Lead Study Coordinator

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. Reporting to the Clinical Research Manager, the Lead Study Coordinator independently manages multiple complex trials through the protocol life cycles of activation, implementation and closure. As Lead Study Coordinator, provide team lead and programmatic support on a daily basis, lead patient care and advising activities and serve as preceptor for new hire; providing ongoing training and first line support for staff. 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.

Minimum Education and Experience Requirements

Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols; Advanced knowledge of clinical research coordination; Strong computer skills; Ability to contribute to preparation and delivery of reports, trainings, and SOPs; Customer-oriented and team-oriented; Ability to communicate effectively and professionally, both verbally and in writing; Ability to work on evenings, weekends and/or holidays occasionally required.

Preferred Qualifications, Competencies, and Experience

Previous experience with clinical research involving tissue, questionnaires, and/or devices; Experience navigating medical records and data extraction; Experience with sharing data and specimens amongst multiple institutions; Three years of clinical trial coordination experience, two of which must be in oncology; SOCRA/ACRP Certification