- Complete and submit continuing reviews, amendments, and other protocol-specific documents for COMIRB studies.
- Tracks and maintains the most up-to-date medical licenses, Curricula Vitae (CVs), and Good Clinical Practice (GCP) certifications for study personnel.
- Complete and submit accurate federal forms, consents, HIPAA Authorizations, and obtain required approvals specific to the VA Medical Center.
- Update OnCore with regulatory documents and dates.
- Prepare and route essential regulatory documents for study start-up and study maintenance (medical licenses, CVs, GCP certifications, FDA 1572s, financial disclosure forms, laboratory certifications, signature pages, and other documents as needed).
- Participate in Data Safety Monitoring Committee (DSMC) internal audits.
- Draft IRB applications for COMIRB. Require the ability to read and interpret a research protocol and understand human subjects and HIPAA-protected data.
- A bachelor's degree in any field.
- A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
- One (1) year of regulatory compliance experience.
- Bachelor's degree in science or health-related field.
- Two (2) years of regulatory compliance experience.
- Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).
- Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills
- Demonstrated commitment and leadership ability to advance diversity and inclusion.
- Knowledge of basic human anatomy, physiology medical terminology
- Ability to interpret and master complex research protocol information.
- A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
- Curriculum vitae / Resume
- Three to five professional references including name, address, phone number (mobile number if appropriate), and email address
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Regulatory Affairs Coordinator - Aurora, United States - University of Colorado
Description
University of Colorado Denver l Anschutz Medical CampusDepartment of Medicine | Division of Gastroenterology & Hepatology
Official Title:
Research Services Regulatory Compliance Professional
Working Title:
Regulatory Affairs Coordinator - Gastroenterology & Hepatology
Position:
# Requisition: #29761
Job Summary:
The University of Colorado Division of Gastroenterology and Hepatology is seeking a Regulatory Affairs Coordinator.
This position is responsible for providing regulatory support for clinical trials and investigator-initiated studies for the division of gastroenterology and hepatology.
The regulatory affairs coordinator will work closely with the Regulatory Affairs Manager, Principal Investigators, Research Development Manager, the department's administration team, and other departments and centers on campus and hospitals and clinics.
The regulatory affairs coordinator will provide support for studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials and investigator-initiated studies.
The research affairs coordinator will ensure the accurate progress of clinical research from the planning and approval stages through study completion and post-study closure.
Key Responsibilities:
Why Join Us:
The University of Colorado's Division of Gastroenterology and Hepatology in the Department of Medicine, located at the Anschutz Medical Campus is an internationally renowned program that provides comprehensive resources for the diagnosis and therapy of diseases of the digestive tract, pancreas, and liver.
Division of Gastroenterology and Hepatology has faculty and staff making contributions to translational research, clinical trials, and nationally recognized patient care.
By joining our division, you would be joining a rapidly growing team, with clinical practices throughout the state of Colorado and over 80 researchers, physicians, and staff, all working toward its vision to prevent and treat disease while being a global model for patient care delivery, interdisciplinary research, and training.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more.
To see what benefits are available, please visit:
Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff.
Qualifications:
Minimum
Qualifications:
Preferred
Qualifications:
Knowledge, Skills, and Abilities:
How to Apply:
For full consideration, please submit the following document(s):
Questions should be directed to:
Trisha Loftin,
Screening of Applications Begins:
Screening of applications begins immediately and continues until the position is filled.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as $54,960 - $69,909.
The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator:
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors.
Vaccination Statement:
The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.
Anschutz:
Unit-Specific Exemptions:
Anschutz Campus - Accommodations may be granted for medical or religious reasons.
The University of Colorado seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.
