Clinical Research Associate at Apex Asia Pacific Private Limited (2023-07 – 2025-07)
- Perform site qualification visits, Clinical Trial Application compilation and submission in the portal, EC dossier preparation and submission.
- Site selection and qualification.
- Site Initiation and site monitoring visit for subject safety.
- Meet with Clinical Investigators and staff before study initiation to ensure all aspects of the study are understood by the investigator and staff, if required train the study team.
- To manage eTMF/TMF documents for the studies & review the quality and the indexing of documents submitted to the TMF/eTMF, TMF management processes and the use of the Electronic Trial Master File (eTMF) system.
- Ensures EC dossier submission at sites, approval, and site initiation visit.
- Following with sites for CRF data entry, query status & query resolution in EDC platform, and SAEs form filling.
- Monitor study progress to ensure compliance with protocol requirements, applicable regulations, guidelines, and Good Clinical Practices.
- Monitor and track patient enrollment and study progress.
- Perform site monitoring visit / remote monitoring visit to include a review of the source document, case report form, ICD, Patient Diary, Investigator Site Binder, CTM & NCTM accountability, and other documents as applicable.
- Prepare the site for possible Internal and/or Client Audits / Inspections.
- Archival with an Inventory list of Source documents/ CRFs/ CTM/ Others at site.
- Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution.
- Review the Site Invoice as per CTA & follow-up site payment status.
Trial Master File Specialist (Level – II), Clinical Trail Document Management at ICON Clinical Research (2022-07 – 2023-07)
- Uploading documents and initiating workflow in sponsor eTMF.
- Performing Quality checksfor e-documents and paper documents.
- Performing analysis activity with regard to the Timelines, Completeness and quality of eTMF.
- Follow processesforset up, Maintenance, and support for assigned TMF projects.
- Familiar with Veeva Vault.
- Country/Site level document collection from site/CRA/ CTA &Document& email upload.
- Reconciliation of TMF documentation related to study specific audits.
Clinical Research Associate at Apex Asia Pacific Private Limited (CRO-SRMC) (2018-06 – 2021-04)
- Perform site qualification visits, Clinical Trial Application compilation and submission in the portal, EC dossier preparation and submission.
- Site selection and qualification.
- Site Initiation and site monitoring visit for subject safety.
- Meet with Clinical Investigators and staff before study initiation to ensure all aspects of the study are understood by the investigator and staff, if required train the study site team.
- Ensures EC dossier submission at sites, approval, and site initiation visit (Remote / Onsite).
- Ensuring targeted recruitment.
- Following with sites for CRF data entry, query status & query resolution in EDC platform, and SAEs form filling.
- Monitor study progress to ensure compliance with protocol requirements, applicable regulations, guidelines, and Good Clinical Practices.
- Monitor and track patient enrolment and study progress.
- To manage eTMF/TMF documents for the studies & review the quality and the indexing of documents submitted to the TMF/eTMF, TMF management processes and the use of the Electronic Trial Master File (eTMF) system.
- Ensures EC dossier submission at sites, approval, and site initiation visit.
- Monitor and track patient enrollment and study progress.
- Perform site monitoring visit / remote monitoring visit to include a review of the source document, case report form, ICD, Patient Diary, Investigator Site Binder, CTM & NCTM accountability, and other documents as applicable.
- Prepare the site for possible Internal and/or Client Audits / Inspections.
- Archival with an Inventory list of Source documents/ CRFs/ CTM/ Others at site.
- Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution.
- Review the Site Invoice as per CTA & follow-up site payment status.
- Oversees all aspects of study site management to ensure high quality data resulting in consistently low query and in good Quality Assurance reports.
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Communicates effectively with site personnel, including the principal investigator (PI), and medical Head to relay protocol/study deviations and ensure timely implementation of corrective actions.
- Maintains Study tracking, in accordance with the demands of the study.
- Understands and updates Clinical Trials site details in server.
Senior Clinical Research Coordinator, Clinical Research Division at Central Research Facility (CRF), Sri Ramachandra University (2015-06 – 2018-06)
- Coordinating with Investigators from Feasibility till End of Study. EC dossier submission.
- Attending EC meetings.
- Maintaining Site Master File (ISF).
- Resolving Queries (EC/CRO/Sponsor/Regulatory bodies).
- End-to-End Data Entry.
- Scheduling subject visits.
- IP management (Randomization/Kit Dispense) & accountability.
- Delegating activities to the coordinators.
- Overseeing activities of Junior Coordinators.
- Notification of Periodic reports (including Study status/ Deviations/ Adverse Events (SAE)).
- Attending meetings and conferences as and when required.
Clinical Research Coordinator, Clinical Research Division at Central Research Facility (CRF), Sri Ramachandra University (2013-10 – 2015-05)
- Assiststhe Principal Investigator during study feasibility assessments asrequested.
- Collecting documents needed to initiate the study and submit to the Sponsor. e.g., FDA.
- Forms 1572, CVs, Local Lab Reference Ranges, EC-SOPs etc.).
- Obtaining approval from Ethical Committee/ Regulatory bodies.
- Maintaining and periodic updating of Site Master File.
- Screen subjects for eligibility using protocol specific inclusion and exclusion criteria's, documenting each potential participant's eligibilities or exclusions.
- Randomization of patients through Interactive Voice Response System (IVRS).
- IWRS (Interactive Web Response System). End-To-End Data entry process.
- Capturing all relevant data in Clinical Databases.
- Scheduling subject visits and Follow-Up according to protocol. Instant Alerting PI/Sub I of any abnormal test results.
- Perform site monitoring visit / remote monitoring visit to include a review of the source document, case report form, ICD, Patient Diary, Investigator Site Binder, CTM & NCTM accountability, and other documents as applicable.
- Prepare the site for possible Internal and/or Client Audits / Inspections.
- Archival with an Inventory list of Source documents/ CRFs/ CTM/ Others at site.
- Review the Site Invoice as per CTA & follow-up site payment status.
- Oversees all aspects of study site management to ensure high quality data resulting in consistently low query and in good Quality Assurance reports.
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Communicates effectively with site personnel, including the principal investigator (PI), and medical Head to relay protocol/study deviations and ensure timely implementation of corrective actions.
- Maintains Study tracking, in accordance with the demands of the study.
- Understands and updates Clinical Trials site details in server.
- Reporting Serious Adverse Events to the Sponsor and the Ethics Committee as per applicable guidelines.
- Reports safety letters and other study relevant documents to Ethics Committee as a notification in a timely manner.
- Having good knowledge in capturing Adverse Events(AE's) and Concomitant medications (CONMEDS) to eCRF from the source document. Sound knowledge in Oracle Clinical Remote Data Capture.
Inservice Educator, Ward & Operation Theatre at Sri Ramachandra Medical Centre (2010-06 – 2013-10)
- To increase the existing knowledge base of nurse practicing clinical nursing.
- To improve and maintain high standard of nursing care to patients which would increase the satisfaction level of patients / relatives.
- To improve communication skills among nursing personnel.
- Planning, Designing, Implementing and evaluating all educational activities for nursing staff including provision of educational services.
Nurse, Ward & Operation Theatre at Sri Ramachandra Medical Centre (2004-12 – 2008-05)
- Communicating with doctors, patients, other department and co-workers about patientcare, locating and sharing resources and organizing of patient care.
- Patientcare, locating and sharing resources and organizing of patient care.
- Administering medications (IV, IM, SC, ID).
- Promoted health care for patients and their families, dissemination of information to support groups.
- Establishing treatment plans, operating medical equipment Trained Nursing Students.
