Resorts. Our more than 19,000 associates put the world on vacation at more than 270...
-
In House Marketing Coordinator
6 days ago
Orlando, United States Wyndham Destinations Full timeWe Put the World on VacationAt Travel + Leisure Co., our mission is simple: to put the world on vacation. Our Vacation Ownership business line includes Club Wyndham, WorldMark by Wyndham, Margaritaville Vacation Club, Accor Vacation Club and the brand new Sports Illustrated Resorts. Our more than 19,000 associates put the world on vacation at more than 270...
-
Cardiology QA Coordinator, Full-time, Days
4 weeks ago
Orlando, Florida, United States Orlando Health Full timePosition Summary: Organizes, develops, implements, maintains and monitors all aspects of Performance Improvement standards that meet federal, state and local requirements for Cardiac Diagnostics and Interventional Services in our local cardiology department. Qualifications: Education/Training • Graduate of an accredited Registered Nurse and/or Allied...