Open Rank Clinical Research Coordinator (Entry – Senior)

University of Colorado•Aurora, CO

19d•Onsite

About The Position

This is a 100% FTE position for a Clinical Research Coordinator in the Pulmonary Vascular Disease Center Program (PVDC) as a component of the Center for Lungs and Breathing (CLB) at University of Colorado Hospital. This full-time position will assist in conducting clinical trials and research projects for the PVDC Program .

Requirements

Entry Level: Bachelor’s degree in any field. A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Intermediate Level: Bachelor’s degree in any field. A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis. One (1) year clinical research or related experience.
Senior Level: Bachelor’s degree in any field. A combination of education and related technical/military/paraprofessional experience may be substituted for a 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.
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 as well as sponsors.
Ability to interpret and master complex research protocol information.
Requires independent judgment as well as self-directed work capabilities.
Ability to establish work priorities, multitask, and handle multiple deadlines.
Ability to handle sensitive and confidential information and documents and maintain strict confidentiality in all HIPAA matters.
Ability to work independently as well as part of a team.
Ability to use various computer systems and software applications.
Strong organizational skills and attention to detail.
A high level of proficiency with computers and use of Microsoft Access, Excel, Outlook, Word, and other University and Departmental systems as required.
Advanced computer skills, particularly with PeopleSoft, COGNOS Microsoft Access, Excel, Outlook, Word, and other University and Departmental systems as required.
Knowledge and experience with IRB policies and procedures.

Nice To Haves

Bachelor’s degree in science or health related field.
Two (2) or more years’ experience with coordinating and managing administrative and clinical research activities.
Experience with creating and maintaining clinical research projects and clinical trials.

Responsibilities

Collaborating with principal investigators and co-investigators to enroll clinical trial patients.
Conducting study visits.
Overall compliance with the policy and procedures for conducting good clinical trials.
Screening, consenting and enrolling study participants.
Collecting, processing, and storing samples for research.
Medication compliance tracking and coordinating protocol procedures.
Collect and report all patient reported adverse drug reactions and other serious adverse events.
Patient education and follow-up per protocol guidelines.
Routine meetings with monitors to reconcile data management issues.
Participation in investigator’s meetings.
Preparing and submitting compliance documentation for the institutional review board.
Submission to the Human Research Subjects Portal for UCH-RSS review and approval.
Maintenance of databases.
Abstracting data from patient charts and electronic medical records.
Service in the following areas: Clinical Research Advisory Forum (RAF). Clinical Research Coordinators Committee (CRC).