Clinical Research Coordinator (Lung Team)

CU Denver; Aurora (CO); On-site; USD 52,000 - 76,000; Full time

Job summary

University of Colorado Anschutz Medical Campus is seeking a Clinical Research Coordinator to support the Lung Team in conducting patient-focused studies and coordinating diverse clinical trials.

You will manage data collection, eligibility reviews, and consent processes while collaborating with physicians, nurses, and regulatory staff to ensure protocol adherence and regulatory compliance.

Qualifications

• Experience in managing day-to-day operations of clinical trials.
• Ability to abstract and record data into CRFs and trials database.
• Experience obtaining study subject medical history and eligibility.
• Experience with informed consent processes and documentation.
• Ability to coordinate subject participation and scheduling with stakeholders.
• Familiarity with FDA regulations and regulatory guidelines.

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 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

Skills

Clinical research

Data abstraction

Informed consent

Patient recruitment

Regulatory compliance

Team collaboration

Study coordination

Tools

CRFs

Clinical trials database

EKG data collection

Audits

Job description

University Staff

University of Colorado Anschutz Medical Campus

Department: Cancer Center - CCTO (Lung Team)

Working Title: Clinical Research Coordinator (Lung Team)

Position #: 00680442 - Requisition #: 40360

Job Summary:

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