Soc/Clin Research Specialist
Permanent Staff (SHRA)Is this an internal only recruitment?:
Soc/Clin Research Specialist - JourneyWorking Title:
Soc/Clin Research SpecialistPosition Number:
P012567Budgeted Hiring Range:
$50,362 - $65,721Pay Band Information:
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.Salary Grade Equivalent:
Full-Time Time-LimitedIf time-limited, estimated duration of appointment:
1 yearHours per week:
Monday – Friday (8am – 5pm)Department Name and Number:
Peds-Children's Research Inst-412019Date First Posted:
Chapel Hill, NCPosition Posting Category:
Research ProfessionalsDepartment Description:
The UNC Department of Pediatrics, Children’s Research Institute (CRI) supports research focused on childhood diseases and disorders in the Department and across the University, providing infrastructure for facilitating interdisciplinary and collaborative research efforts, advancing the health of children in NC and beyond.
Research efforts focused on human subjects from pediatric populations are supported by the CRI Pediatric Clinical Research Unit (Peds CRU). CRI Peds CRU provides pediatric clinical researchers infrastructure, including program management, regulatory support, data management, sample processing, training/mentoring, community building, space to conduct visits, and study coordinators.
The CRI serves as a hub, reaching out across the Department of Pediatrics, School of Medicine, the University of North Carolina, and beyond to actively assemble cross-disciplinary researchers. Peds CRU studies include diagnostic tests, early phase therapeutics, cohort studies, and randomized trials, pairing new investigators with experienced ones in the collaboration of these studies. The Department’s organizational component consists of 14 divisions, various off campus sites and additional cost centers, all of which are invited to participate in our clinical trial initiatives.Equal Opportunity Employer:
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.Position Description:
This position directly supports the diverse clinical research activities of the UNC Children’s Research Institute through participation in multiple research projects. The primary purpose of this position is to coordinate and manage clinical trials, providing pediatric clinical researchers the infrastructure and resources to conduct clinical research. The Study Coordinator has direct responsibility for day-to-day activities of several pediatric clinical trials involving both drugs and medical devices. Responsibilities include patient recruitment, study procedures, administration of survey/questionnaires and data collection and maintenance. This Study Coordinator in this position will navigate responsibilities based on protocols currently underway and those in development. Other responsibilities include the initiation and maintenance of IRB and other regulatory procedures.Minimum Education and Experience Requirements:
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, Knowledge and Abilities:
The coordinator will demonstrate full knowledge of clinical research principles, methods of data collection and analysis to independently manage all clinical protocols. The coordinator will demonstrate basic knowledge of statics and related information technology to analyze and report data collected during the course of clinical research. The coordinator must understand all aspects of GCP (Good Clinical Practice) to conduct clinical studies under the regulatory guidelines of the FDA and institutional IRB.
Skills include: 1) ability to understand protocols and teach them to faculty, fellows, and clinic personnel, 2) patient education, 3) basic knowledge of drug administration, 4) use of computers and test equipment.Preferred Qualifications:
Experience in pediatric or adult clinical research is strongly desired but not required. Additional preferences, but not requirements, include recent direct experience with:
• Clinical trials (including experience with UNC IRB processes, FDA regulatory requirements, ICH GCP guidelines, and EPIC)
• Evaluating protocols and consents for potential changes, when warranted, for feasible implementation at our study location in the targeted population
• Coordinating NIH multi-center clinical trials, including study startup, recruitment, study management, data collection, and closeout
• Competitive enrollment studies
• Monitoring vital signs (heart rate, blood pressure)
• Developing and negotiating budgets with industry partners
Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) certification is strongly desired.
Candidates who have worked with children, built rapport with families of diverse backgrounds, and are self-motivated are highly sought.