Clinical Research Associate

Clinical Research Associate

Your passion belongs at UNC Health. Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North Carolina.

Summary: Collaborates with the Clinical Research Nurse/Clinical Research Specialist, Clinical Research Associate and Principal Investigators in the execution of oncology clinical research.

Responsibilities: 1. Maintains an environment of safety for patients, self and others. 2. Recruit, screen, and enroll study subjects in research studies under supervision of clinical research nurse. 3. Obtain written informed consent with appropriate HIPAA authorization from each patient prior to study enrollment under supervision of clinical research nurse. 4. Collect and enter data on case report forms and verify accuracy and completeness. Complete data query resolution. 5. Follow SOPs (standard operating procedures) for initial submission of clinical trial to IRB and for continuing review. Ensure IRB approval prior to study initiation. Submit protocol amendments, informed consent revision to IRB for approval prior to implementation of any clinical trial changes. 6. Maintain accountability for investigational product to include ordering, maintenance of records, proper storage. 7. Participate in sponsor audits and/or regulatory inspections of records and documents. 8. Participate in site-initiations and start-up meetings. 9. Assist with financial management of studies to include accurate registration, processing invoices, and maintain payment files.

Education Requirements: Bachelor's degree required, preferably in a health related field. Licensure/Certification Requirements: Professional Experience Requirements: Clinical research experience preferred. Knowledge/Skills/and Abilities Requirements: LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Statistical Reporting; Analyzing Trends; Statistical Analysis; Data Verification; Data Coding-General; Data Analysis/Interpretation. REASONING ABILITY Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.