Regulatory Specialist I, Gerontology
4 weeks ago
Overview
JOB SUMMARY
Under 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/EXPERIENCE
Bachelor'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 REGISTRATION
Must 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 ENVIRONMENT
Clean, comfortable, office environment and some remote work is possible.
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