Sr Study Start Up Specialist , ICF Reviewer ( Home-Based , Latam, United States) - IQVIA Biotech
IQVIA Holdings Inc.
IQVIA Biotech is now hiring for a Sr Study Start-Up Specialist specializing in ICF review. Candidates can either be located in Latam or the United States. Must have strong ICF review experience and working with Master and Country level templates.
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A Sr. SSUS may be assigned to one or more start-up projects and is able to work independently on a project with minimal supervision.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Leads SSU activities and updates during weekly client teleconferences and internal team meetings.
• Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
• May provide a role in the coordination of the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
• May create and disseminate Confidential Disclosure Agreements (CDAs)/ Questionnaires to sites and follow up accordingly to ascertain interest and to meet study timelines.
• May review CDAs on behalf of sponsor according to country and sponsor specific requirements, seeking legal/management review when required.
• May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
• Assists sites and/or leads a team with local IRB/ethics committee submissions.
• Serves as IQVIA Biotech liaison with central IRBs/REBs/ECs, as applicable.
• Creates templates for regulatory documents specific to local and central Institutional Review Board (IRB) /ethics committee submission requirements. Assembles and distributes regulatory documents to sites either directly or through local CRAs in specific countries.
• Contacts sites directly, or through local representative (country dependent), as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.
• May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.
• Liaise with legal and internal team to secure authorization of site contracts.
• Coordinate document translations required for CEC/EC submissions, as needed.
• Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA), CEC and Ethics Committee (EC) submission documentation, and similar information for other related organizations, for the assigned countries.
• Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
• Notifies the Regulatory Advisor representative (RA-R) when initial essential documents are available for review. Works with the RA-R to resolve any concerns.
• Manages quality and regulatory compliance documentation among investigational sites.
• Adheres to study timelines, documents study challenges and communicates updates to Project Manager and SSU Lead/Management.
• Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
• Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.
• Assures that team members understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
• Identifies out of scope activities to SSU Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
• Participates in financial and/or resource forecasting, as applicable.
• Responsible for transitioning sites from SSU to File Maintenance representative.
• Update study start-up timeline tool, per IQVIA Biotech SOP.
• Participates in reviewing Safety and Regulatory management plans.
• Leads in training and development of junior staff.
• Mentors junior staff.
• Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
• Knowledge of clinical research process related to study start-up and medical terminology.
• Knowledge of Regulatory and Central/Local ethic submission processes for assigned countries.
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
• Excellent organizational and interpersonal skills with track record for attention to detail.
• 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.
• Ability to reason independently, assess and recommend specific solutions in clinical settings.
• Experience of mentoring entry level SSU staff in above activities.
• Excellent verbal and written communication skills required for assigned countries.
• Ability to work independently, prioritize and work with a matrix team environment is essential.
• Working knowledge of ICH/GCP Guidelines
• Working knowledge of Word, Excel is required.
• Current country Regulatory Intelligence knowledge.
• Ability to travel periodically if needed
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
MINIMUM RECRUITMENT STANDARDS:
• Bachelor’s degree (or equivalent), preferably in science or related field and 3 - 5 years relevant experience including 2 years of regulatory & study-start up experience
• Equivalent combination of education, training and experience
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 [email protected] to arrange for such an accommodation.