Regulatory Affairs Coordinator (RAC) (Entry - Senior Level)

University of Colorado Anschutz Medical Campus; Aurora (CO, IL); Hybrid; USD 50,000 - 65,000; Full time

Job summary

An innovative institution is seeking a Regulatory Affairs Coordinator to support clinical trials and investigator-initiated studies. This role involves ensuring compliance with federal regulations and facilitating communication among various stakeholders, including Principal Investigators and regulatory bodies. The position offers a unique opportunity to contribute to groundbreaking research in hematology, working alongside a dedicated team committed to improving patient outcomes. Join a collaborative environment where your expertise will play a vital role in advancing clinical research and enhancing the lives of patients with blood cancers.

Benefits

Medical: Multiple plan options

Dental: Multiple plan options

Disability Insurance

Life Insurance

Vision Insurance

401(a) Retirement Plan

Paid Time Off

Vacation Days: 22/year

Sick Days: 15/year

Tuition Benefit

Qualifications

• Bachelor's degree required; science or health-related preferred.
• 1-3 years of clinical research or regulatory experience preferred.

Responsibilities

• Serve as regulatory contact for clinical research studies.
• Submit clinical research applications to regulatory bodies.
• Write informed consent documents and HIPAA Authorizations.

Skills

Regulatory Compliance

Clinical Research

Communication Skills

Customer Service

Knowledge of Federal Regulations

Education

Bachelor's degree in any field

Bachelor's degree in science or health-related field

Job description

University Staff

Description

University of Colorado Anschutz Medical Campus

School of Medicine | Department of Medicine | Division of Hematology

Job Title: Regulatory Affairs Coordinator (RAC) (Entry - Senior Level)

Position: #00833812 - Requisition: #36725

Job Summary:	The University of Colorado Division of Hematology, Clinical Trials Unit 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 Hematology. The Regulatory Affairs Coordinator (RAC) will work closely with the HCTU Leadership Team, Principal Investigators, Industry Sponsor/CRO Representatives, IRBs, and other departments on campus to provide support for the Division's clinical trial portfolio. This position will provide support for studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials and investigator-initiated studies. The RAC will ensure the accurate progress of clinical research from the planning and approval stages through study completion and post-study closure. Key Responsibilities: Serves as regulatory contact person for ongoing 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 records. Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado. This may include, but is not limited to, the following: Colorado Multiple Institutional Review Board (COMIRB) Protocol Review and Monitoring System (PRMS) Hospital Research Support Services (UCH-RSS) University of Colorado Hospital Biosafety Committee (IBC) University of Colorado Hospital Clinical Trials Research Center (CTRC) Writes clear and accurate subject informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations. Completes and submits continuing reviews, amendments, and safety updates as needed. Participates in Data Safety Monitoring Committee (DSMC) internal audits. Updates database with regulatory submission and approval dates.
Work Location:	Hybrid - this role is eligible for a hybrid schedule of two (2) days per week on campus and as needed for in-person meetings.
Why Join Us:	Investigators in the Division of Hematology's Blood Cancer Program are actively engaged in multiple research activities aimed at improving outcomes for patients with blood cancers and related disorders. These studies are wide-ranging and involve extensive collaboration between laboratory scientists and physicians. Our work is funded by the National Cancer Institute (NCI), the American Cancer Society (ACS), the Leukemia and Lymphoma Society (LLS), and numerous other foundations and industry sources. A key strength of our research group is its highly collaborative and cross-disciplinary nature, which provides an ideal environment in which to develop new therapies. The Hematology Clinical Trials Unit (HCTU) plays an integral role in conducting the clinical research components of the division and has made bringing bench-to-bedside research a huge divisional success. The HCTU is comprised of over 30 employees, and their dedication and investment each day is seen and felt by patients who have and will participate in a clinical trial. Why work for the University? We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: Medical: Multiple plan options Dental: Multiple plan options Additional Insurance: Disability, Life, Vision Retirement 401(a) Plan: Employer contributes 10% of your gross pay Paid Time Off: Accruals over the year Vacation Days: 22/year (maximum accrual 352 hours) Sick Days: 15/year (unlimited maximum accrual) Holiday Days: 10/year Tuition Benefit: Employees have access to this benefit on all CU campuses ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage.
Qualifications:	Minimum Qualifications: Entry Level: Bachelor's degree in any field. Intermediate Level: Bachelor's degree in any field. One (1) year of clinical regulatory compliance or related experience. Senior Level: Bachelor's degree in any field. Two (2) years of clinical regulatory compliance or related experience. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications: Bachelor's degree in science or health related field. One (1) to three (3) years of clinical research or related experience. 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. Knowledge of basic human anatomy, physiology, and medical terminology. Ability to interpret and master complex research protocol information.
How to Apply:	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: Daniel Page, [e-mail]
Screening of Applications Begins:	Immediately and continues until position is filled. For best consideration, apply by May 15th, 2025.
Anticipated Pay Range:	The starting salary range (or hiring range) for this position has been established as Entry Level: $50,996 - $64,867 Intermediate Level: $55,495 - $70,590 Senior Level: $59,995 - $76,314 The above salary range (or hiring 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
Equal Employment Opportunity Statement:	The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply.
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 [e-mail].
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. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:	CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. 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.

Qualifications

Application Materials Required:Cover Letter, Resume/CV, List of References

Job Category:Research Services

Primary Location:Hybrid

Department:U0001 -- Anschutz Med Campus or Denver-20164 - SOM-MED-BoneMarrow Transplant

Schedule:Full-time

Posting Date:Apr 28, 2025

Unposting Date:May 16, 2025, 5:59:00 AM

Posting Contact Name:Daniel Page

Posting Contact Email:[e-mail]

Position Number:00833812