Site File Specialist I - IQVIA Biotech

IQVIA Biotech is now hiring for a Site File Specialist I .

BASIC FUNCTIONS:

Responsible for the quality and regulatory compliance of Investigator Site Files (ISF) during the file maintenance period of the study.  Work with both internal and external teams to assure good communication regarding documentation processing.  Assure documents maintained for a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.  A Regional Site File Specialist I will work in conjunction with or under the supervision of a more senior Specialist and/or Manager Level.   Site File Specialist may be assigned to support start-up projects, as needed. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Reviews documents received from sites, IRBs/ECs and CRAs to ensure compliance with GCP and IQVIA Biotech’s standard operating procedures from maintenance through close-out phase, as applicable.
• Manages ongoing IRB/ethics continuing renewals, where applicable, and reviews investigator study files for expired documents.
• Communicates directly with the site, or local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents. 
• Tracks any action items to CRAs/sites in CTMS or alternative process as per the client requirement.
• Reviews eTMF reports as applicable to ensure all documents have been filed according to IQVIA Biotech SOPs.
• Ensures Periodic Site File Reviews are completed as per the IQVIA Biotech SOPs.
• Conducts regularly scheduled investigator site file reviews on assigned project(s) to ensure compliance with GCPs and IQVIA Biotech’s standard operating procedures. 
• Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required. 
• For NA only, supports the review of site specific ICFs as changes occur during the study.  Completes ICF checklists and files IRB approved ICFs throughout the study.  Maintains accurate and complete site specific ICF template tracking.
• Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).
• Submit ongoing regulatory documents to clients as needed.
• Follows the appropriate IQVIA Biotech and/or sponsor SOPs during conduct of the study.
• Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs, or Sponsor SOPs if required.
• Awareness of study timelines, escalation pathways and the communication needs of PM/ Manager.
• Provides updates to Lead or Manager on a regular basis.
• Supports in creating study specific template documents, per IQVIA Biotech SOP.
• For NA only, may serve as IQVIA Biotech liaison with Central IRBs and completes IRB submissions.
• Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

• Basic understanding of clinical research process and medical terminology
• Good written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple competing priorities within various clinical trials
• Awareness of current ICH GCP guidelines and applicable regulations
• Ability to work independently, prioritize and work with a matrix team environment is essential.
• Working knowledge of Word, Excel is required. 

PHYSICAL REQUIREMENTS:

• Limited travel may be required
• Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc, or equivalent, plus 6 months of related experience; regulatory document review experience preferable
• Equivalent combination of education, training and experience

CLASSIFICATION:

• US:  This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.