"Lead Study Coordinator"

Position Summary/Description:

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.

Education 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.
• Three years of clinical trial coordination experience, two of which must be in oncology.
• SOCRA/ACRP Certification.

Essential Skills:

• Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols.
• Advanced knowledge of clinical research coordination.
• Possess strong decision-making skills and the ability to problem solve and troubleshoot issues.
• High level of accuracy and attention to detail.
• Strong computer skills.
• Ability to gather data and document procedures.
• Ability to plan work and coordinate multiple projects.
• Ability to contribute to preparation and delivery of reports, trainings and SOPs.
• Customer oriented and ability to work in a team environment.
• Ability to communicate effectively and professionally verbally and in writing.
• Ability to work on evenings, weekends and/or holidays occasionally required.

AA/EEO Statement:

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.