Clinical Research Coordinator (Head & Neck Team)

University of Colorado Anschutz; Aurora (CO); Hybrid; USD 49,899 - 58,705; Full time

Job summary

University of Colorado Anschutz Medical Campus is seeking a Clinical Research Coordinator for the Head & Neck Team within the Cancer Center. The role involves coordinating day-to-day clinical trial activities, data abstraction, subject eligibility, informed consent, and regulatory compliance.

The position offers a hybrid on-site arrangement at Anschutz Medical Campus, with opportunities to work with a multidisciplinary team, support recruitment efforts, and contribute to high-quality clinical

Qualifications

• Bachelor's degree required; substitution allowed with related experience.
• Experience with clinical research and regulatory compliance preferred.
• Ability to manage multiple tasks across trials and teams.

Responsibilities

• Oversee day-to-day operations of clinical trials.
• Abstract and enter subject data into CRFs and trials databases.
• Assess eligibility and obtain informed consent.
• Coordinate subject recruitment and scheduling visits.
• Ensure regulatory compliance and prepare audit responses.

Skills

GCP knowledge

Communication skills

Interpersonal skills

Attention to detail

Interpret complex study protocols

Education

Bachelor's degree in any field

Advanced degree (Masters/Doctorate) in related field

Tools

EMR/EHR systems

Data management systems

Job description

University of Colorado Anschutz Medical Campus

Department: Cancer Center - CCTO (Head & Neck Team)

Working Title: Clinical Research Coordinator (Head & Neck Team)

Position #: 00697685 - Requisition #: 40353

Job Summary

Clinical Science Professionals at all levels perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.

Key Responsibilities:

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Independently abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into clinical trials database in an accurate and timely fashion
• Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Interview prospective subjects for a variety of research clinical trials and educate potential subjects on the details of the studies through phone contacts and personal interviews
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Collaborate with other clinical research team members, investigators, and hospital staff to ensure tests and procedures required by research protocols are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures); follow up with appropriate persons on missing or discrepant data
• Meet with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
• Adhere to research regulatory standards
• Maintain detailed records of studies including Patient Source Document Binder to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order
• Schedules, coordinates, and prepares for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs, Primary CRC and other research team members

Entry Level or CRC I:

• Level of clinical or data focused tasks will be determined at the discretion of the supervisor/manager based on team needs.

Intermediate Level or CRC II, all the above and:

• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members

Senior Level or CRC III, all the above and:

• Assist with developing or develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
• Serve as a resource and participate in study initiation and close out duties

This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location

Hybrid - This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion.

Why Join Us

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

Why work for the University?

We have AMAZING benefits 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: 10/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.

To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness

Diversity and Equity

Equal Opportunity Employer. The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination 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.

Qualifications

Minimum Qualifications:

Entry Level or CRC I

• Bachelor's degree in any field
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis

Intermediate Level or CRC II

• Bachelor's degree in any field
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
• One (1) year of professional clinical research experience and/or professional clinical experience post Bachelor's degree

Senior Level or CRC III

• Bachelor's degree in any field
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
• One (1) year of professional clinical research experience and one (1) year of professional clinical research experience and/or professional clinical experience post Bachelor's degree
  • A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.

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 application.

Preferred Qualifications

• Bachelor's degree in science or health related field
• Three (3) years of clinical research or related experience
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• Additional certification (one of the following):
  • CCRC - Certified Clinical Research Coordinator
  • CCRP - Certified Clinical Research Professional
  • CCRA - Certified Clinical Research Associate

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.

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
• Knowledge of basic human anatomy, physiology medical terminology
• 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

• Level I (Entry): $49,899
• Level II (Intermediate): $54,302
• Level III (Senior): $58,705

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: http://www.cu.edu/node/153125

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 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.

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.