Regulatory Associate II

Functions and Tasks Clinical Research Protocol Regulatory Administration

• Prepare clinical research protocols and related regulatory documents for submission to the Human Research Protection Program HRPPIRB.
• Summarize sources of data and information, and review the data and information obtained to create documents.
• Maintain working knowledge of the policies and procedures of the Human Research Protections Program HRPP and of the VA Human Subjects Office review these policies and procedures under the general supervision of the Medical Director of Regulatory Affairs and as needed, consult with HRPP analysts and the CTO Quality Assurance Manager to resolve issues.
• Maintain working knowledge of the policies, procedures and regulations of the FDA and the National Cancer Institute pertaining to adverse event reporting and the informed consent of human subjects.
• Review, analyze and interpret sponsors clinical research protocol and Investigator Brochure and abstract key information from these documents in order to assist with preparing Research Plan application in format required by HRPP. This process requires summarizing large quantities of data 200300 pages into concise and condense applications of approximately 20 pages.
• Consult with Principal Investigator, Clinical Research Project Manager and Sponsor as needed to assist with preparing Research Plan and related documents.
• Prepare Investigational Drug Fact Sheets using sponsors protocol, Investigator Brochure, and pharmaceutical literature as needed.
• Create Informed Consent Documents for human subjects in a manner that complies with HRPP policies and procedures, FDA regulations covering consent of human subjects, and sponsors requirements. Edit as needed to make changes that satisfy HRPP, sponsor, and investigator. Compose wording to describe in language understandable to a layperson the study procedures and treatments, including risks of the study drug.
• Prepare and submit protocol amendments to the HRPP, including modifications to the Research Plan and Informed Consent Document. Notate key changes to the protocols. Submit to the Cancer Centers Protocol Review and Monitoring Committee PRMC for review as needed.
• Submit Investigator Brochures and IND Safety Reports to the HRPP summarize key changes.
• Prepare annual reports on the progress of the trial. Determine source of data and information to create the report including sponsor, investigator, clinical research project manager and coordinators, and adverse event reports, and summarize the information in order to submit the reports.
• Develop responses to HRPP questions and stipulations in order to obtain HRPP approval of the trial by performing the following duties.
• Find sources of data and information needed to answer the questions and to resolve issues compose responses. Sources of information would include the Principal Investigator, Clinical Research Project Managers, the studys sponsor commercial sponsors and the National Cancer Institute cooperative groups, staff at the HRPP and CTO, as well as the study protocol, HRPP policies and procedures, and applicable regulations.
• Negotiate with the parties involved to arrive at mutually acceptable solutions in order to obtain HRPP approval of the trial as needed.
• Maintain the regulatory files for the CTOs clinical trials in accordance with the CTOs policies and procedures.
• Prepare files for monitoring visits and internal external audits, including those by the Cancer Center CTO, Cancer Center DSMB, VA Compliance Office, commercial sponsors, National Cancer Institute, and its cooperative groups.
• Interact with a variety of internal and external contacts including Cancer Center investigators and staff Human Research Protections Program staff VA Human Subjects Protections staff divisiondepartment heads federal, state and nonprofit agencies corporate sponsors of research and contract research organizations.
• Maintain large database tracking protocol information, including IRB and Cancer Center review process.
• Develop and produce protocol status reports, as needed.
• Independently coordinated and accountable for the overall administration and outcome of one or more clinical studies, typically requiring advancedlevel knowledge and skills.

Communication

• Responsible for the complex function of the regulatory program within the CTO. Coordinating and management of all regulatory activities and resources to ensure timely execution of tasks.
• Interact with a variety of internal and external contacts including Cancer Center investigators and staff Office of IRB Administration staff VA Human Subjects Protections staff Clinical Trials Administrative Services staff, divisiondepartment heads federal, state and nonprofit agencies corporate sponsors of research and contract research organizations.
• Liaise with Principal Investigator and Key Personnel associated with the projects to timelines, resolve delays, concerns, and provide detailed updates.
• Work closely and collaboratively with clinical project management staff to plan and delegate collaborative tasks for study coordinators and regulatory associates to ensure completion of research projects in an efficient manner. Critically evaluate and contribute original ideas on methodological, technical, and theoretical aspects of all parts within the CTO.
• Review and change ongoing projects as needed.

Regulatory Oversight

• Responsible for the oversight, planning and direction of the clinical regulatory area.
• Develop, implement, and update procedural and training manuals for the Regulatory Associates and Regulatory Department. Develop and implement guidelines for maintenance of all CTOAffiliate regulatory documents. Responsible for the definition and execution of procedures to assure research and other activities subject to regulatory review are being conducted in accordance with internal, national and international standards and guidelines.
• Responsible for training of activities relating to study implementation, regulatory issues, quality management and data entry. Train new CTO staff in all areas of IRB submissions and FDA compliance procedures.
• Responsible for the definition and execution of procedures to assure research and other activities subject to regulatory review are being conducted in accordance with internal, national and international standards and guidelines.
• Collaborate and communicate with CTO Administrator and CTO Deputy Director to ensure all parties are informed of any potential problems within the affiliate structure andor procedures and make recommendations as needed.
• Train and assign work to new and continuing employees.

FDA Applications

• Prepare and file IND applications or IND exemptions to the FDA on behalf of the clinical investigators.
• Prepare and file IDE to the FDA on behalf of cancer center investigators.
• Responsible for ensuring the clinical research trials are entered into the ClinicalTrials.Gov database in compliance with recent regulatory requirements.
• Analyze and summarize sources of data and information, and review the data and information obtained to create documents.
• Extensive knowledge of FDA CFR and the National Cancer Institute pertaining to filing NDA applications and serious adverse event reporting.
• Design and prepare Investigational Drug Fact Sheets using sponsors protocol, Investigator Brochure, and pharmaceutical literature as needed.

Qualifications

• Drafting negotiations, informed consent IC
• IRB submissions
• Submissions to scientific review
• Phase 1 experience
• Oncology Clinical Trial Experience