Clinical Research Trial

Professional Summary

Accomplished Physician Assistant with expertise in clinical research, pharmacovigilance, and advanced statistical methodologies.

Proficient in orchestrating clinical trials and managing regulatory submissions to enhance pharmaceutical product safety and efficacy.

Skilled in conducting complex clinical trials with strict adherence to GCP guidelines and SOPs.

Experienced in using Clinical Trial Management Systems (CTMS) for efficient patient recruitment, site activation, and data oversight.

Expertise in MedDRA coding, adverse event reporting, and maintaining regulatory compliance across global standards.

Proficient in developing and implementing SOPs aligned with FDA, EMA, and OHRP regulations.

Strong background in analyzing and interpreting multi-source clinical trial data for informed decision-making.

Skilled in data validation, report generation, and ensuring data integrity throughout clinical studies.

Proficient in managing clinical documentation with a focus on regulatory readiness and data integrity.

Experienced in electronic Trial Master File (eTMF) systems and Electronic Health Record (EHR) management.

Specialized in risk-benefit analysis, adverse event monitoring, and proactive risk mitigation strategies.

Knowledgeable in pharmacokinetics, dose-response analysis, and protocol-driven medication administration.

Proven success in supporting regulatory inspections and audits through thorough documentation and compliance.

Demonstrated expertise in ICH-GCP standards and local regulatory requirements in clinical research settings.

Skills

Clinical Trial Management Systems (CTMS) Proficiency – Experienced in using platforms like Medidata, Oracle InForm, and Veeva Vault to manage study workflows.

Good Clinical Practice (GCP) Compliance – Ensures all clinical activities adhere to ICH-GCP, FDA, and EMA standards.

Protocol Development and Implementation – Skilled in drafting, reviewing, and executing clinical protocols across multiple phases (I–IV).

Electronic Data Capture (EDC) ystems – Hands-on experience with systems like Rave, REDCap, and eCRF platforms.

Site Monitoring and Management – Conducted pre-study, initiation, monitoring, and close-out visits for 10+ sites.

Patient Recruitment & Retention – Developed strategies that improved enrollment rates and reduced dropout by 20–30%.

Risk-Based Monitoring (RBM) – Applied RBM techniques to optimize resources and identify high-risk data trends.

Clinical Documentation & eTMF Management – Maintained audit-ready documentation throughout the trial lifecycle.

Training & SOP Development – Developed and delivered 15+ training sessions and created study-specific SOPs.

Applied ICD-10 codes to patient records to ensure compliance with billing, regulatory, and reporting standards.

Professional Experience

Healthcare Data Analyst - FL Tech Solutions, Tampa, Florida (July 2024 – Present) (Remote)

Developed and implemented predictive models to forecast patient outcomes, enabling healthcare providers to make proactive decisions and improve patient care.

Led the design and implementation of a centralized data warehouse, ensuring seamless data integration across multiple healthcare systems for a unified view of operations.

Optimized healthcare resource allocation by analyzing data trends in patient volume and service utilization, helping reduce waiting times and improving service delivery.

Collaborated with IT and data engineering teams to enhance data collection methodologies, improving data accuracy and consistency across all systems.

Provided actionable insights to senior management by analyzing patient demographics, treatment efficacy, and operational metrics, contributing to informed business strategies.

Developed automated data pipelines, reducing manual data entry and improving data processing efficiency by 30%.

Created dynamic reports for healthcare stakeholders, offering real-time access to critical performance metrics and operational KPIs.

Led cross-departmental meetings to ensure data-driven decision-making and alignment between data analytics teams and clinical operations.

Supported regulatory compliance efforts by auditing data sources and ensuring adherence to HIPAA, FDA, and other healthcare regulations.

Trained clinical and administrative teams on the effective use of data visualization tools, empowering them to leverage analytics in their daily workflows.

Enhanced patient care processes by identifying gaps in care delivery through data analysis, resulting in a 10% improvement in treatment outcomes.

Monitored healthcare KPIs such as patient satisfaction, readmission rates, and treatment effectiveness, using insights to continuously improve operational and clinical practices.

Collaborated with external healthcare partners to ensure accurate data sharing and alignment with industry best practices for data management.

Clinical Physician Assistant

Southern Gem Hospital, Hyderabad, INDIA (June 2019- July 2023)

Conduct thorough clinical assessments of patients upon admission, accurately diagnosing conditions and determining appropriate treatment plans.

Provide immediate medical care and interventions, including administering medications, treatments, and procedures in both emergency and routine scenarios.

Monitor patient progress, adjust treatment protocols as necessary, and ensure timely follow-up care.

Respond swiftly to medical emergencies, prioritizing critical cases and implementing life-saving measures to stabilize patients.

Coordinate with emergency response teams to manage acute medical situations, including trauma, cardiac arrests, and other critical conditions.

Maintain readiness to handle a high volume of patients during peak times, ensuring efficient triage and care delivery.

Collaborate with physicians, nurses, and other healthcare professionals to provide coordinated and comprehensive patient care.

Accurately document patient histories, examination findings, diagnoses, treatments, and outcomes in medical records.

Provide patient education on treatment plans, medication usage, lifestyle modifications, and preventive health practices.

Clinical Physician Assistant

Dr. Kalyan’s Hospital, Hyderabad, INDIA (March 2019- June 2019)

Conduct thorough clinical assessments of patients upon admission, accurately diagnosing conditions and determining appropriate treatment plans.

Directed and managed clinical research protocols, ensuring rigorous adherence to standard operating procedures (SOPs) and regulatory requirements.

Utilized Clinical Trial Management Systems (CTMS) to enhance patient recruitment, streamline site initiation, and optimize data collection processes, significantly improving trial efficiency.

Played a pivotal role in pharmaceutical safety, with a focus on adverse drug reaction (ADR) reporting and MedDRA management, contributing to the overall integrity and safety of clinical trials.

Developed and implemented SOPs aligned with FDA and OHRP regulations, ensuring compliance and consistency across all clinical research activities.

Clinical Research Intern

S.C.S.E.S’s Shree Shiv Basav Jyothi Homeopathic Medical College-Internship (April 2018- March 2019)

Played a pivotal role in coordinating and managing clinical trials, ensuring rigorous adherence to study protocols and GCP standards.

It effectively supported patient recruitment and retention strategies, contributing to the successful enrolment of study participants.

Managed data collection processes precisely, ensuring data integrity and consistency across all study phases.

Contributed to quality assurance initiatives by meticulously monitoring trial progress, identifying potential issues, and ensuring compliance with regulatory and ethical guidelines.

Collaborated with multidisciplinary teams to optimize clinical workflows and enhance trial efficiency, resulting in timely and accurate data submissions.

Education

Master’s in healthcare administration (Aug 2023- May 2025)

Indiana Wesleyan University, Marion, IN

Bachelor’s Degree in Homeopathic Medicine and Surgery (Sept 2013- April 2018)

Shree Shiv Basav Jyothi

Graduated with Honours

Certifications

Registered Homeopath physician - Board of Indian Medicine - Govt. of Telangana

CPR/AED/First-Aid Certified

HIPAA Certification – Health Insurance Portability and Accountability Act Compliance

Certificate of Merit- First Rank in ANATOMY in First Year of BHMS Honored with Gold Medal.

Thesis

Title: “Advancements and Challenges in Gynecology: A Comprehensive Study of Women’s Reproductive Health” at AADHAR HOSPITAL, KARNATAKA, INDIA

Technical Skills

Clinical Research and Trial Management: GCP, CTMS, protocol development, site management, patient recruitment.

Pharmacovigilance and Safety Compliance: MedDRA, adverse event reporting, safety signal detection, FDA/EMA regulatory compliance.

Data Analysis and Reporting: Microsoft Excel, data validation, report generation, data visualization.

Clinical Documentation and EHR Systems: eTMF management, EHR systems, clinical documentation, regulatory submissions.

Patient Safety and Risk Assessment: Risk-benefit analysis, pharmacokinetics, dose-response analysis, adverse event monitoring, and mitigation strategies.

Regulatory Inspections and Audits: Clinical data management, audit readiness, regulatory compliance, ICH-GCP.

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