IRB Submissions: Prepare, submit, and track initial protocols, amendments, continuing reviews, and safety reports to the IRB. * Regulatory Documentation: Maintains organized records of all regulatory ...
IRB Submissions: Prepare, submit, and track initial protocols, amendments, continuing reviews, and safety reports to the IRB. * Regulatory Documentation: Maintains organized records of all regulatory ...
Research Regulatory Specialist - National Center for Clinical Trials (NCCT)
Milwaukee, WI · Hybrid
$30.70 - $46.05/hr
Responsibilities include the preparation, review and submission of required regulatory documents to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other regulatory ...
Research Regulatory Specialist - National Center for Clinical Trials (NCCT)
Milwaukee, WI · Hybrid
$30.70 - $46.05/hr
Responsibilities include the preparation, review and submission of required regulatory documents to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other regulatory ...
Clinical Research Coordinator I - Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
... weekends. Primary Responsibilities * Recruit, screen, enroll and obtain consent from program ... Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the ...
Clinical Research Coordinator I - Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
... weekends. Primary Responsibilities * Recruit, screen, enroll and obtain consent from program ... Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the ...
Clinical Research Coordinator II - OBGYN
Milwaukee, WI · On-site
$24 - $31.75/hr
Occasional overnight (9:00 PM-7:00 AM) and weekend shifts may be required to accommodate study ... Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with ...
Clinical Research Coordinator II - OBGYN
Milwaukee, WI · On-site
$24 - $31.75/hr
Occasional overnight (9:00 PM-7:00 AM) and weekend shifts may be required to accommodate study ... Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with ...
Clinical Research Coordinator II - OBGYN
Milwaukee, WI · On-site
$24 - $31.75/hr
Occasional overnight (9:00 PM-7:00 AM) and weekend shifts may be required to accommodate study ... Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with ...
Clinical Research Coordinator II - OBGYN
Milwaukee, WI · On-site
$24 - $31.75/hr
Occasional overnight (9:00 PM-7:00 AM) and weekend shifts may be required to accommodate study ... Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with ...
Clinical Research Coordinator I - Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
... weekends. Primary Responsibilities * Recruit, screen, enroll and obtain consent from program ... Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the ...
Clinical Research Coordinator I - Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
... weekends. Primary Responsibilities * Recruit, screen, enroll and obtain consent from program ... Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the ...
Clinical Research Coordinator
$24 - $31.75/hr
Coordinate activities for the Institutional Review Board (IRB). * Prepare and maintains documents, presentations, files, training materials and databases needed for IRB compliance. What minimum ...
Clinical Research Coordinator
$24 - $31.75/hr
Coordinate activities for the Institutional Review Board (IRB). * Prepare and maintains documents, presentations, files, training materials and databases needed for IRB compliance. What minimum ...
Coordinate activities for the Institutional Review Board (IRB). * Prepare and maintains documents, presentations, files, training materials and databases needed for IRB compliance. What minimum ...
Coordinate activities for the Institutional Review Board (IRB). * Prepare and maintains documents, presentations, files, training materials and databases needed for IRB compliance. What minimum ...
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatric Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatric Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatric Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatric Emergency Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatrics
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatrics
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatrics
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Pediatrics
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Surgery
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Surgery
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator - Full Time
Janesville, WI · On-site
$27.17 - $42.11/hr
Prepare IRB documents and reports; ensure compliance with relevant IRB policies and regulatory agency requirements. (i.e.: continuing reviews or study updates) * Organize and maintain study documents ...
Clinical Research Coordinator - Full Time
Janesville, WI · On-site
$27.17 - $42.11/hr
Prepare IRB documents and reports; ensure compliance with relevant IRB policies and regulatory agency requirements. (i.e.: continuing reviews or study updates) * Organize and maintain study documents ...
Clinical Research Coordinator I - Surgery
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Surgery
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
Clinical Research Coordinator I - Department of Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
New
Clinical Research Coordinator I - Department of Medicine
Milwaukee, WI · On-site
$24 - $31.75/hr
Assure compliance with all relevant IRB and other regulatory agency requirements. * Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
New
Weekend Irb information
What is the difference between Weekend IRB vs IRB Coordinator?
| Aspect | Weekend IRB | IRB Coordinator |
|---|---|---|
| Certifications | Often requires IRB-related training, but not always formal certifications | Typically requires IRB or research compliance certifications |
| Work Environment | Part-time, flexible hours, often on weekends or evenings | Full-time, office-based, regular weekday schedule |
| Employer & Industry | Research institutions, hospitals, universities | Research institutions, hospitals, universities |
Weekend IRB roles focus on providing oversight during non-standard hours, often with flexible schedules, while IRB Coordinators handle ongoing compliance, documentation, and communication during regular hours. Both roles are essential in research oversight but differ mainly in work hours and specific responsibilities.
What is a weekend IRB?
What are the typical responsibilities of a weekend IRB member?
What are the key skills and qualifications needed to thrive as a weekend IRB member?
ThedaCare rating
6.6
Based on 128 frontline employees who took The Breakroom Quiz
569th of 887 rated healthcare providers
Job description
Living A Life Inspired!
Our new vision at ThedaCare is bold, ambitious, and ignited by a shared passion to provide outstanding care. We are inspired to reinvent health care by becoming a proactive partner in health, enriching the lives of all and creating value in everything we do. Each of us are called to take action in delivering higher standards of care, lower costs and a healthier future for our patients, our families, our communities and our world.
At ThedaCare, our team members are empowered to be the catalyst of change through our values of compassion, excellence, leadership, innovation, and agility. A career means much more than excellent compensation and benefits. Our team members are supported by continued opportunities for learning and development, accessible and transparent leadership, and a commitment to work/life balance. If you're interested in joining a health care system that is changing the face of care and well-being in our community, we encourage you to explore a future with ThedaCare.
Benefits, with a whole-person approach to wellness -
- Lifestyle Engagement
- e.g. health coaches, relaxation rooms, health focused apps (Wonder, Ripple), mental health support
- Access & Affordability
- e.g. minimal or zero copays, team member cost sharing premiums, daycare
About ThedaCare!
Summary :
The Research Regulatory Coordinator manages compliance, documentation, and submissions for clinical trials and human subject's research. This role acts as the primary liaison between clinical investigators, institutional review boards (IRBs), and study sponsors. The ideal candidate will ensure all research activities strictly adhere to federal, state, and institutional guidelines.
Job Description:
Essential Duties and Responsibilities
- IRB Submissions: Prepare, submit, and track initial protocols, amendments, continuing reviews, and safety reports to the IRB.
- Regulatory Documentation: Maintains organized records of all regulatory submission, approvals, and correspondence with regulatory bodies; maintains master regulatory binders (paper and electronic) ensuring audit-ready status at all times.
- Study Startup: Coordinate the collection, maintenance and storage of essential documents, including investigator CVs, medical licenses, financial disclosure forms, and organization required trainings.
- Compliance Monitoring: Maintain knowledge of current federal, state, and organizational regulations, guidelines, and industry standards related to research and ensures research activities comply with federal, state, and organizational regulations related to human subject research.
- Protocol Review & Study Tracking: Assist in the review of research protocols to ensure compliance with regulatory standards. Monitors study timelines as outlined with the sponsor and protocol.
- Trains & Supports: Acts as a resource for researchers, research office staff, learners and residents regarding regulatory process and documentation standards.
- Communicates & Works Collaboratively: Serves as the central point of contact for researchers, sponsors, contract research organizations (CROs), IRB, regulatory bodies and stakeholders.
- Audit & Monitor Visit Preparation: Assist with internal quality assurance audits, post approval monitoring and external inspections by federal agencies or sponsors.
Required Qualifications
- Education: Bachelor's degree in healthcare administration, life sciences, public health, or a related field.
- Experience: Minimum of 2 years of direct experience in clinical research, research regulatory affairs or IRB administration.
- Knowledge: Strong understanding of FDA regulations, HHS human subject protections (45 CFR 46), and ICH/GCP guidelines.
Preferred Qualifications
- One or more of the following preferred and/or able to obtain within 6 months of hire: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified Institutional Review Board Professional (CIP).
- Technology: Proficiency with data management platforms for the submission of Case Report Forms, electronic IRB submission portals, and safety reporting.
- Audit Readiness and Post Approval Monitoring: Direct experience preparing for and participating in successful FDA audits, sponsor inspections, post-approval monitoring or quality assurance audits and site visits.
Scheduled Weekly Hours:
40Scheduled FTE:
1Location:
ThedaCare Regional Medical Center - Neenah - Neenah,WisconsinOvertime Exempt:
NoWorker Shift Details:
Days
What ThedaCare employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About ThedaCare
Sourced by ZipRecruiter
We want to make exceptional care effortless for our patients. At ThedaCare, that means going above and beyond treating a particular condition – it means helping you achieve better health for life. You and your family are at the center of everything we do, from prioritizing your schedule when making appointments to designing our facilities for your comfort and convenience. Remaining proactive in your care allows us to better predict and prevent disease before complications arise, and when it comes to making important health-related decisions, we are here to support you. In every interaction, we want you to have full confidence the care you receive is purposeful, cost-effective and will help you continue enjoying life as you’ve planned it. ThedaCare is the third largest healthcare employer in Wisconsin, and the largest employer in Northeast Wisconsin with over 7,000 team members.
Industry
Health care and social assistance
Company size
5,001 - 10,000 Employees
Headquarters location
Neenah, WI, US
Year founded
1909