Coordinate initial and ongoing IRB approvals for assigned studies * Maintain regulatory ... No nights, weekends, or holidays. Comprehensive benefits package. Join Us If you are detail ...
Coordinate initial and ongoing IRB approvals for assigned studies * Maintain regulatory ... No nights, weekends, or holidays. Comprehensive benefits package. Join Us If you are detail ...
Coordinate initial and ongoing IRB approvals for assigned studies * Maintain regulatory ... No nights, weekends, or holidays. Comprehensive benefits package. Join Us If you are detail ...
Coordinate initial and ongoing IRB approvals for assigned studies * Maintain regulatory ... No nights, weekends, or holidays. Comprehensive benefits package. Join Us If you are detail ...
Clinical Research Coordinator I - Gait and Motion Analysis
Saint Paul, MN ยท On-site
$28.90 - $43.36/hr
... hours (some weekends may be required). This position will be based out of the 205 University ... Completes IRB application and amendments, continuing reviews, and other study related documents ...
Clinical Research Coordinator I - Gait and Motion Analysis
Saint Paul, MN ยท On-site
$28.90 - $43.36/hr
... hours (some weekends may be required). This position will be based out of the 205 University ... Completes IRB application and amendments, continuing reviews, and other study related documents ...
Clinical Research Coordinator I - Gait and Motion Analysis
$28.90 - $43.36/hr
... hours (some weekends may be required). This position will be based out of the 205 University ... Completes IRB application and amendments, continuing reviews, and other study related documents ...
Clinical Research Coordinator I - Gait and Motion Analysis
$28.90 - $43.36/hr
... hours (some weekends may be required). This position will be based out of the 205 University ... Completes IRB application and amendments, continuing reviews, and other study related documents ...
Clinical Research Nurse - Human Nutrition Research Center on Aging
Boston, MA ยท On-site
$79.60K - $119.50K/yr
... IRB). What You'll Do This is a part-time position at 21 hours per week. Salary is prorated based on ... May need to provide evening, weekend, and/or overnight coverage as indicated by protocol and unit ...
Clinical Research Nurse - Human Nutrition Research Center on Aging
Boston, MA ยท On-site
$79.60K - $119.50K/yr
... IRB). What You'll Do This is a part-time position at 21 hours per week. Salary is prorated based on ... May need to provide evening, weekend, and/or overnight coverage as indicated by protocol and unit ...
Clinical Research Coordinator
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator-Full-time-Onsite
Teaneck, NJ ยท On-site
$26 - $34.75/hr
Completing IRB required human subjects protection training (in addition to any other sponsor required training) * Complying with all IRB decisions, conditions and requirements * Capturing and ...
Clinical Research Coordinator-Full-time-Onsite
Teaneck, NJ ยท On-site
$26 - $34.75/hr
Completing IRB required human subjects protection training (in addition to any other sponsor required training) * Complying with all IRB decisions, conditions and requirements * Capturing and ...
Clinical Research Associate 1
$60.41K - $65K/yr
The CRA I will interact daily with clinicians, sponsors, IRB, regulatory agencies and other ... Occasional evenings and weekends Message to Applicants: Salary range-$60,406-$65,000 Recruitment ...
Clinical Research Associate 1
$60.41K - $65K/yr
The CRA I will interact daily with clinicians, sponsors, IRB, regulatory agencies and other ... Occasional evenings and weekends Message to Applicants: Salary range-$60,406-$65,000 Recruitment ...
Clinical Research Coordinator
Cincinnati, OH ยท On-site
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator
Cincinnati, OH ยท On-site
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator
Cincinnati, OH ยท On-site
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator
Cincinnati, OH ยท On-site
$23.25 - $31/hr
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with ...
Clinical Research Coordinator-Full-time-Onsite
Teaneck, NJ ยท On-site
$26.75 - $35.50/hr
Completing IRB required human subjects protection training (in addition to any other sponsor required training) * Complying with all IRB decisions, conditions and requirements * Capturing and ...
Clinical Research Coordinator-Full-time-Onsite
Teaneck, NJ ยท On-site
$26.75 - $35.50/hr
Completing IRB required human subjects protection training (in addition to any other sponsor required training) * Complying with all IRB decisions, conditions and requirements * Capturing and ...
... IRB, IACUC, biosafety). * Excellent written and verbal communication skills. WORK SCHEDULE: This position may occasionally be required to work weekends.
... IRB, IACUC, biosafety). * Excellent written and verbal communication skills. WORK SCHEDULE: This position may occasionally be required to work weekends.
This role supports investigators, sponsors, and internal teams by ensuring adherence to FDA, IRB, and GCP regulations throughout the study lifecycle. Key Responsibilities * Prepare, submit, and ...
This role supports investigators, sponsors, and internal teams by ensuring adherence to FDA, IRB, and GCP regulations throughout the study lifecycle. Key Responsibilities * Prepare, submit, and ...
Prepares, submits, and maintains IRB related documents.Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system. * Confirm all investigators, staff and ...
Prepares, submits, and maintains IRB related documents.Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system. * Confirm all investigators, staff and ...
... IRB, IACUC, biosafety). * Excellent written and verbal communication skills. WORK SCHEDULE: This position may occasionally be required to work weekends. * Conducts advanced, mentored research in ...
... IRB, IACUC, biosafety). * Excellent written and verbal communication skills. WORK SCHEDULE: This position may occasionally be required to work weekends. * Conducts advanced, mentored research in ...
Prepares, submits, and maintains IRB related documents.Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system. * Confirm all investigators, staff and ...
Prepares, submits, and maintains IRB related documents.Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system. * Confirm all investigators, staff and ...
Clinical Research Nurse
Tampa, FL ยท On-site
Screening, study recruitment, preparation of IRB reports * Establishment and maintenance of ... Yes Shift Hours: 8:00AM - 4:30PM Weekend Work: None Equal Opportunity Employer Veterans/Disabled
Clinical Research Nurse
Tampa, FL ยท On-site
Screening, study recruitment, preparation of IRB reports * Establishment and maintenance of ... Yes Shift Hours: 8:00AM - 4:30PM Weekend Work: None Equal Opportunity Employer Veterans/Disabled
No Weekend or Holiday Commitment Incentives & Benefits: TriHealth offers a comprehensive benefits ... Complies with all IRB/IACUC/FDA requirements in study submission to a central or local IRB.
No Weekend or Holiday Commitment Incentives & Benefits: TriHealth offers a comprehensive benefits ... Complies with all IRB/IACUC/FDA requirements in study submission to a central or local IRB.
Clinical Research Specialist
Pittsburgh, PA ยท On-site
Essential Functions Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Recruits research subjects and conducts interviews and research ...
Clinical Research Specialist
Pittsburgh, PA ยท On-site
Essential Functions Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Recruits research subjects and conducts interviews and research ...
Weekend Irb information
What are the key skills and qualifications needed to thrive as an IRB (Institutional Review Board) member, and why are they important?
What are the typical responsibilities of a Weekend IRB member, and how do they contribute to the review process?
What are Weekend IRB jobs?
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.
Regulatory Affairs Associate - Full Time - Germantown, TN
West Cancer CenterGermantown, TN โข On-site
Full-time
Posted 3 days ago
Job description
About Us
At West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research. Our team fosters collaboration, innovation, and professional growth, ensuring that every role contributes to making a difference in patients' lives. Join us in our mission to provide comprehensive support to those navigating the challenges of cancer treatment.
Position Overview
The Regulatory Affairs Associate I works closely with Sponsors, CROs, investigators, and research staff to coordinate regulatory submissions and approvals for multiple studies. This role is responsible for managing Institutional Review Board (IRB) submissions, maintaining regulatory documentation, processing safety reports, and ensuring compliance with federal regulations while supporting ongoing research activities.
Key Responsibilities
- Coordinate initial and ongoing IRB approvals for assigned studies
- Maintain regulatory responsibility for multiple studies
- Collect and maintain site-specific regulatory documents (CVs, licenses, lab certifications, FDA Form 1572, delegation logs, etc.)
- Prepare and submit study documents to IRB, Sponsors, and/or FDA as appropriate
- Maintain study binders with required documents and correspondence
- Meet study deadlines and coordinate with staff for subject information needed for updates and re-approvals
- Perform study closeout activities as appropriate
- Maintain essential regulatory documents
- Obtain IRB approval for updated study documents (protocol amendments, informed consent forms, Investigator Brochures, patient materials, etc.)
- Manage site changes including regulatory updates and documentation
- Process safety reports
- Maintain working knowledge of federal regulations
- Participate in Sponsor/CRO monitoring visits and audits
- Assist with report compilation, quality control of regulatory documents, and other assigned tasks
- Maintain professionalism and confidentiality in all interactions
- Assist with training and orientation of new employees
- Interface with external partners including sites, sponsors, CROs, IRBs, and FDA
- Perform all other duties as assigned
Qualifications
Education & Experience
Required:
- Two (2) years of regulatory affairs or research experience
Preferred:
- Associate's or Bachelor's degree
- Research certification
Skills & Abilities
- Strong organization and follow-up skills
- Excellent verbal and written communication skills
- Familiarity with Code of Federal Regulations and Good Clinical Practice (GCP)
- Strong problem-solving skills
- Ability to organize and prioritize work assignments
- Ability to manage multiple priorities in a fast-paced environment
- Ability to analyze situations and respond in a timely manner
- Ability to work in multi-functional teams
- Proficiency in computer applications including Word, Excel, Adobe Acrobat, email, and internet research
Why West Cancer Center is a Great Place to Work
- Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.
- Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
- Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.
- Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.
No nights, weekends, or holidays. Comprehensive benefits package.
Join Us
If you are detail-oriented and passionate about supporting clinical research and regulatory compliance, we invite you to join West Cancer Center as a Regulatory Affairs Associate I and contribute to advancing innovative cancer care.
About West Cancer Center
Sourced by ZipRecruiter
Company size
201 - 500 Employees
Headquarters location
Brighton, TN, US
Year founded
1979