University of Colorado – School of Medicine
Clinical Research Coordinator (PRA)
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
The University of Colorado’s Division of Gastroenterology and Hepatology in the Department of Medicine, located at the Anschutz Medical Campus, is an internationally renowned program that provides comprehensive resources for the diagnosis and therapy of diseases of the digestive tract, pancreas and liver. The Division of Gastroenterology and Hepatology has faculty and staff making contributions to research, clinical trials, and nationally recognized patient care. Gastroenterology & GI Surgery is one of the top ranked in the United States and our clinical partner, the University of Colorado Hospital, and is in the top hospitals nationwide as ranked by U.S. News and World Report. The Division of Gastroenterology and Hepatology is rapidly growing, with clinical practices throughout the state of Colorado and over 80 researchers, physicians and staff, all working toward its vision to prevent and treat disease while being a global model for patient care delivery, interdisciplinary research, and training.
_Nature of Work_
As an important member of the colorectal cancer prevention research team, the Clinical Research Coordinator works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position will be part of a collaborative research program with the University of Colorado and the Denver Veteran’s Affairs Hospital focusing on how colorectal polyps affect cancer risk and studying strategies to decrease risk. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits. The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all. This position may require occasional travel throughout the Denver Metro area.
_Examples of Work Performed_
Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial. Performs 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. Specific duties also include:
Interviews prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews.
Collects data/responses from research subjects over the phone through administration of phone-based surveys.
Schedules subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Familiar with protocol and all study documents and reviews documents after each study subject visit for completeness and accuracy
Abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into the clinical trials database in an accurate and timely fashion
Ensures complete source documentation is compiled for each study subject record
Provides review of patient eligibility determination by:
o Gathering source documentation
o Ensuring the most current and approved version(s) of the study informed consent forms are completed and that the informed consent process is properly documented and consent form filed
o Reviewing study subject Medical History to determine eligibility status
Assesses for clinical significance of all lab and test results and relatedness of adverse reactions to study product according to protocol guidelines
Schedules and tracks submission of Prescreening, Screening and Enrollment Logs, as required by Sponsor
Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)
Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
Works on multiple research studies simultaneously
Serves as a liaison with Sponsors and with study subjects for ongoing clinical research studies
Independently coordinates and manages data entry, queries, and monitor visits
Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
Collaborates with hospital staff to ensure tests and procedures, required by research protocols, are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures)
May be trained to perform the following on study subjects:
o Measurement of blood pressure, pulse, height, weight, and temperature
o Phlebotomy (direct venipuncture)
o Research specimen collection, processing and shipping
/This description is a summary only and is describing the general level of work being performed; it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority./
2 years’ Clinical Research experience
Gastroenterology and/or Hepatology Clinical Research experience
Ability to speak, read, and write in both English and Spanish on a daily basis. The successful candidate will be fluent in both languages.
Experience working with RedCap
Experience working with an electronic medical record; experience with EPIC and CPRS is strongly preferred.
Experience with database software (such as MS Access)
Experience with statistical software
Experience working with patients in a clinical setting
_Knowledge, Skills and Abilities_
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 and patient relations skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Excellent organizational skills, ability to problem-solve, multi-task, and work independently.
Excellent attention to detail.
Ability to interpret and comprehend complex research protocol information.
Excellent computer skills including proficiency in Microsoft Office products.
Knowledge of basic human anatomy, physiology, medical terminology.
Organization: *H0001 -- Anschutz Medical Campus
Title: Clinical Research Coordinator (PRA)
Requisition ID: 15503