Regulatory Specialist I, Gerontology

Wake Forest Baptist Health

  • Winston-Salem, NC
  • Permanent
  • Full-time
  • 1 month ago
Job Description:JOB SUMMARYUnder limited direction, oversees the regulatory submissions and approvals within the Section on Gerontology and Geriatric Medicine to ensure research studies comply with all federal, state, and local regulations.EDUCATION/EXPERIENCEBachelor's degree in Education, Public Health, Basic Science, or a relevant clinical discipline with two years of research experience in coordinating and performing regulatory and/or data management activities for research studies and/or grants, especially clinical trials required; or, an equivalent combination of education and experience. Master's degree in a relevant discipline preferred.LICENSURE, CERTIFICATION, and/or REGISTRATIONMust complete the CITI certification for Biomedical Human Subject Research and Good Clinical Practice (GCP) if not already completed.ESSENTIAL FUNCTIONS * With guidance, assists with ensuring compliance with WFUHS IRB Standard Operating Procedures (SOP) and document applications.
  • Adheres to Guideline for GCP, federal, state, and local regulations, as well as WFBH policies and procedures. Leads quality improvement projects on an ongoing basis.
  • Assists with the preparation for internal and external inspections, audits and monitors visits.
  • Assists in assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition.
  • Assists the PI and other designated research staff in the preparation, submission, and maintenance of the study-related regulatory documents. Prepares and routes protocol documents and consent forms to the Institutional Regulatory Board (IRB). May also help prepare submissions to the FDA seeking new Investigational New Drug (IND) applications and/or IND exemptions as well as submissions and maintenance of clinicaltrials.gov.
  • Assists the PI with maintaining all study-related legal/financial documents in a confidential administrative file, if requested.
  • Assists with preparation and submission of data safety and monitoring reports to sponsor, FDA and IRBs.
  • Assists in study closure activities including scheduling of monitor closeout visit, preparation and collection of closeout documentation, and preparation of study files for distribution to long-term storage. Maintains long-term storage records and keeps PI and Sponsor informed of any changes in the status of study records.
  • Ensures the Office of Clinical Research builds an accurate budget and assessment calendar with input from the study team in OnCore (WISER). Submit amendments to keep WISER updated to reflect all changes in the protocol's status through the life of the protocol. Identifies and communicates important protocol issues to the PI in a timely manner.
  • Develops and documents quality control monitoring procedures and standards. Reviews assigned trials for adherence to the compliance guidelines set forth by WFBH.
  • Participates in scheduled team/department meetings.
  • Follows established Wake Forest Baptist Health and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
  • Performs other related duties as assigned or requested.
SKILLS/QUALIFICATIONS
  • Excellent interpersonal, oral, written, and listening communication skills
  • Attention to detail and accuracy
  • Demonstrates prioritization and organizational skills
  • Ability to manage multiple tasks with strict timelines
  • Proficiency with Microsoft Products, EPIC/Encompass, and OnCore (WISER) Clinical Trial Management System.
  • Basic computer skills
  • Ability to read and comprehend complex study documents and summarize key components in a succinct manner
  • Foster/promote a positive image and professional appearance
  • Sensitivity to intercultural relations
  • Sensitivity to the maintenance of confidentiality
WORK ENVIRONMENTClean, comfortable, office environment and some remote work is possible.About Us:Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem - that includes Brenner Children's Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians.Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing - for all.It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.About the Team:Mission, Vision and Culture CommitmentsMissionTo improve health, elevate hope and advance healing - for all.VisionTo be the first and best choice for care.Culture CommitmentsWe create a space where all BelongWe Work as One to make great things happenWe earn Trust in all we doWe Innovate to better the now and create the futureWe drive for Excellence - always

Wake Forest Baptist Health