Clinical Trials Coordinator (Intermediate – Senior Level)

Job Summary:

The Research Services Clinical Science Professional (Intermediate – Senior Level) - Clinical Trials Coordinator is a full-time position within the Department of Medicine, Division of Rheumatology. This position will be part of a team that conducts investigator-initiated and industry-sponsored clinical trials focused on autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, and other related autoimmune inflammatory diseases at the University of Colorado Anschutz Medical Campus. This position will play an important role in the ongoing development of this growing program. This position will take a lead in clinical trials using chimeric antigen receptor T-cell (CAR-T) therapies in autoimmune diseases.

The Clinical Trials Coordinator will be responsible for the overall organization and implementation of assigned study protocols/clinical trials, including study start-up, subject recruitment, screening, consenting, and coordination of study procedures and data collection. This position will also be responsible for managing the regulatory activities of the protocols, including submission and maintenance of documents for IRB, hospitals, and sponsors, as specified by the protocol and reporting requirements. They will serve as the liaison between sponsors, investigators, and study subjects.

Key Responsibilities:

• Research coordinator for industry sponsored clinical trials in rheumatologic or other related rheumatologic inflammatory disease, with a primary focus on CAR-T trials.
• Ensures compliance with Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), Good Clinical Practice (GCP), Institutional Review Boards (IRB), Health Insurance Portability and Accountability Act (HIPAA), University of Colorado Hospital (UCH), University of Colorado Denver (UCD) and other pertinent regulatory agencies.
• Performs subject recruitment, screening, consenting, coordination of clinical visits/protocol procedures and data collection and data entry and query resolution.
• Collaborates with investigators, clinical staff, and research staff to ensure study procedures are performed per protocol.
• Conducts medical record review, subject study visits and provides protocol specific subject education.
• Performs phlebotomy and pharmacokinetic sampling and collects basic clinical measurements, including vital signs. 

Work Location:

Onsite – this role is expected to work primarily onsite and is located in Aurora, CO

Why Join Us:

The Division of Rheumatology has a strong clinical research program that includes an expanding clinical trials program and highly impactful observational studies led by investigators who are leading experts in the field. Our clinical trials program is dedicated to bringing cutting-edge advances in treatments to our patients, including the potential for CAR-T therapies to revolutionize the treatment of patients with autoimmune diseases. Team members are part of a cohesive and collaborative team dedicated to having a positive impact on individuals suffering from the complications of autoimmune diseases. 

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness .

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

Intermediate Level:

• 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 clinical research or related experience.

Senior Level:

• 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.
• Two (2) years clinical research or related experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelor’s degree in science or health related field.
• Two (2) to three (3) years clinical research or related experience.
• Experience with clinical trials in oncology, hematology or using CAR-T or cellular based therapy.
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
• Experience working in OnCore.
• SOCRA or ACRP certification.
• Phlebotomy experience.

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.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Ability to move projects forward and get various groups of people working together for shared outcomes.

How to Apply:

For full consideration, please submit the following document(s):

1.     A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.

2.     Curriculum vitae / Resume

3.     Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.

Questions should be directed to: Prakriti Joshee, [email protected]  

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by April 24, 2024.

Anticipated Pay Range:

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

Intermediate Level: $51,956 - $60,788

Senior Level: $56,169 - $71,447

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

ADA Statement:

The University will provide reasonable accommodation 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 [email protected] ​.

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 .