Entry/Intermediate/Senior Clinical Science Professional

University of Colorado Anschutz Medical Campus

Department: School of Medicine Radiology General Operations

Job Title: Entry/Intermediate/Senior Clinical Science Professional

Position #:00827129 - Requisition #: 34777

Job Summary:

Entry/Intermediate/Senior 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. Entry/Intermediate/Senior Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Some Assignments will not move beyond the senior level.

Examples of Duties Performed

• 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 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
• 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

Additional examples of work performed:

• Recruits and pre-screens potential study participants and coordinates advertisements via social medial, flyers, etc.
• Manages study record in OnCore.
• Conducts the informed consent process and ensures proper documentation.
• Reviews protocol inclusion/exclusion criteria and confirms study eligibility.
• Assures protocol compliance and completes necessary records; maintains Standard Operating Procedures (SOPs).
• Accurately enters source data into the study database in a timely manner; reviews records after each visit for completeness and accuracy.
• Manages scheduling of participants, tracks subject participation, and runs study visits.
• Recognizes and tracks adverse events and serious events and promptly notifies appropriate parties.
• Attends lab and study team meetings.
• Collects and processes biological samples.
• Data entry and quality assurance reviews in REDCap and Excel.

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:

Onsite - this role is expected to work onsite and is located at Anschutz Medical Campus, Aurora, CO.

Why Join Us:

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.

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

Entry:

• Bachelor's degree in any field

Intermediate:

• Bachelor's degree in any field
• One (1) year clinical research or related experience

Senior:

• Bachelor's degree in any field
• Two (2) years clinical research or related experience

A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

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
• Three (3) years of clinical research or related experience
• Phlebotomy certification or equivalent or willing to obtain certification at our expense
• Experience or comfort with handling biohazardous materials such as human blood, urine, and saliva samples
• Familiarity with REDCap surveys and data entry
• Experience conducting human subjects research visits or eligibility screenings

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
• Ability to interpret and master complex research protocol information
• Strong communication and organizational skills
• Ability to work collaboratively with study staff, postdoctoral researchers, undergraduates, principal investigators, hospital, clinic and lab staff
• Ability to work occasional nights and weekends
• Proficiency in Microsoft Office Suite
• Ability to multitask and meet deadlines

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 addre

Questions should be directed to: Victoria Bress, Victoria.bress@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until the position is filled. For best consideration, apply by (09/17/24).

Anticipated Pay Range:

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

Entry Research Services Professional $47,743 - $60,729

Intermediate Research Services Professional $51,956 - 66,088

Senior Research Services Professional $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 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.