Patient Safety Data Integrity

UNITED STATES, • **********@*****.*** • 347-***-****

AJAY REDDY

CRA

PROFESSIONAL SUMMARY

CRA with over 4 years of extensive expertise in clinical monitoring and trial management, specializing in GCP compliance and protocol adherence. Demonstrates proficiency in data verification, site efficiency, and patient safety, fostering team growth and optimizing trial processes. Passionate about advancing clinical trials through strategic insights and innovative approaches, committed to maintaining data integrity and enhancing study outcomes.

EMPLOYMENT HISTORY

SR. CLINICAL RESEARCH ASSOCIATE (CONTRACTOR)Apr 2022 - May 2024

Lab CorpSan Jose

Oversee oncology trials ensuring compliance and data integrity, boosting study outcomes.

Enhance trial efficiency by streamlining site processes, leading to measurable improvements.

Train new associates, fostering team growth and collaboration.

Collaborate with data management to optimize data handling, ensuring patient safety.

Achieve significant improvements in patient safety and study outcomes.

Spearheaded oncology clinical trials, ensuring rigorous compliance and data integrity. Streamlined site processes, boosting overall trial efficiency.

Optimised data handling procedures in partnership with data management team, significantly enhancing study outcomes and patient safety.

Cultivated team growth by mentoring new associates, fostering a culture of continuous learning and professional development.

Pioneered novel approaches to site qualification and closure, markedly improving trial timelines and resource allocation.

Meticulously oversaw all aspects of clinical trials, from protocol adherence to data quality, ensuring the highest standards of research integrity.

Optimised oncology trial processes, enhancing data integrity and compliance. Implemented efficient site procedures, resulting in measurable improvements to study timelines.

Developed novel approaches to site qualification and closure, markedly enhancing resource allocation and trial efficiency across oncology studies.

Drove substantial improvements in patient safety and study outcomes through meticulous oversight of trial protocols and data quality assurance measures.

Spearheaded initiatives to streamline clinical research processes, fostering a culture of continuous improvement and excellence in oncology trials.

Optimised oncology trial processes, enhancing data integrity and compliance. Implemented efficient site procedures, resulting in measurable improvements to study timelines.

Pioneered novel approaches to site qualification and closure, markedly improving trial timelines and resource allocation across oncology studies.

Drove substantial improvements in patient safety and study outcomes through meticulous oversight of trial protocols and data quality assurance measures.

CLINICAL RESEARCH ASSOCIATE (CONTRACTOR)Jan 2020 - Mar 2022

PPDSan Jose

Ensured data accuracy in cancer trials through detailed site visits, enhancing protocol compliance.

Facilitated effective communication between research sites and study teams, speeding up query resolution.

Reviewed clinical data meticulously, ensuring alignment with protocols and regulatory standards.

Provided protocol guidance and system training to research sites, improving study accuracy.

Conducted meticulous site visits, ensuring protocol adherence and data integrity in cancer trials. Optimised communication channels, accelerating query resolution processes.

Scrutinised clinical data for accuracy and completeness, aligning with study protocols and regulatory standards. Provided comprehensive protocol guidance to research sites.

Fostered strong relationships with research sites, facilitating smooth study operations. Delivered thorough system training, enhancing site capabilities and efficiency.

Streamlined data collection processes, significantly reducing query turnaround times. Implemented best practices for site management, improving overall study quality.

Developed novel strategies for enhancing site compliance, leading to improved data quality. Pioneered efficient communication methods between sites and study teams.

Conducted meticulous site visits for cancer trials, ensuring protocol adherence and data integrity. Streamlined communication channels to expedite query resolution.

Provided comprehensive protocol guidance and system training to research sites, enhancing study accuracy and site capabilities.

Developed novel strategies to enhance site compliance, leading to improved data quality. Pioneered efficient communication methods between sites and study teams.

Fostered strong relationships with research sites, facilitating smooth study operations. Acted as a liaison between sites and study teams for effective query resolution.

Conducted meticulous site visits for cancer trials, ensuring protocol adherence and data integrity. Optimised communication channels to expedite query resolution.

Streamlined data collection processes, significantly reducing query turnaround times. Implemented best practices for site management, improving study quality.

Pioneered efficient communication methods between sites and study teams. Developed novel strategies to enhance site compliance, leading to improved data quality.

DUTY MEDICAL OFFICERNov 2011 - Aug 2015

Omega Hospital - InternshipHyderabad,INDIA

Monitored clinical sites, ensuring protocol compliance and data integrity for improved patient outcomes.

Enhanced health education through inter-professional collaboration, boosting patient understanding.

Implemented advanced treatments, leading to faster recovery and reduced hospital stays.

Maintained patient records with precision, supporting evidence-based care and regulatory compliance.

Improved data accessibility by integrating digital record systems, reducing administrative tasks.

Streamlined patient recruitment process, accelerating study timelines and increasing successful trial completions.

Mentored junior staff in research methodologies and patient care, fostering a culture of continuous learning and professional development.

Analysed clinical data for protocol adherence, enhancing patient outcomes. Streamlined digital record systems, boosting data accessibility and reducing administrative workload.

Fostered inter-professional collaboration to elevate health education, significantly improving patient understanding and treatment compliance.

Pioneered advanced treatment protocols, resulting in notably faster recovery times and shorter hospital stays for patients.

Meticulously maintained patient records, supporting evidence-based care decisions and ensuring full regulatory compliance.

EDUCATION

BACHELOR'S OF MEDICINE2005 - 2011

LSMUUkraine

GRADUATED IN BACHELORS OF MEDICINE AT LUGANSK STATE MEDICAL UNIVERSITY.

SILICON VALLEY UNIVERSITY USA 2015-2017

COURSES

INTERNSHIPNov 2011 - Aug 2014

Omega Hospital

SKILLS

Clinical Monitoring (Skillful), Trial Management (Expert), Clinical Operations (Experienced), Site Management (Experienced), Protocol Adherence (Experienced), GCP Compliance (Experienced), Data Verification (Expert), Query Resolution (Expert), Site Initiation (Skillful), Site Close-out (Experienced), EDC Systems (Expert), CTMS (Expert), TMF Management (Expert), Regulatory Compliance (Expert), Patient Safety (Expert), Data Integrity (Expert).

ADDITIONAL INFORMATION

THERAPEUTIC PRODUCT AREAS

ONCOLOGY, ENDOCRINOLOGY,CARDIOLOGY

• Prostate Cancer

• Multiple Myeloma

• Solid Tumors

• Hypokalemia

• Ulcerative Colitis

• Non-cell lung cancer

COMPUTER/SYSTEM PROFICIENCY

• MS office; Excel, Word, and Power point

• EDC-oracle-RDC, INFORM, RAVE

• CTMS- I Medidata

• eTMF-Veeva Vault

• TI

HOBBIES

HIKING

LINKS

LINKEDLN: linkedin.com.

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