AVINASH RAO K A
BENGALURU
Summary
Dynamic Clinical Research Associate with a proven track record at IQVIA, excelling in cross-functional coordination and risk management strategies. Leveraged expertise in Good Clinical Practice and exceptional problem-solving abilities to enhance project outcomes and safety protocols. Achieved significant improvements in study design and patient recruitment, demonstrating adaptability and a commitment to excellence.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Consultant
AMERICAN SOCIETY OF REDRODUCTIVE MEDICINE
WASHINGTON DC
06.2022 - Current
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Worked with cross-functional teams to achieve goals.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Identified needs of customers promptly and efficiently.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Assisted with customer requests and answered questions to improve satisfaction.
- Maintained updated knowledge through continuing education and advanced training.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Approached customers and engaged in conversation through use of effective interpersonal and people skills.
- Provided support and guidance to colleagues to maintain a collaborative work environment.
- Exceeded customer satisfaction by finding creative solutions to problems.
- Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
- Recognized by management for providing exceptional customer service.
- Utilized various software and tools to streamline processes and optimize performance.
- Conducted comprehensive research and data analysis to support strategic planning and informed decision-making.
- Achieved cost-savings by developing functional solutions to problems.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Worked effectively in team environments to make the workplace more productive.
Clinical Research Associate
IQVIA
BENGALURU URBAN
02.2021 - 10.2021
- Performed clinical research activities including protocol development, subject recruitment and data collection.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Developed and managed budgets for clinical trials according to study protocols.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Provided support in writing informed consent forms, patient diaries, study manuals.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Prepared reports summarizing study progress and results for senior management review.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Drafted agendas, minutes and other meeting materials for Investigator Meetings or Advisory Boards.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Managed relationships with external vendors such as laboratory services or imaging centers.
- Participated in internal audits related to clinical research operations processes.
- Provided training on GCP standards to new personnel or existing staff members.
- Maintained strict confidentiality to keep personal information and collected data private.
- Participated in educational training, activities, and professional development programs.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Evaluated proof of eligibility and consent for participants.
- Achieved project-specific quality and performance standards and provided documentation and communication.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Attended meetings and reported on activities and resolutions.
- Reported to project manager for issues related to overall study status.
- Checked electronic data capturing systems for integrity and compliance.
- Monitored site activities and sent follow-up letters to participants.
- Held weekend and evening sessions according to project specifications and workload.
- Communicated with vendors to deliver appropriate clinical supplies to key areas and meet ongoing operational demands.
- Organized, analyzed and modeled study data.
- Reviewed adverse drug reaction reports from healthcare professionals and patients to determine causality.
- Analyzed patient medical histories, laboratory results, and other relevant information to assess potential risks associated with medication use.
- Collaborated with internal teams to ensure timely completion of safety data collection activities.
- Conducted literature searches to identify safety signals for specific drugs or classes of drugs.
- Developed standard operating procedures related to safety data collection and reporting processes.
- Provided guidance on the development of pharmacovigilance plans and strategies.
- Assessed the impact of new regulations on existing pharmacovigilance systems.
- Performed quality assurance reviews of case processing activities.
- Participated in risk management plan meetings with internal stakeholders and external partners.
- Investigated product complaints reported by customers regarding adverse events associated with medications.
- Compiled periodic safety update reports for review by senior management team members.
- Prepared written summaries of findings from pharmacovigilance investigations for regulatory submission purposes.
- Monitored social media channels for emerging trends in medication use patterns and side effects reported by users.
- Maintained up-to-date knowledge of applicable FDA regulations governing drug safety reporting requirements.
- Coordinated communication between cross-functional teams during urgent safety issues requiring immediate action.
- Assisted in the preparation of training materials related to pharmacovigilance best practices.
- Generated detailed reports containing analysis of postmarketing surveillance data collected from multiple sources.
- Evaluated clinical trial protocols for compliance with international standards pertaining to drug safety monitoring.
- Researched current literature to stay abreast of new developments in the field of pharmacovigilance.
- Developed effective strategies for identifying, documenting, and responding to drug safety issues.
- Provided guidance on appropriate coding conventions for adverse event terms used in medical records.
- Followed confidentiality rules to preserve data quality and reduce potential information compromise.
- Collaborated closely with healthcare professionals to monitor and assess quality and effectiveness of drugs or drug regimens.
- Monitored quality assurance and quality control activities by reviewing data quality and making field visits.
- Implemented quality control assessments to promote improved reviews of data.
- Prepared technical reports and research articles for scientific trade journals and presentations to groups.
- Recorded patient vital signs for medical review.
- Evaluated and assessed patients by reviewing medical history.
- Trained employees in proper equipment use and product testing procedures.
- Monitored and upheld safe operating procedures and clean area mandates to meet regulatory requirements.
- Identified quality problems and recommended solutions.
- Analyzed issues and recommended corrective actions to improve final results.
- Performed visual inspections of finished products.
- Conducted tests on product samples and recorded results.
- Monitored testing procedures to meet established item specifications, standard test methods or protocols.
- Received and inspected raw materials.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
- Maintained lab cleanliness and safety standards.
- Calibrated, validated or maintained laboratory equipment.
- Investigated or reported questionable test results.
- Identified and troubleshot equipment problems.
- Interpreted test results, compared to specifications and control limits and recommended data for release.
- Completed data capture forms, equipment logbooks or inventory forms to support testing procedures.
- Performed quality control inspections at customer sites to determine alignment with safety regulations.
- Compiled laboratory test data and performed analyses.
- Conducted routine and non-routine analyses of in-process materials or stability samples.
- Trained other analysts to perform laboratory procedures and assays.
- Outlined remediation plans to standardize results to meet compliance regulations.
Education
Doctor of Pharmacy PHARM .D - Clinical Research
AL AMEEN COLLEGE OF PHARMACY
BENGALURU KARNATAKA09-2028
DIPLOMA IN PHARMACY - PHARMACY
VIVEKANANDA COLLEGE OF PHARMACY
BENGALURU INDIA08-2017
PRE UNIVERSITY EDUCATION SCIENE PCMB - SCIENCE PCMB
SRI BHAGAWAN MAHAVEER JAIN COLLEGE
KOLAR GOLD FIELDS KARNATAKA03-2014
HIGH SCHOOL - 10TH STANDARD
BETHESDA HIGH SCHOOL
BENGALURU INDIA04-2010
Skills
- Monitoring visits
- Protocols development
- Good clinical practice
- Protocol adherence
- Trip reports
- Accountability
- Interactive management
- Cross-functional coordination
- Risk management strategies
- Signal detection
- Safety Protocols
- Problem-solving aptitude
- Coordinate testing
- Documentation
- Problem-solving abilities
- Laboratory computer systems
- QMS
- Computer Proficiency
- Root Cause Analysis
- Lean Manufacturing
- Multitasking Abilities
- Protocol development
- Risk Assessment
- Documentation skills
- Quality audits
- Analysis
- Compile data
- Multitasking
- Communication Skills
- Adaptability
- Quality Inspection
- Professionalism
- Calibration
- Sampling protocols
- Six Sigma Methodologies
- Process Improvement
- Regulatory Compliance
- Sampling procedures
- Data Collection
- Project Management
- Time management abilities
- Record-keeping
- Quality Assurance
- Reporting skills
- Quality Management Systems
- Drug development
- Action planning
- Integrated medical reporting
- Patient recruitment
- Study design
- Completing regulatory documents
- Project monitoring
- Site monitoring
- Reviewing data standards
- Detailed documentation
- Patient recruitment strategies
- NDAs
- Coordinating site operations
- Coordinating supplies
- Reporting writing
- Client rapport
- Content management system
- Reports and documentation
- Diagnostic expertise
- Clinical Decision Making
- Public health education
- Emergency medicine
- Preventive medicine
- Performance Improvement
- Community health
- Infection control procedures
- Clinical assessment
- Medical consultations
- Geriatric medicine
- Obstetrics and gynecology
- Risk Management
- Intervention monitoring
- Patient Management
- Scientific Writing
- Diagnosis and prognosis
- Laboratory procedures
- Evidence-Based Practice
- Medical Research
- Medical equipment usage
- ICD-10
- Wound care management
- Attention to Detail
- Conflict Resolution
- Organization and Time Management
- Critical Thinking
- Fluent In Language
- Research
- Task Prioritization
- Problem-Solving
- Medicine
- Evidence-based medicine
- Dispensing medicines
- Emergency Medicine Pharmacology
- Critical Care Medicine
- Power BI
- Big data technologies
- Data science research methods
- Deep learning
- Communication
- Machine Learning
- Data operations
- Microsoft Azure
- Data Analysis
Languages
Telugu
First Language
Hindi
Advanced (C1)
C1
Urdu
Elementary (A2)
A2
Tamil
Elementary (A2)
A2
English
Proficient (C2)
C2
Turkish
Beginner (A1)
A1
Kannada
Advanced (C1)
C1
French
Beginner
A1
Spanish
Beginner
A1
Certification
- OfficeMaster - Microsoft Excel Using AI workshop - Excel Using AI Workshop - October 2024
- Emerging Pharmaceutical Technologies Meet - 2018 - Ratnam Institute of Pharmacy Nellore Andhra Pradesh
- Workshop on importance of SAS and SPSS in Research and Industry - 2022 -CliMED Research Solutions INDIA
- Short term training programme on Research writing and Publishing - April 2022
- CME PROGRAMME On "Healthcare associated infections and Antimicrobial Stewardship - by KLE -Suchirayu Hospital Hubli -March 2022
- Advanced Program in Clinical Research and Management - CLINI INDIA - August 2020
- ATRIA BIOSCIENCES - Advace PG diploma in Clinical Research and Pharmacovigilance - December 2020
- Workship Good Clinical Practice (GCP) Workshop for Investigator and Clinical Research Professionals - Indian Society for Clinical Research (ISCR) July 2022
- Webinar on " Clinical Research and Job Opportunities - Cli Med Research Solutions April 2022
- Clinical Oncology - Biogrademy June 2022
- Clinical Oncology - Anti-Microbial Stewardship June 2022
- Clinical Infertility - American Society Of Reproductive Medicine Washington DC USA June 2022
- Clinical Diabetology Pharmacotherapy - Master Course Geethanjali University - Udaipur Rajasthan INDIA June 2022
- Clinical Cardiology - Basic Diseases June 2022
- DECON 2022 8TH International Diabetes and Endrocrinology Conference - PARDECON 2022
- Drug Safety and Risk Managaement in Oncology care 2022
Membership
- Membership in World Health Organisation
- Membership in UNICEF India
- Membership in Comprehensive Cancer Network
- Membership in Global Health
- Membership in Fertility Focus Limited
- Membership in Forever Living Products
- Membership in ARSM - American Reproductive Society Medicine
- Membership in Society for Reproductive and Fertility Middlesex United Kingdom
- Membership in Clinical Research Association of Canada
- Membership in Healthcare India
- Membership in Indian Society For Clinical Research
Affiliations
- Multi-Tasker
- Critical Thinker
- Problem Solver
- Spirituality
Hobbies
- Indian Railways
- Airways
- Reading books
- Listening Music
- Travel
References
References available upon request.
Timeline
Consultant
AMERICAN SOCIETY OF REDRODUCTIVE MEDICINE
06.2022 - Current
Clinical Research Associate
IQVIA
02.2021 - 10.2021
- OfficeMaster - Microsoft Excel Using AI workshop - Excel Using AI Workshop - October 2024
- Emerging Pharmaceutical Technologies Meet - 2018 - Ratnam Institute of Pharmacy Nellore Andhra Pradesh
- Workshop on importance of SAS and SPSS in Research and Industry - 2022 -CliMED Research Solutions INDIA
- Short term training programme on Research writing and Publishing - April 2022
- CME PROGRAMME On "Healthcare associated infections and Antimicrobial Stewardship - by KLE -Suchirayu Hospital Hubli -March 2022
- Advanced Program in Clinical Research and Management - CLINI INDIA - August 2020
- ATRIA BIOSCIENCES - Advace PG diploma in Clinical Research and Pharmacovigilance - December 2020
- Workship Good Clinical Practice (GCP) Workshop for Investigator and Clinical Research Professionals - Indian Society for Clinical Research (ISCR) July 2022
- Webinar on " Clinical Research and Job Opportunities - Cli Med Research Solutions April 2022
- Clinical Oncology - Biogrademy June 2022
- Clinical Oncology - Anti-Microbial Stewardship June 2022
- Clinical Infertility - American Society Of Reproductive Medicine Washington DC USA June 2022
- Clinical Diabetology Pharmacotherapy - Master Course Geethanjali University - Udaipur Rajasthan INDIA June 2022
- Clinical Cardiology - Basic Diseases June 2022
- DECON 2022 8TH International Diabetes and Endrocrinology Conference - PARDECON 2022
- Drug Safety and Risk Managaement in Oncology care 2022
Doctor of Pharmacy PHARM .D - Clinical Research
AL AMEEN COLLEGE OF PHARMACY
DIPLOMA IN PHARMACY - PHARMACY
VIVEKANANDA COLLEGE OF PHARMACY
PRE UNIVERSITY EDUCATION SCIENE PCMB - SCIENCE PCMB
SRI BHAGAWAN MAHAVEER JAIN COLLEGE
HIGH SCHOOL - 10TH STANDARD
BETHESDA HIGH SCHOOL
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