Intern - Osler Research Institute for Health Innovation - Brampton, Canada
(2026-03)
- Prepared and submitted ethics applications through the electronic Research Ethics Board (eREB) system for clinical studies
- Served as the primary liaison between clinical sites, research institutions, and cross-functional teams to resolve regulatory and operational queries
- Reviewed site regulatory documents and responded to REB queries to ensure compliance with regulatory and ethics requirements
- Collaborated with academic institutions, investigators, and research sites to resolve scientific, clinical, and regulatory inquiries
- Coordinated regulatory, ethics, informed consent, and site approval documentation to support timely site activation
- Maintained regulatory tracking systems, monitored project timelines, and conducted quality reviews of study documentation
- Assisted in preparing donor lists and background research to support grant applications and funding proposals
- Drafted and refined professional bios for Osler Research investigators to support grant submissions and institutional profiles
- Completed Tri‑Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) training with official certification
- Completed Good Clinical Practice (GCP) training, ensuring compliance with international clinical research standards
Proposals and Contracts Associate - BioPharma Services Inc. - Toronto, Canada
(2025-10 - 2026-01)
- Reviewed BA/BE and Phase 1 study synopses to ensure scientific rigor and alignment with RFP scope; flagged assumptions and protocol risks early to reduce rework
- Translated RFP requirements into actionable proposal outlines, timelines, and input requests; consolidated contributions from PK/PD and Clinical Operations to produce cohesive study designs
- Built bottoms‑up study budgets (person‑hours, pass‑throughs, third‑party costs) and validated pricing scenarios against scope and operational feasibility
- Partnered with Finance to define and track billing milestones; maintained invoice readiness and supported revenue recognition for awarded studies
- Owned trackers, Salesforce and Smartsheet's for opportunity status, deliverables, and dependencies; published cadence reports and drove on‑time proposal submissions
- Coordinated pre‑award contract activities (CDA/MSA/SOW) with Contracts teams, ensuring consistency between scope, budget, and terms
- Facilitated internal strategy calls; captured decisions, risks, and action items; followed through to closure to maintain bid velocity
- Contributed to continuous improvement by standardizing templates/checklists and documenting lessons learned to shorten cycle times
Safety and Warehouse Associate - Amazon Fulfillment Centre - Brampton, Canada
(2020-05 - 2025-10)
- Ensured compliance with workplace safety standards and operational procedures within a high‑volume fulfillment environment
- Identified safety risks and supported corrective actions, contributing to incident reduction and regulatory compliance
Sr. Clinical Process Associate - IQVIA - India
(2015-11 - 2017-06)
- Performed complex study‑related processes to ensure timely, high‑quality deliverables aligned with SLAs and project timelines
- Conducted periodic reviews of site management activities, identifying risks and recommending corrective actions
- Ensured protocol adherence, regulatory compliance, and integrity of site practices
- Established and maintained effective communication with internal and external stakeholders
- Created and maintained study‑specific documentation and internal tracking systems
- Collaborated with project leads and team members on study document development and review
- Oversaw compliance with CTMS, IVRS/IWRS, and eTMF requirements
- Managed the study mailbox and delegated tasks as needed
- Generated distributed and followed up on project reports
Clinical Research Associate - Consortium Clinical Research - Hyderabad, India
(2013-03 - 2015-10)
- Performed feasibility studies as requested
- Conducted and implemented pre-study/start-up activities and site activation visits as per assigned projects, in compliance with ICH-GCP and internal SOPs
- Prepared informed consent forms, site initiation, ongoing monitoring reports, and submission-related documents for IRB/IEC approval
- Ensured completeness, accuracy, and submission of regulatory documents to Ethics Committees and local regulatory authorities, including IRB/IEC approval, informed consent forms, and lab certifications
- Identified errors at study start-up visits and made continuous improvements in site visit reports
- Coordinated with Clinical Study Managers (CSMs) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethical requirements, track and drive site activations, and manage submissions on trial amendments
- Assessed, monitored, and mentored study site staff for protocol adherence, as required
- Conducted monitoring including Source Document Verification (SDV) and site file maintenance
- Maintained ISF (Investigator Site File)
- Reported adverse events and serious adverse events to Ethics Committees, Sponsors, and local regulatory authorities, in compliance with regulatory requirements
- Prepared concise reports of monitoring visits in accordance with local regulatory requirements
- Updated knowledge of related regulatory requirements and ensured compliance with local regulations and internal procedures
- Reviewed eTMF to ensure compliance with local requirements
Clinical Research Associate - Lauren Clinical Research - India
(2011-05 - 2013-03)
- Completed therapeutics, protocol, and clinical research training to effectively perform job duties
- Gained experience in study procedures by collaborating with experienced clinical staff
- Performed site selection, initiation, monitoring, and close-out visits under supervision, adhering to the contracted scope of work and good clinical practices
- Developed project subject recruitment plans on a site basis, if applicable
- Provided protocol and study-related training to assigned sites, establishing regular communication to manage project expectations and issues
- Evaluated the quality and integrity of study site practices under supervision, ensuring proper conduct of the protocol and adherence to applicable regulations, and escalated quality issues as needed
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution
- Supported the start-up phase under supervision
- Created and maintained documentation regarding site management, monitoring visit findings, and action plans, including submitting regular visit reports and generating follow-up letters
- Communicated study features and opportunities to sites
- Collaborated with study team members to support project execution
Travel Agent - Tirumala Travel Agency - Nandyal, India
(2017-07 - 2020-02)
- Arranged itineraries, bookings, and timing for employees or customers
- Coordinated flights, cars, hotels, resolve delays or cancellations with airlines and rental companies
- Maintain booking records, invoices, confirmations, and travel policies in booking systems or Excel
