Clinical Research Coordinator (Breast Team)

University of Colorado•Aurora, CO

6d•$48,446 - $56,995•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. Key Responsibilities: Entry Level or CRC I: Level of clinical or data focused tasks will be determined at the discretion of the supervisor/manager based on team needs. 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 Intermediate Level or CRC II, all the above and: 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 Senior Level or CRC III, all the above and: 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 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.

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
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