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 File Maintenance Specialist II will work in conjunction with or under the supervision of a Lead and/or Manager Level. Site File Specialist may be assigned to support start-up projects, as needed.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Performs ad -hoc reviews of investigator study files for expired documents.
Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required and regionally applicable.
Communicates directly with the site, with the Site File Associates/Specialists, or local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents. May tracks any action items to CRAs/sites in CTMS.
Oversees the Site File Associate(s)
Reviews eTMF reports on a regular basis to ensure all documents have been filed according to IQVIA Biotech SOPs.
Ensure Periodic Site File Review are completed as per the IQVIA Biotech SOPs.
May review 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.
In NA, 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).
Responsible to send updated documents (e.g. 1572, FDF) to client on a monthly basis as required.
Responsible for review of the ongoing IRB/Ethic Committee (EC) documentation (i.e. IRB continuing review, Amendment approval) and update tracking system as necessary and as applicable to region.
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 as required.
Supports internal, external and client audits of the Investigator Site Files
Provides updates to manager on a regular basis and communicates any out of scope activities.
Adheres to study timelines, document/escalate study challenges and communicates update to PM/ Manager.
Attends Client meetings as needed & may act as regional lead, as applicable
Supports in creating study specific template documents, per IQVIA Biotech SOP.
For NA only, serves as IQVIA Biotech liaison with Central IRBs and completes IRB submissions.
Participates in financial and/or resource forecasting, as applicable.
Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
Good Knowledge of clinical research process and medical terminology
Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
Excellent organizational and interpersonal skills
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
Working knowledge of current ICH GCP guidelines and applicable regulations
General understanding of audit preparation
Ability to independently problem-solve and recommend solutions
Ability to mentor junior level staff
Ability to work independently, prioritize and work with a matrix team environment is essential.
Working knowledge of Word, Excel is required.
Limited travel may be required
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
BS/BA/BSc, or equivalent, plus 2 years of related experience; regulatory document review experience preferred
Equivalent combination of education, training and experience
US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Non-US: Not applicable.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com