Nancy Patel
Ahmedabad
Summary
Dynamic Clinical Trial Assistant with proven expertise at IQVIA in regulatory compliance and clinical documentation. Skilled in managing complex clinical trial processes and fostering strong relationships with stakeholders. Adept at ensuring audit readiness and enhancing site performance metrics, contributing to successful project outcomes and timely submissions.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Clinical Trial Assistant
IQVIA
Ahmedabad
08.2015 - 11.2023
- Assist Clinical Research Associates (CRAs), In-house Clinical Research Associate (iCRA), and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Collaborate with the Clinical Project Manager (CPM), CRAs/iCRAs, and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with the periodic review of study files and completeness. - Collaborate with CRAs/iCRAs and RSU on the preparation, handling, and distribution of Clinical Trial Supplies, and maintenance of tracking information.
- Coordinate the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- Assist in training and orienting new staff. Acted as a mentor for less-experienced CTAs.
- I had accompanied CRAs on-site visits to assist with clinical monitoring duties upon completion of the required training and with the required approval.
- Perform assigned administrative tasks to support team members with clinical trial execution.
- Provide administrative and operational support for clinical studies from start-up through close-out.
- Assist in the preparation, collection, distribution, and tracking of essential clinical trial documents (e.g., Investigator Site Files, regulatory documents).
- Maintain and update the Trial Master File (TMF) in accordance with regulatory and sponsor requirements.
- Coordinate and schedule study-related meetings, teleconferences, and site visits.
- Support the tracking and management of clinical trial supplies and materials.
- Manage correspondence with study sites, vendors, and internal stakeholders.
- Assist in the review and processing of clinical trial invoices and budgets.
- Ensure timely entry and update of clinical trial information in tracking systems.
- Perform quality checks on study documentation to ensure compliance and accuracy.
- Support audit and inspection readiness activities.
Regulatory and Start up Specialist 2
IQVIA
Ahmedabad
08.2011 - 08.2015
- Acted as SPOC in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Handled the review, preparation, and negotiation of contractual agreements and budget plans.
- Ensured meticulous completion and upkeep of tracking tools, internal systems, and databases for project-related data.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Communicated completion status of regulatory and contractual documents to team members.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
- Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
- Perform quality control of documents provided by sites.
- Have direct contact with sponsors on specific initiatives.
- Executed site selection assessments with professional training.
- Engaged in feasibility assessments and location identification.
Education
Bachelor of Pharmacy - Pharmacy
Nootan Pharmacy College
AhmedabadSkills
- Clinical trial management
- Authorizing of dossiers
- Global Clinical Trial (CTA) Dossier Submission/Approval
- Audits and/or regulatory inspection
- Labeling Development
- Liaising with customers and/or external vendors
- Query resolution
- Regulatory compliance
- Data management
- Clinical documentation
- Case report form tracking
- Site coordination
- Invoice processing
- Audit readiness
Certification
- Barnett Accreditation - Fundamentals GCP EXAM for support staff, 2012
- Expert GCP Accreditation Exam(For managers and staff interacting with investigational sites), 2016
Certifications
01-2012
Personal Information
Title:Clinical Trial Assistant
Regulatory And Start Up Specialist 2
Timeline
Clinical Trial Assistant
IQVIA
08.2015 - 11.2023
Regulatory and Start up Specialist 2
IQVIA
08.2011 - 08.2015
Bachelor of Pharmacy - Pharmacy
Nootan Pharmacy College
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