Research Services Senior Professional

University of Colorado•Hybrid, CO

1d•$58,705 - $78,665•Hybrid

About The Position

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.

Requirements

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.
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

Nice To Haves

Experience with Phase I clinical research trials
Experience serving as a primary coordinator for clinical trials
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)

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.