Clinical Research Point Coordinator

$51,956 - $66,088/Yr

University of Colorado - Aurora, CO

Full-time - Entry Level

Hybrid - Aurora, CO

Educational Services

About the position

The Clinical Research Support Team (CReST) at the University of Colorado Anschutz Medical Campus is seeking a full-time Intermediate Clinical Research Point Coordinator. This role is pivotal in providing regulatory, study coordination, and data collection/entry support for a diverse range of drug, device, and biologic studies conducted at the university and its affiliate hospitals. The coordinator will have the opportunity to act as a lead or co-lead for assigned studies, overseeing coordination activities and serving as a primary contact for training and guidance for junior coordinators. This position requires independent decision-making and project management responsibilities, necessitating a solid understanding of Good Clinical Practice (GCP) and Good Documentation Practices (GDP) in the context of clinical research. The ideal candidate will be collaborative, communicative, detail-oriented, and organized, with a proactive approach to problem-solving and a strong focus on quality. A passion for research and a commitment to personal growth are essential traits for success in this role. The coordinator will engage in frequent direct patient contact, ensuring ethical standards are upheld while protecting the rights and welfare of study participants. This position is designed for individuals who are motivated and dedicated to advancing clinical research and improving patient outcomes. The role is structured around three key areas of responsibility: Study Coordination (60%), CReST Support (20%), and Investigator Support (20%). The coordinator will independently perform study-related processes, conduct clinical research visits, recruit study participants, and ensure compliance with regulatory standards. Additionally, they will assist in study startup activities, mentor junior coordinators, and serve as a liaison between investigators, sponsors, and study subjects. This hybrid position allows for a flexible work schedule, with four days per week on campus and additional in-person meetings as needed.

Responsibilities

• Independently performs study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
• Coordinates and conducts clinical research visits with potential and enrolled study participants.
• Recruits prospective subjects for a variety of research clinical trials and educates them on study details through phone contacts and personal interviews.
• Reviews protocol inclusion/exclusion criteria and confirms eligibility of subjects to participate in clinical trials.
• Performs informed consent process or ensures that it has occurred and is properly documented.
• Completes study startup activities from initial site selection through budget negotiation and regulatory approvals.
• Trains and mentors junior coordinators and serves as a reference point for questions and guidance.
• Acts as primary contact and/or liaison for investigators, sponsor representatives, and study subjects for assigned research studies.
• Participates in site initiation, closeout, and other ongoing research team meetings.
• Assures compliance with applicable regulations and departmental Standard Operating Procedures (SOPs).

Requirements

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
• 1 year of professional level experience working in human subjects' research.
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Nice-to-haves

• Prior experience with direct patient contact.
• Experience managing industry clinical research study startup at CU, including HSR portal and Proposals routing, and budget and calendar review.
• Experience creating CTRC orders.
• Clinical research drug and/or device study coordination experience.
• Lab and sample collection and processing experience.
• Research training: CITI, GCP, IATA, blood borne pathogens, Basic Life Support (BLS).

Benefits

• Medical: Multiple plan options
• Dental: Multiple plan options
• Disability, Life, Vision insurance
• Retirement 401(a) Plan: Employer contributes 10% of 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: Access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service