Description
University of Colorado | CU Anschutz Medical Campus

Division of Pulmonary Sciences and Critical Care Medicine

Official Title: Research Services Clinical Science Professional (Open Rank)

Working Title: Clinical Research Coordinator- Center for Lungs and Breathing (Open Rank: Entry-Senior Level)

Position #00793004 – Requisition #24393

* 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 – Accommodations may be granted for medical or religious reasons.Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.Consolidated/Central Services Administration – Accommodations may be granted for medical or religious reasons.

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 School of Medicine's Division of Pulmonary Sciences and Critical Care Medicine has an opening for a full-time University Staff (unclassified) Research Services Clinical Science Professional (Open Rank: Entry-Senior Level), serving as the Clinical Research Coordinator for the Center for Lungs and Breathing (CLB) at University of Colorado Hospital, assisting in conducting clinical trials and research projects for the CLB Program.

Jobs in the Research Services career family provide direct professional support of research activities.  Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal, and training. Clinical Sciences 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.

Entry Clinical Sciences Professional

Professionals at all levels are responsible for exercising discretion, analytical skill, personal accountability, and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying, and sharing knowledge directly related to a professional field. Clinical Sciences Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. At the entry level, duties are limited in scope and are performed with guidance and direction from other professionals and are performed in a training and development capacity. At the intermediate level, duties are less limited in scope and are performed independently with occasional guidance and direction from other professionals. Work at the senior level is performed fully independently.

Examples of Duties Performed

Clinical Research Development

• Serving as the clinical research coordinator for industry sponsored and investigator-initiated clinical trials
• Assisting in the Maintenance of a clinical research specimen biorepository
• Other projects as assigned

Research Regulatory Management

• Assist with all regulatory activities required to implement and maintain the clinical research endeavors as part of the CLB.

Other Duties

• Assist with and oversee the day-to-day operations of clinical trials and studies
• 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. 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)
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• Adhere to research regulatory standards
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures, and other regulatory guidelines
• 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

Additional Examples of work Performed:

• Collaborating with principal investigators, co-investigators to enroll clinical trial patients
• Conducting study visits
• Overall compliance with the policy and procedures for conducting good clinical trials
• Screening, consenting and enrolling study participants
• Collecting, processing, and storing samples for research
• Medication compliance tracking and coordinating protocol procedures
• Collect and report all patient reported adverse drug reactions and other serious adverse events
• Patient education and follow-up per protocol guidelines
• Routine meetings with monitors to reconcile data management issues
• Participation in investigator’s meetings
• Preparing and submitting compliance documentation for the institutional review board
• Submission to the Human Research Subjects Portal for UCH-RSS review and approval
• Maintenance of databases
• Abstracting data from patient charts and electronic medical records
• Service in the following areas:
• Clinical Research Advisory Forum (RAF)
• Clinical Research Coordinators Committee (CRC)
• Support with local PH awareness and fundraising event

Additional Duties, Senior Level:

• 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
• Assist with developing or develops 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
• Collect information to determine feasibility, recruitment, and retention strategies. 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 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.

Salary and Benefits:

The salary range (or hiring range) for Entry Level has been established at $44,403 to 56,481.

The salary range (or hiring range) for Intermediate Level has been established at $48,321 to 61,464.

The salary range (or hiring range) for Senior Level has been established at $52,239 to 66,448.

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 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@ucdenver.edu.

The University of Colorado Denver | 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 and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | 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.

Qualifications
Minimum Qualifications

Entry Clinical Science Professional:

• 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 Clinical Science Professional:

• 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 Clinical Science Professional:

• 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
• Clinical research or related experience
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• Prefer a minimum of two years’ experience with coordinating and managing administrative and clinical research activities.
• Advanced computer skills, particularly Microsoft Excel, PeopleSoft, and COGNOS.
• Knowledge and experience with IRB policies and procedures.

Competencies, Knowledge, Skills, and Abilities

• Requires independent judgment as well as self-directed work capabilities.
• This position requires extensive experience with managing multiple projects and someone who can effectively multi-task
• Ability to establish work priorities and handle multiple deadlines.
• 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
• Ability to interpret and master complex research protocol information

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jun 8, 2022
Unposting Date: Ongoing