Phase 1 Data Coordinator
University of Colorado Denver l Anschutz Medical Campus
The University of Colorado Cancer Center
Data Coordinator (Phase 1)
Position # 00745006 - Requisition 13885
* 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 Data 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 a key member of the clinical research team, the Data 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, collecting data from a variety of sources and recording them into databases for review; simultaneously, addressing and amending ongoing queries from previously reported data. The incumbent collaborates with team members in obtaining toxicity grading, including assessment of clinical significance of all lab and test results and relatedness of adverse reactions according to protocol guidelines. It is critical to be detail oriented to ensure accuracy and integrity of the data.
The person in this position also schedules, coordinates, and prepares for monitoring visits and audits as well as communicates appropriately and effectively with study subjects, investigators, and other team members. Finally, the position performs clinical duties as assigned based on appropriate licensure and/or completion of competency documentation and team needs. The successful incumbent has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.
Examples of Work Performed
- 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
- Collaborates with Clinical Research Staff in obtaining toxicity grading levels, including assessment of clinical significance of all lab and test results and relatedness of adverse reactions according to protocol guidelines
- Schedules, coordinates, and prepares for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs, Primary CRC and other research team members
- 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
- Conducts follow-up of study patients
- Performs clinical duties as assigned based on appropriate licensure and/or completion of competency documentation
- Independently coordinates and manages data entry, queries, and monitor visits
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 $40,000 and is negotiable and commensurate with skills and experience. This position is 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.
- Associate's Degree or higher in any field or two years' experience in a medical or clinical environment
- Knowledge of and experience with basic human anatomy, physiology, and medical terminology
- Experience using Microsoft Office products
- Research experience, oncology is a plus
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
- This position requires the ability to sit for long periods of time
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 firstname.lastname@example.org 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 Heather McCoy at Heather.McCoy@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 22, 2018. Those who do not apply by June 22, 2018 may or may not be considered.
Job Category: Professional Support Services
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20066 - SOM-U of Colo Cancer Center
Posting Date: Jun 12, 2018
Closing Date: Ongoing
Posting Contact Name: Heather McCoy
Posting Contact Email: Heather.McCoy@ucdenver.edu
Position Number: 00745006