Clinical Research Coordinator- Breast Team (Level I, II, or III – Open Rank)
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
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- Administrative Jobs
- Academic Affairs, Research Staff & Technicians, Institutional & Business Affairs, Athletics
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
University of Colorado Anschutz Medical CampusSchool of Medicine, Cancer CenterCancer Clinical Trials Office (CCTO)Research Services Professional (Entry, Intermediate, or Senior – Open Rank)Clinical Research Coordinator (Level I, II, or III – Open Rank)Breast TeamPosition #00704213 Requisition #22586* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2Denver: https://www.ucdenver.edu/coronavirusExemptions vary by campus location/department. Campus/Unit-Specific Exemptions:
Qualifications
Minimum Qualifications:Clinical Research Coordinator – CRC I Level
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Aug 26, 2021
Unposting Date: Ongoing
University of Colorado Anschutz Medical CampusSchool of Medicine, Cancer CenterCancer Clinical Trials Office (CCTO)Research Services Professional (Entry, Intermediate, or Senior – Open Rank)Clinical Research Coordinator (Level I, II, or III – Open Rank)Breast TeamPosition #00704213 Requisition #22586* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2Denver: https://www.ucdenver.edu/coronavirusExemptions vary by campus location/department. Campus/Unit-Specific Exemptions:
- Anschutz Campus – Exemptions are allowed for medical or religious reasons.
- Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.
- Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.
- Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial. Performs 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
- Interviews prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
- Schedules subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
- Familiar with protocol and all study documents and reviews documents after each study subject visit for completeness and accuracy
- Abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into the Cancer Center clinical trials database in an accurate and timely fashion
- Ensures complete source documentation is compiled for each study subject record
- Provides review of patient eligibility determination by:
- Gathering source documentation
- Ensuring the most current and approved version(s) of the study informed consent forms are completed and that the informed consent process is properly documented and consent form filed
- Reviewing study subject Medical History to determine eligibility status
- Obtains oncology grading levels for study product toxicities, including assessment of clinical significance of all lab and test results and relatedness of adverse reactions to study product according to protocol guidelines
- Schedules and tracks submission of Prescreening, Screening and Enrollment Logs, as required by Sponsor
- Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)
- Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
- Works on multiple research studies simultaneously
- Serves as a liaison with Sponsors and with study subjects for ongoing clinical research studies
- Independently coordinates and manages data entry, queries, and monitor visits
- Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
- Collaborates with 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)
- May be trained to perform the following on study subjects:
- Electrocardiograms
- Measurement of blood pressure, pulse, height, weight, and temperature
- Phlebotomy (direct venipuncture)
- Assists Team Supervisors with creation and conduct of process and quality improvement projectsPrimary Coordinator on multiple trials, educates potential subjects on the details of the study, coordinator/scheduling study assessments required by the study protocolMaintains compliance with all training requirements, meets established deadlines for data submission, possesses an understanding of clinical research history, regulations, and ethics
- Performs additional duties as assigned by supervisor or manager.
- Assists Team Supervisor with creation of training process documents and toolsTrains, assesses, and mentors new Clinical Research Coordinators, as directed by Supervisor/ManagerPerforms additional duties as assigned by team supervisor and managerAssists with study start-up tasksServes as role model to all Clinical Research Coordinators – remains in compliance with all training requirements, meets established deadlines for data submission, possesses a strong understanding of clinical research history, regulations, and ethics
Qualifications
Minimum Qualifications:Clinical Research Coordinator – CRC I Level
- Bachelor’s degree in any field.
- Bachelor’s degree in any field.One (1) year of clinical research experience and one (1) year of clinical and/or research experience.
- Bachelor’s degree in any field.Two (2) years of clinical research experience and one (1) year of clinical and/or research experience.
- CCRC – Certified Clinical Research Coordinator
- CCRP – Certified Clinical Research Professional CCRA – Certified Clinical Research Associate
- Oncology Clinical Research experience (any clinical research experience for CRC I level)Experience with electronic data capture systemsBachelor’s degree in science or health related field
- Knowledge of basic human anatomy, physiology medical terminology. Analytical Skills - Ability to interpret and master complex research protocol information.Attention to Detail – Work is accurate, and details are not overlooked.
- Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
- Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
- Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
- Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
- Adaptability – Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
- Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
- Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Aug 26, 2021
Unposting Date: Ongoing
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