Permanent Staff (SHRA)

No

Soc/Clin Research Specialist - Journey

Research Specialist

20038800

P013047

$45,000 - $66,831

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

GN11

Full-Time Permanent

40

M-F, 8-5

Biostatistics - CSCC-462002

07/13/2021

07/30/2021

Chapel Hill, NC

Research Professionals

| The Collaborative Studies Coordinating Center (CSCC) is a division within the Department of Biostatistics of the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, NC (UNC). As the coordinating center for numerous multi-center clinical trials and epidemiology studies, the CSCC provides study design, data management, statistical analysis, quality assurance, and study management services to a broad array of projects funded primarily by the National Institutes of Health (NIH). The organization includes faculty from the departments of Biostatistics, Epidemiology, and Medicine and research staff with training and experience in biostatistics, epidemiology, medicine, computer science/data management, and project management. Total employees currently number between 100 and 105. The CSCC was established in 1971 as the Lipid Research Clinics (LRC) Coordinating Center and has operated continually since that time. To reflect the addition of new studies and expansion into new research areas, the LRC Coordinating Center changed its name to the Collaborative Studies Coordinating Center (CSCC) in 1984. Major research programs currently include the Atherosclerosis Risk in Communities Study (ARIC), Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), Back Pain Consortium (BACPAC) Research Program as part of the Helping to End Addiction Long-term Initiative (HEAL); Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS); Biological Underpinning of COPD Heterogeneity and Progression (SPIROMICS II); Women’s Health Initiative Extension (WHI) and WHISH-2 Prevent Heart Failure substudies of WHI; Precision Interventions for Severe and/or Exacerbation Prone Asthma Network (PrecISE); Hispanic Community Health Study (HCHS); and Preconceptional Health of Latinas and its Association with Child Adiposity (HCHS-FLOR). Information on these as well as others can be found at http://www.cscc.unc.edu/cscc/index.php

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.

Inclusive Excellence is a core value at the Gillings School of Global Public Health. We expect our faculty and staff to actively contribute to fostering an academic workplace climate that is welcoming and supportive for all.

The Social/Clinical Research Specialist works within a study team directed by a project manager and principal investigators (faculty). This position plays an important role in the Coordinating Center’s operational support for the needs of one or more studies, often managing specific projects within them. It requires the ability to both independently plan, organize, conduct, and evaluate public health research, working collaboratively within a team environment. The role may include document writing and the development of study reports in Spanish and English, designing and implementing training sessions for bilingual field center staff, providing project management support, developing systems to evaluate and manage research in a minority population, conducting monitoring visits and providing consultation in Spanish/English to field center staff, using problem solving skills to respond to study needs and coordinating and supporting the work of study committees. The level and responsibility of this position can vary from assisting in or managing projects to overseeing and directing others such as student assistants within project teams. The position may also be responsible for clinical research activities on an FDA-regulated study including the coordination and monitoring of clinical study conduct and data quality.

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.

This position requires a basic understanding of scientific principles, methods, results presentation and reporting. Knowledge of applied aspects of observational and clinical study design, data analysis, research data management and reporting through education or work experience is required. Fluency in Spanish and English spoken language and written communication is essential to this position. Candidates must have the ability to work independently with minimal supervision; strong attention to detail; and an ability to handle deadlines, confidential information and apply flexibility with priorities. Proficiency with MS Word, PowerPoint, Excel, and other MS Office and electronic mail software, and experience with electronic informational resources (including the internet and informational databases) is required.

Master’s degree and at least four years of experience in clinical research is preferred. Certified Clinical Research Professional Certification (CCRP) a plus. The candidate will ideally have familiarity with FDA and/or NIH regulatory reporting requirements and other regulatory functions, including centralized IRBs and have experience with protocol development. Prior experience in either a clinical research or observational study, particularly in a coordinating center setting, is preferred for successful integration into the multi-disciplinary team. Medical exposure or background is preferable. Absolute accuracy is required in the work of this position. Published results of the study depend upon accuracy in all phases of work. This position contributes to accuracy of work performed by all personnel on the study. This position maintains regular, ongoing contact with primary personnel involved in the study, in particular the Principal Investigator, Co-Investigators, faculty collaborators and the project manager. This person will need strong working relationships with other Coordinating Center staff in order to handle responsibilities that affect their duties and vice versa. Good judgment and discretion will often be needed, as well as an ability to prioritize and act quickly to deal with issues and research needs. Flexibility in dealing with immediate and long-term needs will require a wide variety of interactions and skill in organizing and follow-up. Confidentiality in this research program, as with all other Center research that involves human subjects, is essential. Typical examples of contacts by this position include the following:• Faculty investigator to discuss research and administrative issues, plan actions and respond to protocol;• CSCC researchers and project team members to identify and resolve problems, plan additional actions, review progress;• Study coordinators to provide and receive information in Spanish and English;• Clinical center principal investigators and study coordinators to evaluate and provide study related information in Spanish and English.

No