Clinical Research Coordinator

University of Colorado•Aurora, CO

27d•Onsite

About The Position

The Department of Psychiatry is seeking applicants for a full time (1.0 FTE) Clinical Research Coordinator (Research Services Clinical Science Professional). Candidates in this role will be integrated into the clinical trials arm of the Psychiatry Research Innovations unit (PRI), which is a research support center within the Department of Psychiatry that provides research assistance to faculty members affiliated with the five divisions in the Department. Candidates will also collaborate closely with the Brain and Behavior Innovation Center (BBICen), a newly created center within the Department which seeks to advance mental health innovation through three pillars including technology, therapeutics, and care re-design. Candidates in this role will perform duties common to a clinical research coordinator, providing direct professional support of daily research activities on drug and device trials, such as subject recruitment and management, screening, scheduling, conducting informed consent/assent/HIPAA activities, mental health assessments, fMRI scans, data and biological sample collection, and regulatory compliance activities. Candidates may also be asked to coordinate other types of studies including pre-clinical, pilot, or feasibility trials. Their extent of involvement in any of these research duties will be assigned by their supervisor. This individual will be responsible for collaborating with various faculty and staff across campus as well as in contact with study participants. The candidate should be organized, detail-oriented, professional in conduct, possess good interpersonal skills, a team player and capable of managing their responsibilities with minimal supervision.

Requirements

Bachelor's degree in any field. A combination of education and related technical/military/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.
Applicants must be legally authorized to work in the United States without requiring sponsorship.
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 and understanding of federal regulations and Good Clinical Practice (GCP).
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Demonstrated ability to think independently, problem solve, proactively resolve issues, and manage priorities.
Strong organizational skills and ability to multitask.
High level computer skills including expertise in Microsoft Office, Adobe, electronic forms, databases, and preparation of presentations and reports.

Nice To Haves

Bachelor's degree in science, psychology, or health related field.
Two (2) to three (3) years of clinical research or related experience.
Experience coordinating both investigator-initiated and industry-sponsored FDA-regulated clinical trials, including start-up, monitoring, and closeout activities.
Experience with Electronic Medical Records (EMR).
Experience with electronic data capture systems (EDCs) and query resolution
Experience or certification in phlebotomy, EKG, vitals, and biological specimen processing, or willing to obtain certification.
Experience with IRB submissions, including initial applications, continuing reviews, amendments and closeouts.
Experience administering common psychiatric research assessments such as the SCID, MINI, MADRS, HAM-D, and CSSRS.
Experience with institutional systems such as REDCap, InfoEd, CU Marketplace, and Clinical Trial Management Systems (CTMS) such as OnCore.

Responsibilities

Assist with the day-to-day operations of clinical trials.
Recruit, screen, and track patients for clinical trials, maintain relevant subject logs, and maintain correspondence with research participants including trouble shooting study-related issues.
Schedule and execute study visits and perform study procedures such as obtaining informed consent, administering surveys and other study assessments including mental health assessments, performing clinical procedures such as ECG, phlebotomy, vital signs and fMRI scans, and managing participant reimbursement.
Collect and process biological samples.
Review and synthesize study protocols, case report forms and other study specific documents.
Perform data entry into various electronic data capture systems and assist with study data quality checking and query resolution.
Participate in department and supervisory meetings, as well as attend PI/lab meetings for specific projects as needed.
Assist with various regulatory processes and related document maintenance.