Open Rank (Entry – Senior) Research Services Clinical Science Professional

The University of Colorado is hiring an Open Rank Research Services Clinical Science Professional for the Department of Emergency Medicine. The role supports grant-funded studies focused on mental health and firearm storage, with an emphasis on lethal means safety in veteran and military populations, and includes clinical trial operations and research support.

Responsibilities

• Assist with and oversee the day to day operations of clinical trials and studies
• Review 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
• 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
• Conduct qualitative interviews
• Design surveys

Preferred

• 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)
• Three (3) years of clinical research or related experience
• Experience conducting qualitative interviews
• Experience with survey design
• Master's degree in psychology, public health, behavioral health, or a research-related discipline
• Strong interest or previous experience working in psychological health, public health, or behavioral health
• Electronic Data Capture
• EMR/EHR Systems
• Data Management Systems
• Qualitative Interviewing
• Survey Design
• Psychology
• Public Health
• Behavioral Health
• Interest in Behavioral Health

Benefits

• Hybrid schedule of 3 days per week on campus and as needed for in-person meetings.
• 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
• This position may be eligible for overtime compensation, depending on the level.

Company

• Public research university with four Colorado campuses
• Denver, Colorado, USA
• https://www.cu.edu/
• Founded in 1876
• 10001+ employees

Qualifications

• This position requires familiarity and experience with clinical or public health research, preferably in psychological health and/or behavioral health
• The ideal candidate will have experience within research (clinical or behavioral), collaborate effectively on multidisciplinary teams, and be highly detail oriented
• Bachelor's degree in any field
• One (1) year clinical research or related experience
• Two (2) years clinical research or related experience
• A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis
• An advanced degree (Masters or PhD) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment
• 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 medical terminology
• Ability to interpret and master complex research protocol information
• Excellent written and oral communication skills
• Excellent organizational and interpersonal skills
• Ability to think creatively, adapt quickly and work independently
• Excellent team player
• Self-starter with a desire to improve human health through research
• High Level Skills with Computer-Based Tools (Word, Outlook, PowerPoint, Etc.)
• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future
• 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)
• Three (3) years of clinical research or related experience
• Experience conducting qualitative interviews
• Experience with survey design
• Master's degree in psychology, public health, behavioral health, or a research-related discipline
• Strong interest or previous experience working in psychological health, public health, or behavioral health
• A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
• An advanced degree (Masters or PhD) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.

Required skills

• Behavioral Health, Clinical Practice (GCP), Clinical Research, Electronic Medical/Health Records (EMR/EHR), Federal Research Regulations, Human Anatomy, Medical Terminology, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Physiology, Psychological Health, Public Health, Qualitative Interviewing, Research Protocols, Survey Design

Preferred skills

• Bachelor's degree in science or health related field, Experience conducting qualitative interviews, Experience with survey design, Three (3) years of clinical research or related experience, Two (2) years of clinical research or related experience