Clinical Research Coordinator

University of Colorado

57d•Hybrid

About The Position

The Clinical Research Coordinator (CRC) will work within the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology. The role will be to coordinate the daily activities required to conduct clinical research protocols, recruitment and enrollment of research participants, schedule study participant clinic visits, accurately record and enter data, process biospecimens, respond to data queries from study sponsors, and support physician investigators. The position may be utilized to support research at the main Anschutz Medical Campus. The CRC in this position will not be called on to make independent medical decisions at any time, but a solid fundamental knowledge of biological and medical sciences is necessary for this position. Additionally, appreciation of accepted methods of clinical research is highly desirable.

Requirements

Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
One year experience working in clinical research
Experience working in a healthcare setting
Applicants must meet minimum qualifications at the time of hire.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Knowledge of basic human anatomy, physiology, medical terminology
Advanced knowledge of GCP, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions
Proficient with Clinical Research Coordinator duties/responsibilities
Organization and time management skills
Leadership abilities
Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with National Cancer Institute (NCI) sponsored, private industry and investigator initiated clinical trials

Nice To Haves

Proficient with Microsoft Office including Outlook, Excel, Word and PowerPoint.
Spanish fluency
One year of oncology research
Experience serving as a primary coordinator for clinical trials
CCRC – Certified Clinical Research Coordinator
CCRP – Certified Clinical Research Professional
CCRA – Certified Clinical Research Associate

Responsibilities

Study Subject Recruitment, Screening & Enrollment
Obtaining study subject medical history and current medication information
Reviewing research protocol Inclusion/Exclusion Criteria
Confirming subject eligibility to participate in clinical trials
Interviewing and educating prospective subjects via phone and in person
Performing or ensuring the informed consent process has occurred, is properly documented, and consent forms are filed appropriately
Gathering source documentation to support eligibility determination
Scheduling and tracking prescreening, screening, and enrollment logs as required by Sponsor
Study Coordination & Clinical Operations
Scheduling subject participation in research clinical trials
Coordinating availability of study space and clinical research support (physicians, nurse practitioners, laboratory, radiology, pharmacy)
Collaborating with hospital staff to ensure protocol-required tests and procedures are performed and documented
Serving as Primary Coordinator for clinical trials
Working on multiple research studies simultaneously
Serving as a liaison with Sponsors and study subjects for ongoing clinical research studies
Data Management & Documentation
Abstracting and recording research subject data onto protocol-specific Case Report Forms (CRFs) and into clinical trial databases
Ensuring complete and accurate source documentation for each study subject record
Reviewing study documents after each subject visit for completeness and accuracy
Ensuring capture of all protocol-required data points
Independently coordinating and managing data entry, data queries, and monitor visits
Meeting with Monitors to respond to questions of data validity and correcting/revising data as appropriate
Regulatory Compliance, Safety & Monitoring
Obtaining oncology grading levels for study product toxicities
Assessing clinical significance of laboratory and test results and relatedness of adverse reactions per protocol
Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (PI, Sponsor, FDA, DSMC, Regulatory Affairs)
Assuring compliance with all protocol requirements and regulatory standards
Assisting with Sponsor, Data Safety Monitoring, and FDA audits and responses
Assisting with regulatory submissions
Ensuring the most current and approved informed consent documents are used and properly filed
Administrative, Financial & Professional Development
Assisting Team Manager and/or Financial Team with billing processing and billing-related questions
Maintenance of study-specific certifications, COMIRB training, computer training, and other hospital-required training