Employment Type:

Permanent Staff (EHRA NF)

Vacancy ID:

NF0010018

Salary Range:

Salary commensurate with qualifications

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 Operations 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 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 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; 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.

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.