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University of North Carolina- Chapel Hill Soc/Clin Research Specialist in United States

Employment Type: Permanent Staff (SHRA)

Vacancy ID: P011078

Salary Range: $50,145 - $60,000

Position Summary/Description:

This position will serve as a Clinical Research Specialist for a multidisciplinary research department, under the direction of the UNC McAllister Heart Institute. This position will coordinate research projects in the Hemostasis and Thrombosis Department, including multiple clinical trials and other related endeavors. This position will coordinate ongoing and future clinical trials to support the research efforts of the department. This position will manage all information and requests related to project responsibilities, and collaborate with clinical trial steak holders within and outside of UNC Health Care. The range of duties includes, but is not limited to: clinical trial coordination, study start-up, IRB applications, database development and management, data/information collection and analysis, collaboration with industry and federal sponsors, laboratory sample preparation, processing, and shipping, and preparing status reports for clinical trial PIs and HTC research supervisor.

Position responsible for updating the list of current and planned studies; planning personnel needs based on current and expected workload, working on developing common quality standard and SOPs for the team. The position will review study budgets to ensure they are adequate to cover the expenses from each study prior to budget submission to sponsor.

Education and Experience:

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.

Essential Skills:

Attention to detail and the ability to produce accurate results are critical. Work may include the training and supervision of staff, students, and others. Candidate must be willing to support a flexible schedule to meet department and study needs; occasional travel, and/or weekend work may be required.

Candidate must have clinical experience with direct patient care or medical patient chart review and understanding of clinical laboratory data review.

This position requires past experience with regulatory document development and submission, protocol and clinical study document development and review.

Preferred :

Ideal candidate will have extensive experience with clinical trial coordination from inception through close out. Experience in multiple therapeutic areas desirable.

Ability to trouble-shoot and resolve quality control issues by changing processes. Attention to detail and the ability to produce accurate results are critical.

Clinical research coordinator certification (CCRP, ACRP, etc.) and previous experience with UNC systems and preference for candidates with previous experience with research related databases (e.g., Oracle Clinical RDC, Inform, Medidata, RedCap, etc.).

Proficiency in sample processing and shipping.

AA/EEO Statement:

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.