What are the responsibilities and job description for the Regulatory Specialist II, Comprehensive Cancer Center position at Wake Forest Baptist Health?
Job Summary
Under the direction of the Manager of Regulatory Affairs and Compliance, the Regulatory Specialist II performs administrative and coordinative work directed toward the regulatory and compliance activities of assigned Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) clinical trials by working closely with Principal Investigators and other Clinical Trials staff members. This position is responsible for the planning, development, implementation and evaluation of certain phases of the assigned studies; translate planning and design decisions into concrete activities and tasks to be undertaken and set priorities as appropriate. The Regulatory Specialist II position provides operational support for regulatory compliance and is able to independently provide regulatory support to the Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) PI and research sites conducting multiple FDA-regulated or other clinical trials. This position is able to successfully manage a workload that includes all trial types and mentor other Regulatory Specialists. This classification requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the projects. The Regulatory Specialist II works with moderate to minimal supervision and direction from the Manager of Regulatory Affairs and Compliance.
Education/Experience
- Bachelor's degree and three or more years as a Regulatory Specialist or equivalent experience.
Licensure, Certification and/or Registration
- RAPS, SOCRA or ACRP Certification preferred
- Must complete the CITI certification for Human Subject Research if not already completed
- All additional required training for research staff per institutional requirements, if applicable
Essential Functions
Compliance
- With guidance from PI and Regulatory Affairs and Compliance (RAC) leadership, assist with ensuring compliance with WFUHS IRB Standard Operating Procedures (SOP) and document applications.
- Adhere to Guideline for Good Clinical Practice (GCP), federal (FDA and DHHS), state, and local regulations, as well as AHWFBCCC policies and procedures.
- Assist with the preparation for internal and external inspections, audits and monitor visits.
- Assist in assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition.
Study Implementation and Maintenance
- Work with the PI and other research staff to prepare, submit, and maintain the following IRB, FDA and regulatory essential documents (when required):
- Initial protocols;
- Initial and modified consent form documents;
- Protocol modifications/amendments;
- FDA submissions, including IND/IDE Annual Report;
- Annual, interim and final IRB reports;
- FDA forms 1572, 1571, and 3674;
- Protocol deviations;
- Serious adverse events and Unanticipated Problems;
- Current and amended Investigation Drug Brochures;
- Significant study related correspondence, reports, and letters;
- Current laboratory certifications and normal reference ranges;
- Research staff CVs and licenses, training materials, and certifications;
- Maintain training and delegation logs for research personnel.
- Participate in study review meetings to identify logistical issues with proposed protocols to ensure the ability to properly coordinate and execute protocol requirements.
- Assist with data entry of study activities into database programs to track pertinent study regulatory activity (e.g., study start-up, protocol violations/deviations, serious adverse event reports, IRB history, FDA history, protocol training, etc.).
- Assist the PI and research personnel in the resolution of compliance queries.
- Assist in study status updates and study closure activities including preparation and collection of close-out documentation, resolution of outstanding regulatory queries, and preparation of study files for archival/long-term storage.
- Maintain long-term storage records and keep PI and Sponsor informed of any changes in the status of study records.
- Perform duties such as filing, photocopying, faxing, and distributing study-related documents.
- Develop and document quality control monitoring procedures and standards.
- Review assigned trials for adherence to the compliance guidelines set forth by WFBCCC and NCI.
- Identify and communication important protocol issues to the supervisor in a timely manner.
- Assists in the development, improvement, and review of Standard Operating Procedures and guidelines to ensure procedural compliance.
- Provides regulatory-related educational and technical assistance to research staff including orientation and mentoring of new research teammates.
Personnel Management
- Provide staff relief as required to meet the demands of the department
- Participate in scheduled team/department meetings
- Lead or participate in compliance improvement projects on an ongoing basis
Follows established Atrium Health 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 and Qualifications
- Proficiency with Microsoft Products.
- Basic computer skills required.
- Excellent interpersonal and communication skills (verbal, written, and listening skills).
- Proficient in the use of Clinical Trial Management Systems (OnCore) preferred.
- Demonstrate prioritization and organizational skills.
- Ability to read and comprehend complex study documents and summarize key components in a succinct manner.
- Attention to detail and accuracy.
- Ability to manage multiple tasks with strict timelines.
- Foster/promote a positive image and professional appearance.
- Sensitivity to intercultural relations.
- Sensitivity to the maintenance of confidentiality.
