Clinical Research Data Specialist

Job Summary:

The Clinical Research Data Specialist will be responsible for the management of clinical trials data for all protocols conducted at the Infectious Diseases Clinical Trials Unit. This includes evaluation of clinical trials data prior to entry into a centralized data management system; randomization of research participants to protocol specified treatments; tracking patient participation through systems developed locally; development and implementation of quality control mechanisms for ensuring data accuracy and completeness; acting as a liaison between the site and the central data management center for ensuring quality of data by resolving data queries, errors and submission of outstanding data in a timely manner.

Key Responsibilities:

• Assist with and oversee the day-to-day operations of clinical trials and studies.
• Responsible for data management for all clinical trials data.
• Develops protocol-specific source documents and organizes and prepares research materials for research study visits.
• Accurately and timely enters clinical trials data into centralized data management systems, ensures data quality and reviews participant records for completeness, accuracy, and quality.
• Reviews and resolves data discrepancies in data management systems.
• Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
• Independently performs study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
• Assists Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives.
• Adhere to research regulatory standards.
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities.
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives.

Work Location:

Onsite - this role is expected to work onsite and is located in Aurora, CO.

Why Join Us:

The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu.

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: 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.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in any field.
• One (1) year 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) years of clinical research or related experience.
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
• Experience with REDCap.

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, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Proficiency in Microsoft Office Suite.

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: Nicola Haakonsen, nicola.haakonsen@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until June 18^th, 2025.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $52,721 - $67,061.

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

Equal Employment Opportunity Statement:

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, 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 hr.adacoordinator@cuanschutz.edu.

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.