Chapel Hill, NC19 days ago
The primary responsibilities of this position include the informed consent process, eligibility and screening, toxicity assessment, patient management, conducting in-services for nurses staff in treating clinic; planning of patient recruitment methods; logistics of patient visits; logistics of obtaining and coordinating clinical samples; specimen collection as needed, enlistment of support of necessary ancillary departments; coordinating the ordering of the required supplies; preparation of study tubes, collecting source documentation; Data entry / management for assigned studies, working with Clinical Research Associates to facilitate data collection for CRFs (case report forms) and/or eCRFs for trials as assigned; prepare and participate in monitoring visits; facilitate pre-site meetings, site initiation meetings, and plan, organize and run protocol start-up meetings. Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols; strong computer skills; ability to gather data and document procedures; ability to plan work and coordinate multiple projects; adequate social acumen and customer service skills; ability to communicate effectively and professionally verbally and in writing.