Clinical Sciences Entry Professional

University of Colorado•Aurora, CO

19h•Onsite

About The Position

This Clinical Sciences Entry Professional position is for an assistant study coordinator for the “CALICO and RESTORE” studies with Dr. Cree. These are longitudinal clinical trials in females with polycystic ovary syndrome or obesity. The position will encompass all aspects of the studies and be done independently, ranging from recruitment, consent, scheduling of study procedures, performance of study procedures, including processing of blood samples, data entry in Excel and REDCAP, utilization of ACTi pal, and specialized blood pressure assessments. Also, coordination and onboarding of other clinical sites for the CALICO Database.

Requirements

Bachelor’s degree in any field.
Applicants must meet minimum qualifications at the time of hire.
Must successfully pass a drug test through Children’s Hospital Colorado.
Must be willing and able to pass a national criminal background check.
Fluent in Spanish and able to pass the Bilingual Staff Certificate.

Nice To Haves

Bachelor’s degree in biology, molecular biology, chemistry, genetics, or related field.
Six (6) months of previous experience in pediatric research.
Experience with using REDCAP database.
Knowledge of pipette and safe handling of blood products.
Demonstrated ability to learn new tasks quickly.
Demonstrated ability to work well with teams.
Very strong organizational skills.
Detail-oriented.
Experience with EPIC Electronic Medical Records.

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) across multiple sites and with multiple systems.
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, all pre-screening/screening activities, and treatments and/or study procedures.
Ensure that the necessary supplies and equipment for studies are in stock and in order.
Placement of continuous glucose monitor device on study participants, set-up monitoring on participants device and analysis of results.
Administrative coordination for CALICO database study including study meetings, progress notes, communications to sites, assistance with Calico related grants, assistance with Calico related manuscript submissions.
Processing and shipping of blood samples.