Regulatory Affairs Coordinator (Entry Senior Level)

Regulatory Affairs Coordinator (Entry – Senior Level) – 35195 University Staff

Description

University of Colorado Anschutz Medical Campus

School of Medicine | Department of Medicine | Division of Hematology

Job Title: Regulatory Affairs Coordinator (Entry – Senior Level)

Position: #00828266 – Requisition: #35195

Job Summary:

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

Why Join Us:

Why work for the University?

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

Diversity and Equity:

Qualifications:

Minimum Qualifications:

Bachelors degree in any field.

Bachelors degree in any field.

One (1) year clinical regulatory compliance or related experience.

Bachelors degree in any field.

Two (2) years clinical regulatory compliance or related experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

Bachelors 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.

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:

November 1 st , 2024

Anticipated Pay Range:

or hiring range

Entry Level: $50,996 – $64,867

Intermediate Level: $55,496 – $70,590

Senior Level: $59,996 – $76,314

or hiring range

ADA Statement:

Background Check Statement:

Vaccination Statement:

Qualifications

Job Category

Primary Location

Schedule

Posting Date

Unposting Date

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The University of Colorado School of Medicine, Department of Medicine, 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 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 Divisions clinical trial portfolio. 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 Regulatory Affairs Coordinator will ensure the 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 2 days per week on campus and as needed for in-person meetings.

Investigators in the Division of Hematologys 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. We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: There are many additional perks & programs with the CU Advantage (https://apptrkr.com/getredirect.php?id=5726518&targetURL=https://advantage.cu.edu/) .

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Entry Level: Intermediate Level: Senior Level: A combination of education and related technical/paraprofessional experience may be substituted for the bachelors degree on a year for year basis.

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, daniel.page@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5726518&targetURL=daniel.page@cuanschutz.edu)

Immediately and continues until the position is filled. For best consideration, apply by .

The starting salary range () for this position has been established as: The above salary range () represents the Universitys 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/getredirect.php?id=5726518&targetURL=http://www.cu.edu/node/153125)

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 hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5726518&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/getredirect.php?id=5726518&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/getredirect.php?id=5726518&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Hybrid Department: U0001 — Anschutz Med Campus or Denver – 20164 – SOM-MED-BoneMarrow Transplant : Full-time : Oct 15, 2024 : Ongoing Posting Contact Name: Daniel Page Posting Contact Email: daniel.page@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5726518&targetURL=daniel.page@cuanschutz.edu) Position Number: 00828266jeid-3a2f625c3648de4c9fe52f9401f31a88

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.