Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Colorado Springs

Description

DescriptionUniversity of Colorado | CU Anschutz Medical CampusSchool of Medicine, Cancer CenterResearch Services Professional (Open Rank)Clinical Research Coordinator (GU/Renal) (Open Rank)Position #736909– Requisition #17871
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
The Cancer Center has an opening for a full-time University Staff (unclassified) Research Services Professional (Clinical Research Coordinator (GU/Renal)) position.
The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.
The University of Colorado Cancer Center, headquartered at the Anschutz Medical Campus, is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.
The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center is a consortium of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.
The Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center is seeking to employ a full time Clinical Research Coordinator (CRC). Depending on qualifications and department needs, appointments may be made at the CRC I, CRC II, or CRC III level.
Nature of WorkAs an important member of the research team, the Clinical Research Coordinator works with Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits. The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.
Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.
Professionals in this career family are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field.
At the entry level, duties are limited in scope and are performed with guidance and direction from other professionals and are performed in a training and development capacity.
At the intermediate level, duties may be more limited in scope and are performed with guidance and direction from other professionals.
At the senior level, work is performed fully independently.

Examples of Work Performed by the Clinical Research Coordinator (all levels):
- 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:

o Gathering source documentation o 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 o 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:

o Electrocardiograms o Measurement of blood pressure, pulse, height, weight, and temperature o Phlebotomy (direct venipuncture)
- Research specimen collection, processing and shipping, develops protocol-specific source documents (e.g., data collection tools, study visit checklists, pharmacokinetic sample collection worksheets, etc.)
- Assists Team Manager and/or Financial Team by processing bills and/or answering billing questions related to procedure performed for subjects enrolled in clinical trials
- Serves as Primary Coordinator for clinical trials

Examples of Work Performed by Clinical Research Coordinator (Level II):
- Assists Team Supervisors with creation and conduct of process and quality improvement projects
- Trains, assesses, and mentors new Clinical Research Coordinators, as directed by Supervisor/Manager
- Serves 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

Examples of Work Performed by Clinical Research Coordinator (Level III):
- Assists Team Supervisor with creation of training process documents and tools
- Trains, assesses, and mentors new Clinical Research Coordinators, as directed by Supervisor/Manager
- Performs additional duties as assigned by team supervisor and manager
- Assists with study start-up tasks
- Serves as role model to all Clinical Research Coordinators – remains in compliance with all training requirements, meets established deadlines for data submis

  • billing
  • education
  • nurse
  • performed
  • protocol