Clinical Research Professional, UC Cancer Center, Office Based Coordinator
University of Cincinnati
- Cincinnati, OH
- Permanent
- Full-time
- Complete training and follow established CTO workflows and CTO/UC Health standard operating procedures.
- Proactively review and locate source documentation for all study procedures, including, but not limited to, lab work, CT scans, MRIs, ECHOs, eye exams, physical exams, oral, IV, or intratumoral drug administrations, pulmonary function tests, cardiac stress tests, biopsies.
- Accurately enters data from source documentation listed above, outside hospital records, and/or hard-copy research-specific documents, into study specific electronic data capture (EDC) systems for clinical research trials within 5 days of the patient visit EDCs include, but are not limited to, RedCap, Inform, Medidata Rave, Viva Vault, and Trial Master.
- Proactively seeks to promptly resolve outstanding data queries and any issues relating to missing or incomplete source documentation through collaboration with clinical research coordinators (CRCs).
- Reviews all data entered EDCs and subject charts to identify and help resolve any general quality issues with CRCs and quality assurance (QA) staff as needed. (i.e., data collected per protocol and meets GCP, ALCOA standards etc...).
- Conducts study participant follow-up as required per protocol.
- Communicates and collaborates within assigned research team and with principal investigators in a professional, helpful, and service-oriented manner to effectively accomplish job duties.
- Acts as the primary point of contact for monitoring visits – ensuring monitors have access to records, facilities, and remaining available for questions for the duration of a visit.
- Assists the PRMC/DSMB Coordinator or other QA staff with projects as needed.
- Able to independently maintain and meet form & database development milestones effectively.
- Maintain/Update patients’ status and visit completions in the Clinical Trial Management System.
- Along with team, maintain Team’s biospecimen collection kit inventory, re-ordering supplies.
- Create and maintain positive working relationships with multidisciplinary teams.
- Perform related duties based on departmental/team needs.
- Bachelor’s Degree must be in a related field.
- Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
- Prior experience in clinical research coordination or clinical research data management, and SignalPath, Complion, RedCap, Inform, Medidata RAVE, etc. systems is ideal.
- Highly comfortable with computer-based and online systems.
- Must be able to interact and communicate with clinical research staff, PIs, and industry sponsors in a professional manner.
- High attention to detail and organizational ability and ability to prioritize tasks.
- Can accomplish work independently.
- Capable of advising and explaining information to others.
- Ability to manage moderately complex projects.
- Working knowledge of, and ability to apply, Good Documentation Practices, ALCOA, and ICH-GCP to data management and database design.
- Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence.
- Office environment/no specific unusual physical or environmental demands.
- Competitive salary range dependent on the candidate's experience.
- Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
- Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
- Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
- Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
- Tuition remission is available for employees and their eligible dependents.
- Enjoy discounts for on and off-campus activities and services.