Regulatory Specialist I, Comprehensive Cancer Center

Overview

Job Summary: 

Under the direction of the Manager of Budget, Regulatory and Data Management Services, the Regulatory Specialist I performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) clinical trials by working closely with Principal Investigators and other Clinical Protocol and Data Management (CPDM) 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 I position provides operational support for regulatory compliance. Under the direction of the manager and mentored by an experienced Regulatory Specialist II or III, the Regulatory Specialist I provides regulatory support to the WFBCCC PI and research sites conducting multiple FDA-regulated or other clinical trials.  Assignments will gradually be adjusted to add increased responsibility based on demonstrated competency. This classification requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the projects.  Regulatory Specialist I will work with an assigned mentor on a regular basis and in consultation with the PI. 

Education/Experience: 

Minimum Acceptable Qualifications:

1. Bachelor's degree in education, public health, basic science, or a relevant clinical discipline. 
2. Two years of research experience in coordinating and performing regulatory and/or data management activities for research studies and /or grants, especially clinical trials.
3. An equivalent combination of education and experience.

Additional Desirable Qualifications:

1. Master's degree in a relevant discipline.
2. Budgetary and financial tracking/monitoring experience.
3. Patient accounting/departmental billing experience.
4. Business and/or accounting experience.

Reports To:  Manager, Clinical Research Operations, Clinical Protocol and Data Management, Comprehensive Cancer Center 

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 WakeOne training for research coordinators

Essential Functions:

Compliance

• With guidance from PI and CPDM Directors, assist with ensuring compliance with WFUHS IRB Standard Operating Procedures (SOP) and document applications.
• Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, as well as WFBCCC 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

• Works in conjunction with Regulatory Specialist mentor to schedule and host Site Selection Visits and Site Initiation Visits.
• With direction from the PI, prepare the following IRB documents (when required): 
  • New protocol applications;
  • Consent form draft;
  • Protocol modifications/amendments;
  • Adverse Event/Serious Adverse Event summary for annual report;
  • IND Safety Report Summary for annual report;
  • Annual, interim and final IRB reports. 
• Assist the PI and other designated research staff in the preparation, submission, and maintenance of the following study-related regulatory documents: 
  • Current and obsolete versions of protocol and consent forms; 
  • FDA form 1572 and/or 1571; 
  • Protocol violations/deviations; 
  • Serious adverse events;
  • Current and obsolete Investigation Drug Brochures; 
  • Documentation of IRB submissions and related correspondence, reports, and letters; 
  • Current laboratory certifications and normal reference ranges; 
  • Research staff CVs and licenses, training materials, and certifications; 
  • Maintain training and education documentation for research personnel.
  • Test article accountability forms, signature logs, etc.
• Prepare and route protocol documents and consent forms to the WFBCCC Protocol Review Committee (PRC) through OnCore (WISER). 
• Participate in the Operational Protocol Services (OPS) meeting to identify logistical issues with proposed protocols to ensure the ability to properly coordinate and execute protocol requirements.
• Prepare and negotiate a budget that is mutually agreeable to the institution and sponsor.
• Assist the PI with maintaining all study-related legal/financial documents in a confidential administrative file, if requested.
• Coordinate with the PI regarding maintenance of regulatory IRB and other documentation and procedures.
• Assist 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). 
• Assist the PI and research personnel in the resolution of data queries, if applicable.
• Assist in study closure activities including scheduling of monitor close-out visit, preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage. 
• Maintain long-term storage records and keep PI and Sponsor informed of any changes in the status of study records. 
• Order and maintain adequate supplies for the projects, when required.
• Perform duties such as filing, photocopying, faxing, and distributing study-related documents. 
• Create protocol records in OnCore (WISER) and build an appropriate protocol calendar with input from the Research Nurses and Clinical Studies Coordinators.
• Keep OnCore (WISER) updated to reflect all changes in the protocol’s status through the life of the protocol.
• 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.

Personnel Management

• Provide staff relief as required to meet the demands of the department
• Participates in scheduled team/department meetings
• Leads quality improvement projects on an ongoing basis
• 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 and Qualifications:

1. Proficiency with Microsoft products.
2. Basic computer skills required.
3. Excellent interpersonal and communication skills (verbal, written, and listening skills). 
4. Demonstrate prioritization and organizational skills. 
5. Ability to read and comprehend complex study documents and summarize key components in a succinct manner. 
6. Attention to detail and accuracy.
7. Ability to manage multiple tasks with strict timelines.
8. Foster/promote a positive image and professional appearance.
9. Sensitivity to intercultural relations.
10. Sensitivity to the maintenance of confidentiality.