Open Rank Intermediate and Senior Research Services Clinical Sciences Professional (Days/Weekends)

University of Colorado•Aurora, CO

7d•Onsite

About The Position

The Department of Emergency Medicine and the Airways, Trauma, Lung Injury and Sepsis (ATLAS) Lab Research Program seeks motivated applicants for the position of Research Services Clinical Sciences Intermediate or Senior Professional for day shifts (between the hours of 7a-5p) during weekdays and weekends. A minimum of one weekend day shift is required for this posting. The research projects focus on critically ill and injured patients in the Emergency Department and Intensive Care Units, including trauma and medical patients. This position is responsible for both observational and interventional clinical trial study coordinator duties within the ATLAS lab for single-center and multicenter trials, including screening, consenting, enrolling, and other duties as described below. The Principal Investigator is Adit Ginde, MD, MPH, Professor and Vice Chair for Research, Department of Emergency Medicine.

Requirements

Intermediate Professional: Bachelor’s degree in any field
One (1) year clinical trials or related experience (Intermediate Professional)
Senior Professional: Bachelor’s degree in any field
Two (2) years clinical trials or related experience (Senior Professional)
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Applicants must be legally authorized to work in the United States without requiring sponsorship.
Applicants must be willing and able to work day shifts (between the hours of 7am-5pm) during weekdays and weekends
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

Nice To Haves

Intermediate Professional: Bachelor’s degree in science or health related field
Two (2) years of clinical trials experience (Intermediate Professional)
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) (Intermediate Professional)
Senior Professional: Bachelor’s degree in science or health related field
Three (3) years of clinical trials or related experience (Senior Professional)
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) (Senior Professional)

Responsibilities

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
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies (Intermediate Professional)
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies (Intermediate Professional)
Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives (Intermediate Professional)
Develops or assists with developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs) (Senior Professional)
Maintains subject level documentation and prepares documents, equipment and/or supplies (Senior Professional)
Assist with identifying issues related to operational efficiency and shares results with leadership (Senior Professional)
Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention (Senior Professional)
Serve as a resource and participate in study initiation and close out duties (Senior Professional)