Clinical Research Coordinator - RECODE Lead

University of North Carolina- Chapel Hill
February 06, 2023
Offerd Salary:$60,000 - $89,371
Working address:N/A
Contract Type:Open-ended
Working Time:Full time
Working type:N/A
Ref info:N/A
Posting Information

Posting Information

Department Peds-Children's Research Inst-412019

Career Area Research Professionals Is this an internal only recruitment? No Posting Open Date 01/30/2023 Application Deadline 02/06/2023 Position Type Permanent Staff (SHRA) Position Title Soc/Clin Research Specialist - Advanced Salary Grade Equivalent GN14 Working Title Clinical Research Coordinator - RECODE Lead Position Number 20053239 Vacancy ID P016804 Full-time/Part-time Permanent/Time-Limited Full-Time Permanent If time-limited, estimated duration of appointment Hours per week 40 Work Schedule

Monday – Friday (8am – 5pm)

Work Location Chapel Hill, NC Position Location North Carolina, US Hiring Range $60,000 - $89,371 Pay Band Information

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

Position Summary Information

Primary Purpose of Organizational Unit

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.

OUR VISION Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.

OUR MISSION Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.

Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.

Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

Position Summary

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 clinical trials are supported by the CRI Pediatric Clinical Research Unit (Peds CRU). CRI Peds CRU provides pediatric clinical researchers the infrastructure to conduct clinical trials, 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.

The RECODE Study Lead will be a resource for the Clinical/Social Research Specialist team and will administer and provide technical expertise for research projects across Divisions in the Department of Pediatrics, with majority of responsibility to oversee and execute the Recode project and other studies within Pulmonary, but also ad hoc responsibilities including but not limited to projects within Endocrinology, Gastroenterology, Rheumatology, Allergy/Immunology, Critical Care as needed. The primary purpose of this position is to provide oversight, project management, and execution of pulmonary directed projects. This includes, but is not limited to:

  • Protocol development, review, and training
  • Independent study preparation and start up
  • Study maintenance and evaluation
  • Continuous evaluation for maximizing and meeting goals for patient recruitment
  • Sample collection
  • Compliance through tracking, monitoring, and auditing of clinical research studies
  • Internal quality assurance audits and regulatory submissions
  • This position will also be responsible for managing multiple projects and training additional staff on protocol and manual of operations.

    The Clinical/Social Research Specialist works closely with the Leadership Team of the Clinical Research Unit and reports directly to the CRI Clinical Trials Director.

    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.

    Required Qualifications, Competencies, and Experience

    The candidate should have excellent verbal and written communication skills with ability to interact with clinical investigators, laboratory personnel, study sponsors, IRB, Office of Clinical Trials, and support staff. Working knowledge of medical terminology, techniques and methodologies used in developing, coordinating and managing clinical research projects. Applicant must have a working knowledge of FDA Code of Federal Regulations (CFR) and International Conference on Harmonisation Good Clinical Practice (ICH GCP) as well as familiarity with local, state and federal guidelines governing clinical trials. The candidate must be experienced in initiating, maintaining and updating protocols with central and local IRBs and minting the appropriate regulatory documents. Applicant should have a working knowledge of database management and spreadsheets. Ability to learn quickly, work independently and efficiently with minimal supervision, prioritize tasks, and work under deadline pressure. Leadership experience is necessary. Flexibility is required for intermittent evening and weekend hours as needed for patient enrollment after normal business hours.

    Ideal candidate has demonstrated ability to multitask and work on different projects concurrently. In addition to demonstrated ability to work on projects in different phases of completion (eg, start-up, actively recruiting, data analysis) and provide seamless coverage in taking on and handing off studies, to minimize disruption in project.

    Preferred Qualifications, Competencies, and Experience

    Experience with clinical research (including the UNC IRB processes, FDA regulatory requirements, ICH GCP guidelines, ACRP or SOCRA certification) is strongly desired.

    Required Licenses/Certifications Special Physical/Mental Requirements Campus Security Authority Responsibilities

    Not Applicable.

    Position/Schedule Requirements Special Instructions Quick Link https: //

    Contact Information

    Office of Human Resources Contact Information

    If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to [email protected]

    Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

    Equal Opportunity Employer 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.

    Applicant Documents

    Required Documents

  • Curriculum Vitae / Resume
  • Optional Documents

  • Cover Letter
  • List of References
  • Posting Supplemental Questions

    Required fields are indicated with an asterisk ().

  • Please select the response below that best describes your experience/education for the Social/Clinical Research Specialist position.
  • Bachelor's in a discipline related to the field assigned and at least 1 year of related training or experience.
  • Associate's, Bachelor's, Master's, Doctorate in an unrelated field and at least 5 years of related training and/or experience.
  • Master's and/or Doctorate in a discipline related to the field assigned.
  • Associate's in a discipline related to the field assigned and at least 3 years of related training or experience.
  • Combination of post-high school education and experience to equal at least 5 years of experience related to the field assigned (ex: 1 year towards a degree and 4 years experience).
  • Did not complete high school but have a combination of high school education and related experience to equal at least 9 years (ex. 3 years of high school and 6 years of experience).
  • None of the above
  • How many years of clinical research or other relevant experience do you have?
  • (Open Ended Question)

  • Briefly describe your experience working with children and families in a clinical and/or research setting.
  • (Open Ended Question)

  • Please describe your experience with project leadership.
  • (Open Ended Question)

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