Regulatory Specialist I

Job Description Summary:

Under the direction of the Oncology Research Regulatory Affairs and Compliance, performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned clinical trials by working closely with Principal Investigators (PI) and other clinical trial staff members. Responsible for the planning, development, implementation and evaluation of certain phases of the assigned studies. Translates planning and design decisions into concrete activities and tasks, setting priorities as appropriate. Under limited direction, provides operational support for regulatory compliance to research sites conducting multiple FDA-regulated or other clinical trials. Assignments will be adjusted gradually to add increased responsibility based on demonstrated competency. Requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the projects.

EDUCATION/EXPERIENCE:

• Bachelor's degree in Education, Public Health, Basic Science, or a relevant clinical discipline

• 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.

• Experience in budget and financial tracking/monitoring, patient accounting/departmental billing, business, or accounting preferred.

LICENSURE, CERTIFICATION, and/or REGISTRATION:

• SOCRA or ACRP Certification preferred.

• Must complete the CITI certification for Human Subject Research if not already completed.

• All additional required training for research

ESSENTIAL FUNCTIONS:

• Assists with ensuring compliance with WFUHS IRB Standard Operating Procedures (SOP) and document applications.

• Adheres to Guideline for Good Clinical Practice (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.

• Schedules and hosts Site Selection Visits and Site Initiation Visits, as applicable.

• 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 WFBCCC Protocol Review Committee (PRC) through OnCore (WISER).

• Prepares and negotiates a budget that is mutually agreeable to the institution and sponsor. Assists the PI with maintaining all study-related legal/financial documents in a confidential administrative file, if requested.

• Assists with data entry of study activities into a database program to track pertinent study activity (i.e., study enrollment, consents, protocol violations/deviations, serious adverse event reports, and IRB history). Assists the PI and research personnel in the resolution of data queries, if applicable.

• 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 keep PI and Sponsor informed of any changes in the status of study records.

• Creates protocol records in OnCore and builds an appropriate protocol calendar with input from the Research Nurses and Clinical Studies Coordinators, if required.

• Keeps OnCore updated to reflect all changes in the protocol's status through the life of the protocol.

• Identifies and communicates important protocol issues to the supervisor 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. Provides staff relief as required to meet the demands of the department.

• 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/WakeOne, 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