Anilgundepogula G

Clinical Research Professional with 7+ years of experience across Clinical Research Associate (CRA) and Senior Clinical Process Associate roles, supporting Phase I–IV clinical trials in Oncology, Diabetes, and Respiratory therapeutic areas. Strong expertise in site monitoring, regulatory compliance, GCP/ICH‑E6, and clinical trial operations. Proven record of monitoring 100+ site visits, ensuring 100% audit readiness, data integrity, and adherence to global regulatory requirements.

Adept at cross‑functional collaboration, risk identification, and process optimization to drive study milestones on time and within scope.

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

Certification - Clinical Research Associate Certification Program - Udemy

Clinical Research Program - Clinical Research - Oxford College (2026)

Master's - Pharmacology - Sri Krishnadevaraya University (2011)

Bachelor - Pharmacy - Jawaharlal Nehru University (2007)