Clinical Research Services Professional

University of Colorado CU Anschutz Medical Campus

Department of Orthopedics

Research Services Entry Professional

Clinical Research Services Professional

Position #00803761 – Requisition #27964

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.  Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012—covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

• Anschutz Campus – Exemptions are allowed for medical or religious reasons.
• Denver Campus – Exemptions are allowed for medical, religious, or personal reasons.
• Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here .

  The Department of Orthopedics has an opening for a full-time University Staff Clinical Research Services Professional position.

This position will primarily work from the UCHealth Steadman Hawkins Clinic Denver. This orthopedic outpatient clinic hosts a variety of research projects and collaborates locally and nationally for other clinical trials. Research projects are typically related to the hip, knee, or shoulder. The position may include time spent collaborating with physical therapy and rehabilitation, and/or in our ambulatory surgery center with surgical patients. This position will primarily support research lead by Drs. James Genuario and Stephanie Mayer. 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.

Nature of Work

Clinical Science Professionals 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.

Examples of Duties Performed

All levels with increased independence at higher levels

Data Management/Data Entry (30%) including:

• Abstracts and records all patient data essential to the study onto required Case Report Forms (CRFs) and into the Clinical Trials database, as needed, in an accurate and timely fashion.
• Ensures complete source documentation is compiled in research records.
• Schedules and tracks submission of prescreening, screening and enrollment logs as required by study sponsor.
• Obtains and reviews the electronic medical records via EPIC for the identifying and screening of potential research subjects.
• Documents and maintains study records of research subjects including laboratory test results, all clinical and study procedures as well as standard of care visits as required per the study protocol.
• Documenting research notes into the EMR of participants.

Study Related Preparation and Execution of Study Procedures (50%) including:

• Gather and maintain source documents, regulatory binders, and subject binders.
• Ensure the current version of consent forms are completed, informed consent process in properly documented and filed.
• Review medical history to determine eligibility status.
• Schedules, coordinates, prepares for, and conducts sponsor monitor visits and audits in collaboration with the regulatory team, CRC and other team members.
• Meets with monitors to respond to any question of data validity and corrects/revises data as appropriate, answers queries from sponsoring companies.
• Conducts screening, study assessments, and follow-up of study patients as required per each study protocol.
• Recruits clinical study participants; coordinating and scheduling research appointments, interviews and evaluates potential participants, and develop and maintains accurate documentation of the progress of the research.

IRB Preparation and Management (10%) including:

• Develops and submits accurate IRB applications, Continuing Review Reports, and all other required documents to support the conduct of clinical trials research.

Other Clinical Research Duties (10%) including:

• Provides assistance to the PI, and Research Project Manager.
• Serves as backup to other divisional study coordinators.
• Maintains all proper certifications and trainings for the role of a clinical research coordinator.
• Attends meetings with team members, sponsors, and supervisor as requested.
• Any other tasks, as assigned by the supervisor.
• Assist with and oversee the day-to-day operations of clinical trials and studies.

This description is a summary only and is describing 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.

Minimum Qualifications

Entry 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.

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.

 Competencies, 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 medical terminology.

Preferred Qualifications

• Bachelor’s degree in science or health related field.
• One to Two (1-2) years of clinical research or related experience.
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).
• Human anatomy and physiology knowledge.
• Medical terminology.
• Basic statistical understanding and analyses development.

Required: Applicants must meet minimum qualifications at the time of hire.

Salary and Benefits

The salary range (or hiring range ) for this position has been established at $44,403-$56,481.

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty, and training.

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 is not eligible for overtime compensation.

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.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

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.

Review of applications will begin immediately and will continue until the position is filled.

PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.