Clinical Research Coordinator (GU/Renal)
University of Colorado Denver l Anschutz Medical Campus
University of Colorado Cancer Center
Clinical Research Coordinator (GU/Renal)
Position # 00699517 - Requisition 13859
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The University of Colorado Cancer Center has an opening for a full-time University Staff (unclassified) Clinical Research Coordinator position.
The University of Colorado Cancer Center, located 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 partner for adult care, University of Colorado Hospital is ranked in the top 15 hospitals nationwide by U.S. News and World Report and Children's Hospital Colorado is ranked 8th by the same organization in Pediatric Cancer Care. 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 261 researchers and physicians at three state universities and three clinical institutions, all working toward its vision to prevent and cure cancer while being a global model for patient care delivery, interdisciplinary research, and training.
Nature of Work
As 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.
Examples of Work Performed
- 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:
- Measurement of blood pressure, pulse, height, weight, and temperature
- Phlebotomy (direct venipuncture)
- Research specimen collection, processing and shipping
This description is a summary only and is describing 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.
Salary and Benefits
The hiring salary for this position is $41,411 and is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services.
- Bachelor's degree in any field
- Substitution: Any equivalent combination of Education or Experience (e.g., Associate's Degree plus 2 years of clinical and/or research experience) or 4 years' relevant work experience
- Clinical Research experience (Oncology Clinical Research experience a plus)
- Experience with electronic data capture systems
- Bachelor's degree in science or health related field
Knowledge, Skills and Abilities
- Excellent interpersonal communication skills, organizational skills, and ability to problem-solve, multi-task, and work independently
- Good command of the English language, both written and verbal
- Excellent attention to detail and ability to interpret and master complex research protocol information
- Excellent computer skills including proficiency in Microsoft Office products
- Knowledge of basic human anatomy, physiology, medical terminology
Diversity and Equity
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Office of Equity by email at email@example.com or by phone at (303) 315-2567.
The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers * REQUIRED APPLICATION MATERIALS: 1). A cover letter/letter of application which specifically addresses the job requirements and outlines qualifications. 2) A current resume/CV. 3) List of 3-5 professional references. Questions should be directed to Michael Wacker at Michael.Wacker@ucdenver.edu.
Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. We will notify you prior to contacting both on and off-list references.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:APPLICATION DEADLINE: Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by June 17, 2018. Those who do not apply by June 17, 2018 may or may not be considered.
Job Category: Research Services
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20066 - SOM-U of Colo Cancer Center
Posting Date: Jun 7, 2018
Closing Date: Ongoing
Posting Contact Name: Michael Wacker
Posting Contact Email: Michael.Wacker@ucdenver.edu
Position Number: 00699517