Ankur Sharma
Delhi NCR
Summary
Organised Clinical Research Associate with vast experience in organising, coordinating and overseeing clinical trials. Excellent communication and interpersonal skills. Manages study supplies, medication supplies and medication accountability with accuracy and precision.
Therapeutics Clinical Trials Phases Experience ( Research Associate )
- Oncology Phase 2 Study (Polycythemia Vera)
- Cardiovascular Phase 4 Study for Medical Device ( Coronary lesion Multivessels Disieases with Diabetic Patients )
- Phase 2 & Phase 3 Vaccines Studies (Tetanus, Diptheria, Covid 19, Chickenpox, Polysaccaride Pneumoccoal infection)
- Opthalmology Phase 1 Study (Macular Degeneration)
Therapeutics Clinical Trials Phases Experience ( Research Coordinator )
- Cardiovascular Study Study ( Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System)
- Oncology Phase 3 Study (Squamous Cell Carcinoma of the Head and Neck, Advanced or Metastatic Triple Negative Breast Cancer, Stage II-IIINSCLC)
Overview
6
6
years of professional experience
Work History
Clinical Research Associate
Clinical Research Network India Pvt Ltd
Delhi NCR
2023.05 - Current
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Reported to project manager for issues related to overall study status.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Provided training on GCP standards to new personnel or existing staff members.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Monitored site activities and sent follow-up letters to participants.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Performed pre-study, closeout and interim visits to check on study activities.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Checked electronic data capturing systems for integrity and compliance.
Clinical Research Associate
JSS Medical Research Asia Pacific Pvt Ltd
Faridabad Haryana
2021.07 - 2023.05
Clinical Research Coordinator
Max Healthcare Pvt Ltd
Delhi
2020.12 - 2021.04
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
Clinical Research Coordinator
Medanta Hospital Gurgaon Haryana
Gurgaon
2018.04 - 2020.11
Education
Master of Science - Clinical Research
Galgotia University
Gretor Noida Uttar Pradesh 2018-12
Bachelor of Science - Pharmacy
SGCP College of Pharmacy
Baghpat Uttar Pradesh 2016-01
Skills
- Data Collection
- Report Writing
- Project Monitoring
- Patient Recruitment Strategies
- Patient Safety
- Team Training
- Site Management
- Recruitment Strategies
- Good Clinical Practice
- Trip Reports
- Action Planning
- Monitoring Visits
Languages
English
First Language
English
Intermediate (B1)
B1
Timeline
Clinical Research Associate
Clinical Research Network India Pvt Ltd
2023.05 - Current
Clinical Research Associate
JSS Medical Research Asia Pacific Pvt Ltd
2021.07 - 2023.05
Clinical Research Coordinator
Max Healthcare Pvt Ltd
2020.12 - 2021.04
Clinical Research Coordinator
Medanta Hospital Gurgaon Haryana
2018.04 - 2020.11
Master of Science - Clinical Research
Galgotia University
Bachelor of Science - Pharmacy
SGCP College of Pharmacy
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