Clinical Research Coordinator 1-2;… at University of… · Charlotte…

Summary: The University of Virginia's Department of Pediatrics is seeking candidates for a Clinical Research Coordinator (CRC) position at experience levels CRC 1 and CRC 2. The CRC will support clinical research efforts, manage study documentation, ensure regulatory compliance, and collaborate with healthcare professionals on various clinical trials. Responsibilities: - Work closely with Principal Investigators and other study team members on all clinical research projects assigned - Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets - Assist in preparation, maintenance or creation of study documents such as: study visit schedules, study drug diaries, monitoring or training logs, equipment records or study communications - Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment - Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments - Notify PI and/or supervisor of any potential issues with the study or subject status - Communicate effectively with study Sponsor(s) - Liaise with other groups outside of the Department of Pediatrics to support clinical research activities that will enable us to run trials in an effective manner - Collect subject data, maintain appropriate logs, track participants and prepare study materials - Perform data entry into internal and external electronic databases - Collect process, prepare, store and ship laboratory specimens as necessary - Prepare and submit necessary documents for Institutional Review Boards (IRB), FDA, National Institutes of Health (NIH) or Data Safety Monitoring Board (DSMB) review; document and report protocol deviations - Able to work with minimal supervision - Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies - Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature - Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting, and compliance oversight - Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third-party payer - Orient and/or provide basic training to new study team members - Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as IRB Pro, Protocol Builder, OnCore, iMedidata, Inform, Openclinica, Epic, and other data management platforms - Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning - In addition to the above job responsibilities, other duties may be assigned Required Qualifications: - Bachelor's Degree Required or equivalent combination of experience, education and or certifications - Some experience in a healthcare setting and/or knowledge of medical terminology is preferred - At least one year of clinical research experience for CRC2 - Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies - Able to work with minimal supervision - Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as IRB Pro, Protocol Builder, OnCore, iMedidata, Inform, Openclinica, Epic, and other data management platforms - Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning - Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment Preferred Qualifications: - Some experience in a healthcare setting and/or knowledge of medical terminology Required Skills: Clinical trial coordination, Regulatory compliance, Data management, Informed consent process, Patient recruitment, Adverse event reporting, Electronic data entry, Institutional Review Board submission, FDA regulations, Study documentation, Clinical research administration, Medical terminology, OnCore, iMedidata, OpenClinica, Epic Benefits: Learn more about UVA benefits, Background checks, pre-employment health screenings, and drug screening will be conducted on all new hires prior to employment.