Research Services Senior Professional

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 have AMAZING benefits and offer exceptional 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 or Doctorate) 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