Denver Research Institute Department of Endocrinology, Metabolism, and Diabetes has an opening for a full-time Clinical Research Coordinator I, Dr. Rasouli Research Group. The candidate will be working both at the Anschutz Medical campus and Denver VA Medical Center. This position will support various multi-site projects under the direction of Dr. Neda Rasouli.
Examples of Work Performed:Under the supervision of the Clinical Research Manager/ PI, the primary responsibility of the Professional Research Assistant is to serve as the clinical research coordinator in support of various research activities within Dr. Neda Rasouli’s Research Program.
• This is a position requiring interest in medical research, the ability to be self-directed, detail-oriented, and adaptable in a high-intensity research environment involving multiple NIH and industry sponsored pharmaceutical research studies.• May be asked to assist in the preparation of initial and ongoing regulatory submissions to the IRB and the VA Research and Development system under guidance of the regulatory or research manager• May be asked to assist with payment processing of internal or external invoices• Implement study recruitment and enrollment procedures• Implement current mechanisms identifying potential patients• Maintain subject tracking database.• Educate patients and staff about the study.• Participate in study meetings and trainings as required.• Complete research documentation, utilizing medical records, lab guidelines, protocol information and other resources to accurately pre-screen potential participants• Coordinate with the research and clinical teams to schedule subjects for research visits.• Track patient participation• Attend health fairs and network with applicable organizations relating to the disease/disorder being studied.• Attend study related meetings and conferences as required.
Other duties as assigned:• Maintains comprehensive knowledge of all protocols carried out by the collaborating physicians.• Assist in the day to day duties required for clinical trial operations including but not limited to, conducting initial recruitment and completes medical history for research study subjects, schedules study subjects’ clinic visits.• Reviews protocol inclusion/exclusion criteria, and confirms eligibility of subject with investigator. Ensures that the informed consent process has occurred, is properly documented and filed as required.• Interviews prospective subjects for multiple clinical studies. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews.• Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy• Abstracts and records all patient data essential to the study onto required Case Report Forms (CRFs) and into the Clinical Trials database, as needed, in an accurate and timely fashion. Maintains patient clinical research files.• Alerts the appropriate parties about serious adverse events; e.g. Principal Investigator, Study Sponsor, FDA, Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator.• Serves as a contact person for ongoing clinical research studies. Schedules monitoring visits and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of study records.• Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG’s, drug administration, and protocol specific tests and procedures.• May be called upon to perform the following specific tests and procedures: a) electrocardiogram, b) blood pressure, pulse, height, weight, and temperature measurements, c) phlebotomy (direct venipuncture) d) specimen processing and shipping
Required Education/Experience/Skills (Minimum Qualifications):• Bachelor's degree• Strong knowledge of medical terminology.• Highly organized, reliable, and able to work semi-autonomously; ability to multi-task and manage competing priorities; attention to detail.• Excellent computer skills, particularly with all software in Microsoft Office, including Word, Excel, Access, PowerPoint, and Outlook. Experience with the Internet and conducting Internet searches.• Up to date on required immunizations or willingness to obtain upon hire.• Recent documentation of negative TB test or willingness to obtain upon hire.
Desired qualifications:• Knowledge of the research process, e.g., research protocols, surveys• Strong clinical knowledge highly desired.• Ability to actively problem-solve, employing proactive, positive action steps.• Knowledge and understanding of HIPAA and Regulatory requirements for health care research.• Excellent written and oral communication skills• 1 year direct experience highly desired
Salary is commensurate upon experience.