Clinical Research Coordinator (Open Rank) – GU Team

University of Colorado•Aurora, CO

1d•Hybrid

About The Position

Clinical Science Professionals at all levels perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. This description is a summary only and describes 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. The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to “unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education.” Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

Requirements

Bachelor’s degree in any field
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
One (1) year of professional clinical research experience and/or professional clinical experience post Bachelor’s degree
Applicants must meet minimum qualifications at the time of application.
Please be advised that Clinical Research Coordinators (CRC) are not eligible now or in the future for visa sponsorship.

Nice To Haves

Bachelor’s degree in science or health related field
Three (3) years of clinical research or related experience
Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
Additional certification (one of the following):
CCRC – Certified Clinical Research Coordinator
CCRP – Certified Clinical Research Professional
CCRA – Certified Clinical Research Associate
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
Outstanding customer service skills
Knowledge of basic human anatomy, physiology medical terminology
Ability to interpret and master complex research protocol information

Responsibilities

Assist with and oversee the day-to-day operations of clinical trials and studies
Independently abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into clinical trials database in an accurate and timely fashion
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 and 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)
Collaborate with other clinical research team members, investigators, and 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); follow up with appropriate persons on missing or discrepant data
Meet with Monitors to respond to any question of data validity and correct/revise data as appropriate; respond to queries from Sponsor
Adhere to research regulatory standards
Maintain detailed records of studies including Patient Source Document Binder to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Assist with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Schedule, coordinate, and prepare for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs, Primary CRC and other research team members
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
Act as a Primary Coordinator on multiple trials/studies
Assist and train junior team members
Assist with developing or develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
Assist with identifying issues related to operational efficiency and shares results with leadership
Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
Serve as a resource and participate in study initiation and close out duties