Position Summary
The purpose of this position is to facilitate the conduct of oncology clinical trials including subject and data management according to federal regulations Good Clinical Practice and local and institutional policies. These responsibilities relate to the mission of the UNC / LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact research quality and safeguard institutional integrity. 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.
Required Qualifications Competencies And Experience
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. Ability to work on evenings weekends and/or holidays occasionally required.
Preferred Qualifications Competencies And Experience
Previous experience with therapeutic clinical research involving drugs and/or devices. Experience in Phase I II and III clinical research. Experience navigating medical records and data extraction. SOCRA / ACRP Certification. Previous study coordinator experience to include exposure to oncology clinical trials or directly related oncology study coordinator experience.
Work Schedule
Monday Friday 8:30 AM 5:30PM
Required Experience:
Staff IC