Research Services Senior Professional

cu; Aurora (CO); Hybrid; AUD 84,000 - 112,000; Full time

Benefits offered by this job

Tuition Benefit

Hybrid work model

Job summary

University of Colorado Anschutz Medical Campus is seeking a Research Services Senior Professional to independently coordinate and manage clinical research studies involving human participants. You will work with patients, investigators and sponsors to ensure studies are conducted safely, efficiently and in compliance with regulatory requirements.

The role includes overseeing enrollment, data management, regulatory submissions and audits.

Qualifications

• Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, or related field and 2 years clinical research experience.
• Advanced degree may substitute for experience if directly related to work assignment.

Responsibilities

• Coordinate and manage clinical trial enrollment activities including screening and informed consent.
• Serve as primary contact for assigned trials with physicians, sponsors and departments.
• Oversee study operations: collection, processing, and shipment of specimens; develop tools and source documents.
• Maintain accurate research records in CRFs, databases and source documentation.
• Monitor participant safety and protocol compliance; track adverse events and data.
• Support regulatory submissions, audits and sponsor communications.

Skills

Clinical research

Communication

Regulatory knowledge

GCP/IRB knowledge

Data management

Education

Bachelor’s degree in related field

2 years clinical research experience

Tools

EMR/EHR systems

Source documents

Job description

University of Colorado Anschutz Medical Campus

Department: Department of Obstetrics & Gynecology, Division of Gynecologic Oncology

Job Title: Research Services Senior Professional

Position #: 00850257 - Requisition #:40394

Job Summary:

This is an exciting opportunity for a clinical research professional to play a key role in advancing innovative healthcare discoveries and improving patient outcomes. As a Senior Clinical Science Professional, you will independently coordinate and manage clinical research studies involving human participants, contributing to important therapeutic interventions, clinical trials, and emerging medical technologies. In this highly collaborative role, you will work directly with patients, investigators, sponsors, and multidisciplinary healthcare teams to ensure studies are conducted safely, efficiently, and in compliance with regulatory requirements.

The position is vital to the department's research mission and supports the university's commitment to advancing scientific knowledge and improving healthcare delivery. On a day-to-day basis, you will oversee participant enrollment, manage study data and documentation, coordinate protocol-required procedures, monitor participant safety, collaborate with sponsors and regulatory partners, and support audits and compliance activities. Your work will directly contribute to the successful execution of clinical research studies and help bring new treatments and innovations closer to the patients who need them most.

Key Responsibilities:

• Coordinate and manage clinical trial enrollment activities, including participant screening, eligibility verification, informed consent, education, and scheduling of study visits and required clinical services.
• Serve as the primary point of contact for assigned clinical trials, collaborating with physicians, nurses, sponsors, and hospital departments to ensure protocol compliance and participant support.
• Oversee study operations, including collection, processing, documentation, and shipment of research specimens, as well as development of study-specific tools and source documents.
• Maintain accurate and complete research records by collecting, reviewing, and entering study data into case report forms, databases, and source documentation in accordance with protocol and regulatory requirements.
• Monitor participant safety and study compliance by assessing eligibility, tracking adverse events, reviewing laboratory and test results, and ensuring all required procedures and data points are completed and documented.
• Manage sponsor communications, monitoring visits, data queries, enrollment logs, audits, and billing-related activities to support the successful execution of clinical research studies.
• Support regulatory compliance through adverse event reporting, regulatory submissions, training maintenance, and adherence to FDA, IRB, sponsor, and institutional requirements.

Work Location:

Hybrid – Eligible for a hybrid schedule of 3 days per week on campus and as needed for study activities. Potential for schedule to be 5 days a week on campus based on needs of business.

Why Join Us:

The University of Colorado, Department of Obstetrics & Gynecology’s, Division of Gynecologic Oncology is a women's health oncology practice dedicated to treating, curing and providing support for reproductive cancers. As the only National Comprehensive Cancer Network in the rocky mountain region, CU's Gynecologic Oncology group provides patients with the highest level of expertise available delivered in compassionate and individualized care.

Why work for the University?

We haveAMAZINGbenefits 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: 15/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:

• Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, or a directly related field from an accredited institution and 2 years of professional experience in clinical research.
  • An advanced degree (Masters orDoctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Experience with Phase I clinical research trials
• Experience serving as a primary coordinator for clinical trials
• One of the below certifications
  • CCRC – Certified Clinical Research Coordinator
  • CCRP – Certified Clinical Research Professional
  • CCRA – Certified Clinical Research Associate
• Spanish Fluency
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Conditions of Employment:

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.
• Eligible for a hybrid schedule of 4 days per week on campus and as needed for study activities. Potential for schedule to be 5 days a week on campus based on needs of business.

Knowledge, Skills and Abilities:

• 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, medical terminology
• Advanced knowledge of GCP, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions
• Proficient with Clinical Research Coordinator duties/responsibilities
• Excellent interpersonal and customer service skills
• Excellent oral and written communication skills
• Organization and time management skills
• Leadership abilities
• Ability to work on multiple research studies simultaneously
• Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with National Cancer Institute (NCI) sponsored, private industry and investigator initiated clinical trials
• Ability to interpret and master complex research protocol information

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as

$58,705 - $78,665

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

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination 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, including protected veterans and individuals with disabilities.

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 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.