Jeeva Subramani

Seeking a position so as to utilize my skills, abilities, and potentials in pharmacology and clinical research field, that will offer mean opportunity for professional growth while being resourceful and innovative. Competent and hardworking professional with qualitative knowledge in the field, accented with the latest trends and techniques of the field. Equipped with the knowledge of subject-line related to Pharmacology, with inherent interest in working in the field of clinical research.

Good understanding of all the ethical guidelines in clinical research, regulations in clinical research, clinical trial documentation and clinical trial management. Developing professional, with high Caliber, work orientation and ability to handle multiple functions and activities in a high-pressure environment due to inherent ability to identify and prioritize tasks at hand. Focused with immaculate work habits, learning aptitude, time management and team working spirit with balanced emotional and social quotient.

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.

Certificate in Clinical Research & Clinical Data Management – Aldos Institute of Health & Medical Science (2011 – 2011)

B.Sc. in Nursing – Sri Ramachandra University (2010 – 2010)

Diploma in Nursing – Kumaran Hospital (2004 – 2004)