Job Information
University of Colorado Regulatory Affairs Coordinator in Aurora, Colorado
Regulatory Affairs Coordinator - 32463 University Staff
Description
University of Colorado Anschutz Medical Campus
School of Medicine | Department of Medicine | Division of Gastroenterology & Hepatology
Job Title: Regulatory Affairs Coordinator
Position: #00703444 – Requisition: #32463
Job Summary:
Key Responsibilities:
Responsible for high-level leadership to PI designated personnel and regulatory support staff for all regulatory submissions for GI-Hep investigators, as well as regulatory compliance of research activities within the department.
Responsible for independently advising on and generating complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Serves as regulatory liaison for ongoing and upcoming clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory boards.
Develops (or provides oversight of the development of) clear and accurate subject informed consent documents and HIPAA authorization documents for investigators.
Routes DUAs, MTAs, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
Assists research teams to develop appropriate monitoring plan and monitors data compliance, reporting findings to the PI and study team.
Maintains a comprehensive record keeping system of clinical research data and reports metrics of productivity on a monthly basis to DART leadership.
Creates and establishes divisional SOPs and guidelines to ensure regulatory policy is updated per institutional, state, and federal requirements.
Work Location:
Hybrid
Why Join Us:
Key Responsibilities:
Responsible for high-level leadership to PI designated personnel and regulatory support staff for all regulatory submissions for GI-Hep investigators, as well as regulatory compliance of research activities within the department.
Responsible for independently advising on and generating complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Serves as regulatory liaison for ongoing and upcoming clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory boards.
Develops (or provides oversight of the development of) clear and accurate subject informed consent documents and HIPAA authorization documents for investigators.
Routes DUAs, MTAs, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
Assists research teams to develop appropriate monitoring plan and monitors data compliance, reporting findings to the PI and study team.
Maintains a comprehensive record keeping system of clinical research data and reports metrics of productivity on a monthly basis to DART leadership.
Creates and establishes divisional SOPs and guidelines to ensure regulatory policy is updated per institutional, state, and federal requirements.
Work Location:
Hybrid
Why Join Us:
Diversity and Equity:
Qualifications:
Minimum Qualifications:
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.
Three (3) years of clinical regulatory compliance experience.
Preferred Qualifications:
Bachelor's degree in science or health-related field.
Research Certificate (SOCRA, ACRP, RAC, etc.).
Four (4) years of clinical regulatory compliance experience.
Experienced with Institutional Review Board (IRB Submission).
Knowledge, Skills, and Abilities:
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, and medical terminology.
Ability to interpret and master complex research protocol information.
How to Apply:
Screening of Applications Begins:
February 25 th , 2024
Anticipated Pay Range:
or hiring range $65,812 - $83,713
or hiring range
ADA Statement:
Background Check Statement:
Vaccination Statement:
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The Regulatory Affairs Coordinator is responsible for providing central management and regulatory oversight for clinical trials and investigator-initiated studies for The Division of Gastroenterology and Hepatology. This position will work closely with Principal Investigators, Research Development Manager, the department's administration team, and other departments and centers on campus and hospitals and clinics. This position will also provide support and leadership for studies that may involve industry-sponsored Phase I, II, III, IV clinical trials and investigator-initiated studies. The Regulatory Affairs Coordinator will ensure accurate progress of clinical research from the planning and approval stages through study completion and post-study closure.
– this role is eligible for a hybrid schedule of 3 - 4days per week on campus and as needed for in-person meetings.
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. The 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, holidays and more. To see what benefits are available, please visit: https://apptrkr.com/get_redirect.php?id=4968587&targetURL=Regulatory Affairs Coordinator is responsible for providing central management and regulatory oversight for clinical trials and investigator-initiated studies for The Division of Gastroenterology and Hepatology. This position will work closely with Principal Investigators, Research Development Manager, the department's administration team, and other departments and centers on campus and hospitals and clinics. This position will also provide support and leadership for studies that may involve industry-sponsored Phase I, II, III, IV clinical trials and investigator-initiated studies. The Regulatory Affairs Coordinator will ensure accurate progress of clinical research from the planning and approval stages through study completion and post-study closure.
– this role is eligible for a hybrid schedule of 3 - 4days per week on campus and as needed for in-person meetings.
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. The 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, holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position. 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address. Questions should be directed to: Trisha Loftin, trisha.loftin@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=trisha.loftin@cuanschutz.edu)
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by . Those who do not apply by this date may or may not be considered.
The starting salary range () for this position has been established as . The above salary range () represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. 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: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=http://www.cu.edu/node/153125)
The University will provide reasonable accommodation 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 hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=hr.adacoordinator@cuanschutz.edu) .
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .
Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20189 - SOM-MED-Gastroenterology : Full-time : Jan 26, 2024 : Ongoing Posting Contact Name: Trisha Loftin Posting Contact Email: trisha.loftin@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=4968587&targetURL=trisha.loftin@cuanschutz.edu) Position Number: 00703444jeid-66d94efb7d11bf428897bf46b791658a
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.