Clinical Research Trial

Professional Summary

•Experienced healthcare professional dedicated to clinical research, adverse drug reporting, and statistical analysis. Proficient in utilizing industry-standard tools and processes to ensure pharmaceutical product safety and efficacy while extracting meaningful insights from clinical data.

•Managing study protocols, ensuring compliance with standard operating procedures, and overseeing clinical trials with meticulous attention to detail.

•Expert in MedDRA (Medical Dictionary for Regulatory Activities), CTMS (Clinical Trial Management Systems), clinical documentation, and SAS programming. Skilled in maintaining and updating MedDRA dictionaries to meet evolving regulatory requirements, fostering compliance across cross-functional teams.

•Accomplished in managing Clinical Trial Management Systems (CTMS) to optimize trial operations, covering patient recruitment, site initiation, and data collection.

•Leverages CTMS data for protocol compliance, site performance analysis, and efficient resource allocation.

•Hands-on experience in utilizing Power BI to integrate and analyze diverse datasets from clinical trials, ensuring comprehensive insights into study progress, patient outcomes, and protocol compliance.

•Developed comprehensive Standard Operating Procedures (SOPs) in compliance with FDA and OHRP regulations, ensuring adherence to all operational requirements.

•Proficient in managing comprehensive clinical documentation throughout the trial lifecycle, ensuring data integrity, accessibility, and compliance.

•Ensures a secure, organized trial master file (eTMF) to support regulatory inspections and audits while facilitating case report form (CRF) creation and data quality maintenance.

•Demonstrated expertise in data analysis, informatics solutions, and electronic health record (EHR) systems, including proficiency in Epic.

•SAS programming expert for statistical analysis, encompassing safety and efficacy outcomes.

•Validates data, creates data visualizations, and generates detailed statistical reports to drive data-driven decision-making.

•Actively participates in regulatory inspections and audits, showcasing expertise in clinical data management and documentation.

•Prioritizes patient safety through proactive risk identification, evaluation, and mitigation for investigational products. Monitors and assesses the impact of adverse events on patient well-being and overall trial outcomes.

•Accurately calculates pharmaceutical dosages, concentration dilutions, and infusion rates with precision, guaranteeing that medications are administered precisely and that specified protocols are followed.

•Dedicated to upholding the highest standards of compliance, data quality, and statistical analysis while placing patient safety at the forefront of clinical trial management efforts.

Skills

FDA Regulations:

GCP, GMP, HIPAA

Data Management

Medidata Rave, REDcap, CTMS, EHR, EPIC, eTMF, CRF, eCRF

Adverse Event Reporting System

MedDRA, CTCAE, Oracle AERS, Argus Safety

Software

Documentum, Share Point, SAS Data Integration Studio, Power BI

Operating Systems

Microsoft Windows, Mac, and UNIX

Other Tools:

MS Office Suite, MS Project

Work History

Senior Clinical Research Coordinator (05/2024 — CurrenCLIANTHIS CLINICAL RESEARCH

Responsibilities:

•Effectively engaged with oncology patients, communicating intricate details about research studies, addressing inquiries, and ensuring the acquisition of informed consent.

•Regularly interfaced with current and potential clinical trial participants, ensuring alignment with protocol, and determining eligibility through effective communication and consent processes.

•Developed comprehensive Standard Operating Procedures (SOPs) in compliance with FDA and OHRP regulations, ensuring adherence to all operational requirements.

•Functioned as the primary point of contact for participants, maintaining regular communication on study progress, facilitating team involvement, and promptly notifying the Principal Investigator of safety events.

•Lead and inspire a multidisciplinary team, fostering a positive and productive work environment. Facilitate seamless study coordination, patient enrollment, and effective communication across team members to achieve optimal research outcomes.

•Managed participants visit scheduling, technical troubleshooting, and maintained study supplies, demonstrating a proactive approach to issue resolution and escalation when needed.

•Demonstrate advanced proficiency in phlebotomy techniques, optimizing the collection and processing of patient blood samples across multiple phases of clinical trials, ensuring data accuracy and integrity.

•Ensure rigorous adherence to study protocols, meticulously overseeing the completion of all source documents. Maintain accurate and comprehensive records to ensure strict compliance with regulatory standards, including HIPAA rules.

•Proactively identify and resolve queries generated by investigators, collaborating closely with principal investigators to address concerns. Uphold the integrity of research data across various clinical trial phases.

•Conducted detailed reviews of medical records and screenings to identify eligible study participants, performing interviews and quality-of-life questionnaires, with data capture facilitated through electronic data capture (EDC) systems.

•Using Power BI to combine and examine various clinical trial datasets, guaranteeing thorough understanding of research development, patient results, and protocol adherence.

•Ensured accurate and timely data collection, documentation, entry, and reporting in both Sponsor and organization databases.

•Utilize sophisticated Electronic Data Capture (EDC) systems, including Flatiron and CRIO software, to streamline data management processes.

•Enhance overall study efficiency through effective utilization of technology.

•Diligently apply inclusion and exclusion criteria outlined in study protocols, facilitating the precise selection of eligible patients for enrollment across different clinical trial phases.

•Successfully manage multiple tasks concurrently, exhibiting a steadfast commitment to efficiency and productivity. Consistently complete all responsibilities ahead of deadlines across diverse phases of clinical research.

•Maintained regular contact with the Principal Investigator and team, providing comprehensive reviews of study details, progress, adverse events, and enrollment status.

•Demonstrate comprehensive knowledge and experience across all phases of clinical research, from initial planning and recruitment (Phase I) through to large-scale trials (Phase III) and post-marketing surveillance (Phase IV).

•Accountable for site compliance with subject safety reporting, escalating issues as necessary to uphold the highest standards of safety and regulatory compliance.

Clinical Research Specialist (01/2019— 06/2022)

Aseel Hospital – Sanga Reddy, Hyderabad, IND

Responsibilities:

•Actively engaged with Epic Systems, a leading Electronic Health Record (EHR) platform, including data entry, retrieval, and system customization, to support efficient healthcare data management and accessibility. Proficiently navigated Epic's modules, optimizing its functionalities to enhance patient care.

•Utilized Epic-generated data for in-depth clinical analysis, extracting actionable insights to guide clinical decision-making and quality improvement initiatives. Analyzed patient data, clinical outcomes, and treatment protocols within Epic, contributing to evidence-based patient care.

•Collaborated closely with clinical teams to identify areas for workflow improvement, leveraging informatics solutions within Epic to enhance efficiency and patient care. Assisted in the development and implementation of clinical pathways, order sets, and alerts to streamline care processes.

•Prepared detailed documentation of informatics processes and procedures, contributing to the development of best practices and standard operating protocols. Created user-friendly guides for healthcare professionals to maximize their effectiveness in utilizing Epic EHR.

•Worked closely with healthcare professionals from diverse backgrounds, fostering effective communication and teamwork to achieve informatics objectives. Collaborated with physicians, nurses, and administrative staff to ensure smooth integration of informatics solutions into clinical workflows.

•Contributed to quality improvement projects by analyzing data from Epic EHR, identifying trends, and recommending evidence-based interventions to enhance patient outcomes and reduce clinical variations.

•Received comprehensive training on informatics tools and Epic EHR system functionalities, ensuring seamless adoption and utilization among staff. Participated in training sessions and provided support to colleagues during their transition to EHR-based practices.

•Proves a good ability to perform pharmacological calculations, including estimates of doses depending on patient data, drug concentrations, and infusion rates. Ensuring the safety and effectiveness of pharmaceutical interventions in clinical research settings requires a thorough use of mathematical principles.

•Engaged in research projects related to healthcare informatics, examining emerging trends and technologies to support data-driven healthcare practices. Evaluated innovative informatics solutions and their potential impact on patient care and clinical outcomes.

•Leveraged Epic's telehealth capabilities to provide remote patient care, enhancing accessibility and patient engagement during the ongoing shift toward telemedicine. Conducted virtual patient visits, recorded data, and communicated treatment plans through the Epic platform.

Clinical Research Coordinator (10/2016 — 08/2018)

Nims Hospital – Hyderabad, India

Responsibilities:

Coordinated administrative tasks essential for carrying out clinical trials, guaranteeing a smooth workflow and adherence to research protocols, while leveraging tools such as MedDRA (Medical Dictionary for Regulatory Activities) for accurate coding of adverse events.

Expertly maintained comprehensive research data, including the creation and completion of source documents/case report forms, as well as precise data entry, utilizing Clinical Trial Management Systems (CTMS) for streamlined data management and trial tracking.

Assisted in patient/participant recruitment by creating and implementing standardized procedures, contributing to the success of recruitment efforts while leveraging CTMS tools to monitor recruitment metrics and progress.

Actively participated in study meetings, including scheduling and attendance, to foster collaboration and alignment among research teams, often employing digital collaboration and communication tools to facilitate remote collaboration.

Ensured strict adherence to research protocols, meticulously reviewing case report forms, and conducting audits to maintain data accuracy.

Managed equipment and supplies, ensuring their availability and functionality throughout the course of the trials, while also utilizing inventory management software for efficient tracking and procurement.

Conducted detailed reviews of medical records and screenings to identify eligible study participants, performing interviews and quality-of-life questionnaires, with data capture facilitated through electronic data capture (EDC) systems.

Collected study specimens in strict accordance with protocols, including blood processing and preparation for shipping, ensuring precise specimen handling, and data tracking through EDC systems.

Ensured strict adherence to research protocols, meticulously reviewing case report forms, and conducting audits to maintain data accuracy, with regular cross-referencing with MedDRA terminology.

Assisted in the development of recruitment strategies and actively engaged in participant screenings, including interviews and questionnaires, optimizing recruitment procedures using CTMS tools.

Contributed to the creation of standard operating procedures (SOPs) and standard works, streamlining research processes for improved efficiency, while implementing CTMS for protocol management and workflow optimization.

Acted as the lead study coordinator for multiple clinical trials spanning Phase 1 to 3, managing a participant cohort exceeding 30 individuals and overseeing their data capture, adverse event reporting using MedDRA, and overall trial progress.

Collected data meticulously, adhering to research protocols, operations manuals, and case report form requirements, ensuring data integrity and completeness through EDC systems and CTMS tools.

Clinical Pharmacy Services(10/2014— 10/2016)

MYTHRI HOSPITAL– Hyderabad, India

Responsibilities:

Collaborated with the research team to collect, clean, and preprocess clinical data, ensuring data integrity and reliability for subsequent analysis. Employed Electronic Data Capture (EDC) systems to streamline data collection and adherence to data standards.

Utilized advanced statistical software, including SAS, to perform data analysis, validate data quality, and create clear and insightful graphical representations of clinical data trends. These visualizations aided in the interpretation and presentation of research findings, facilitating data-driven decision-making.

Worked closely with network administrators to maintain a robust and secure network infrastructure for seamless data transmission between laboratories and research teams.

Ensured data encryption and adherence to data privacy regulations (e.g., HIPAA or GDPR).

Managed server configurations to guarantee optimal data storage, security, and accessibility for research and clinical data, including Electronic Health Records (EHR) systems, leveraging cloud-based storage solutions where applicable.

Successfully implemented middleware solutions to integrate laboratory instruments with the Laboratory Information System (LIS), improving data flow, reducing manual data entry errors, and enhancing data accuracy.

Conducted statistical analyses on clinical data sets, including descriptive statistics, hypothesis testing, regression analysis, and survival analysis. These analyses contributed significantly to the research objectives and publications, enabling the identification of trends and associations in the data.

Collaborated effectively with cross-functional teams, including researchers, clinicians, and statisticians, to understand project objectives, contribute to data analysis strategies, and provide expert insights on data interpretation.

Prepared comprehensive reports and summaries of data analysis results, assisting in decision-making processes and research documentation. These reports were critical in communicating findings to stakeholders, regulatory bodies, and research partners.

Actively participated in continuing education and training programs to stay updated on the latest advancements in data analysis, clinical research methodologies, and regulatory requirements, further enhancing the quality and impact of research initiatives.

Medical Reviewer Intern PART TIME (09/2014— 10/2015)

Afshan QTAT – Hyderabad, India

Responsibilities:

Conducted meticulous and in-depth reviews of patient medical records, scrutinizing surgery related information and device installations to identify any anomalies, complications, or deviations from expected outcomes.

Proficiently identified and documented any irregularities, adverse events, or surgical complications, ensuring accurate and comprehensive case documentation.

Demonstrated a strong commitment to adhering to all relevant healthcare regulations, ethical standards, and best practices in medical record review.

Advocated for the well-being and rights of patients by contributing to the resolution of surgical complications and device-related problems through the legal system.

Maintained accurate and organized records of case reviews, ensuring the timely submission of reports and complaints to support legal proceedings.

Education

MS Health Informatics, NEW ENGLAND COLLEGE-Henniker, New Hampshire. USA

Pharm D (Doctor of Pharmacy), JNTUNIVERSITY-Hyderabad, Telangana, India)

Certifications:

Base SAS Global Certification

Registered Pharmacist

GCP

ICH

Data Programming knowledge.

SAS

References:

1.Dr Abdul Mannan .-AVICENA CLINICAL

*****.******.********@****************.***

2.Prof.Ach Jennifer

Department of Legal compliance in Health care.

*****.****@***.***

3.Dr. Sree Bhushan Raju

Prof &Head of Department of Nephrology Clinical Trials Unit II

Nims -Hospital -Hyd

Contact no:+919*********

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