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University of Colorado · 5 hours ago

Clinical Research Coordinator (Breast Team)

Aurora, CO

Full-time

Hybrid

Entry, Mid, Senior Level

$48K/yr - $57K/yr

1+ years exp

The University of Colorado Anschutz Medical Campus is a leading institution in cancer research and patient care. They are seeking a Clinical Research Coordinator for the Breast Team to manage clinical trials, ensuring compliance with research protocols and regulatory standards while collaborating with various stakeholders to facilitate research activities.

EducationHigher EducationUniversities

No H1B

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

Qualification

Clinical research experienceElectronic data capture systemsClinical Practice (GCP)Certified Clinical Research CoordinatorCustomer service skillsAnatomyCommunication skills

Required

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

Preferred

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