Clinical Research Coordinator (RT Team)

University of Colorado

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. The role is offered at Entry Level (CRC I), Intermediate Level (CRC II), and Senior Level (CRC III), with increasing responsibilities at each level. The University of Colorado Cancer Center is the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, dedicated to preventing and conquering cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education.

Requirements

Applicants must be legally authorized to work in the United States without requiring sponsorship
Bachelor’s degree in any field OR a combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis (for CRC I, II, and III)
One (1) year of professional clinical research experience and/or professional clinical experience post Bachelor’s degree (for CRC II)
One (1) year of professional clinical research experience and one (1) year of professional clinical research experience and/or professional clinical experience post Bachelor’s degree (for CRC III)
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

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

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 corrects/revises data as appropriate; responds 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
Assists 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
Schedules, coordinates, and prepares 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