ExecuPharm FSP-Regulatory Document Reviewer

Job Title: ExecuPharm FSP- Regulatory Document Reviewer (RDR)

RDR Responsibilities:

• Comply with all ICH GCP Guidelines, FDA Regulations & Guidance Documents, PI’s SOPs, PI Working Instructions or “WI(s), protocol, amendments and guidelines.

• Attend the Sponsor RDR orientation and trial training sessions or bi –weekly meetings.

• For assigned trials collect, review and negotiate documents for assigned investigator site(s) and maintain working files of Regulatory Documents on the PI supplied computer.

• Send reviewed and approved quality regulatory documents to the PI ”Clinical Trial Master File” or “CTMF” in accordance with BIPI SOPs.

The RDR will maintain working files for documents relating to the trial, such as, notes, telephone logs, worksheets.

• PI will have the right to QC or audit, at reasonable times, the Regulatory Document Files.

• The RDR will promptly send final regulatory documents to PI Clinical Trial Master File (CTMF) within 3 days of approval.

Site Regulatory Document Collection:

• The RDR may assist with the development of regulatory document package and distribution activities to meet project timelines.

• The RDR may develop the initial Central IRB package, and under supervision, correspond with submit, and liaison with the Central IRB to discuss Trial start-up expectations and submission deadlines.

• The RDR will bring to the RDR Manager’s attention questions/issues pertaining to sites ability to address the documents in a timely manner as well as pertinent regulatory document questions.

• The RDR Manager will assign the RDR to mutually agreeable tasks pertaining to the startup and trial conduct regulatory document processes such as creating trial Regulatory Document worksheets, maintaining question and answer logs or other tracking logs and reports.

• PI will make available to the RDR the trial regulatory documents electronically, or via access of a secure portal. The RDR will review, negotiate and release quality regulatory documents for the trial according to the timelines.

• The RDR will work with their assigned Investigator Sites to collect, negotiate and perform a quality review of regulatory documents in a timely manner and according to regulatory requirements and PI’s RDRG guidelines.

• The RDR is expected to contact assigned Investigator Site(s) via telephone within 24- 48 hours or sooner after Regulatory Document File distribution to verify package receipt or access.

• RDR will contact Investigator Sites at a minimum once a week by telephone or more frequently when required to assist Investigator Sites with regulatory document completion and expedite the collection process.

• The RDR, using the Sponsor’s electronic weekly report template will send the RDR Manager or designee, an update detailing the progress made with their assigned sites and/or issues. The RDR is required to submit this update on a specific day of the week through the duration of trial regulatory document collection process for their assigned Investigator Sites. In cases where a portal or other system is used the expectation is that the RDR will update the system real-time as trial regulatory documents are being worked on, for all assigned Investigator Sites. Weekly update reports may also be required.

QualificationsRequirements:

4 Year college degree or relevant experience

Desired Experience, Skills and Abilities:

• Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trial process, meet deadlines and keep a trial /site on track along with any other qualifications provided by Sponsor

• Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: Share Rooms, Clinical Trial portals, Central IRB portals, Time reporting portals, Learning portals, Access Databases, Microsoft Excel, Microsoft Skype, Adobe Acrobat Professional and scanning software etc.

• Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices.

• Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.

• Represent Sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Site Monitoring staff, other departments within Clinical Operations and if required clinical trial vendors.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.