Rajkumari Bhardwaj
Summary
Experienced in coordinating patient information, laboratory samples, and compliance documents for a variety of clinical trials. Versatile and knowledgeable clinical research professional with strong organizational skills and attention to detail. Excels in planning and problem-solving to ensure smooth operations throughout the trial process.
Overview
9
9
years of professional experience
Work History
Clinical Research Coordinator (Cardiology)
Westchester Medical Center
05.2024 - Current
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
Clinical Research Coordinator (Oncology)
Medstar Washington Hospital Center
06.2022 - 04.2024
- Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards and safety standards. Complies with governmental and accreditation regulations
- Explained informed consent process and study details to research participant; obtained required signatures and documented process in source document.
- Develop and implement recruitment strategies, including central recruitment core, to attract and onboard research participants for studies.
- Entered and maintained case report forms, reviewing data against participant medical records to ensure completeness and accuracy. Addressed queries and communicated with sponsors/CROs. Submitted forms promptly.
- Collects, processes, and ships biospecimens and pharmacokinetics correctly (e.g., centrifuge, freezing, refrigeration). Kept Occupational safety and Health Administration (OSHA) training up to date for bloodborne Pathogens. Assists in equipment maintenance (e.g., calibration, preventive maintenance).
- Study conduct responsibilities include research participant interviews and assessments at study visits as required by protocol; attending investigator meetings as appropriate and communicating relevant information to the research team; understanding and proficiently communicating all components of research documents, such as protocol, investigator brochure and research instructions.
- Ensured proper identification, documentation, and reporting of non-serious and serious adverse events based on applicable requirements; provided relevant information to investigators for determining seriousness, causality, and intervention; implemented investigator's recommendations for adverse event intervention such as halting test article, contacting research participants, conducting re-tests or providing treatment; maintained thorough follow-up to track resolution of adverse events.
- Ensured timely routing of stipends for research participants. Understands and complies with regulations governing billing in clinical studies.
- - Liaising and maintaining effective communication with research participants, investigators, sponsors, and healthcare professionals. - Facilitating site qualification, study initiation, monitoring, and close-out visits with meticulous preparation. - Updating all research participant encounters promptly in the clinical trail management system (CTMS) while collaborating harmoniously with diverse multidisciplinary research teams.
- Acquired foundational knowledge of Good Clinical Practices (GCP) from the International Conference on Harmonization (ICH), along with essential training including Collaborative Institutional Training Initiative (CITI), Conflict of Interest (COI), and annual Medstar Health mandatory.
- Performs other duties as assigned.
Clinical Research Coordinator (Thoracic Surgery)
Northwell Health
02.2022 - 05.2022
- Researcher screening, assist in consenting qualifying subjects per Northwell Policy and Procedure, assisting in enrollment processes, clinical data entry and query resolution and all research related activities while adhering to research protocols, local IRB and IRB of record.
- Responsible for the collection of data and may contribute to the analysis and interpretation of research data for PI initiated projects.
- Responsible for the maintenance of specific research and clinical databases;handle export and queries of the data for use in PI initiated projects as applicable; enter data and manage all EDC coordinator related tasks for sponsor supported studies.
- Demonstrate understanding of thoracic surgery, oncology and other medical terms as non-clinician; understands escalation policy for data source verification.
- Attend and scribe for regularly scheduled research PI meetings; prepare the agenda for research meetings and maintain accurate records; prepare AE reports and PD reports for study.
- Understand and comply with WIRB and Northwell Health IRB policies.
- Follow and understand Workflow of the office/Office Policies/Northwell Health policies.
- Oversee and manage the Primary Lung Cancer Registry Database- handle simple data entry, run report for regular review, assign students case entries- coordinate student work flow and case entries.
- Understand basic regulatory processes including AE reporting, maintaining AE and PD logs, reporting to IRB of record.
- Learn how to submit new study and maintain regulatory processes including continuing review and study close outs.
Clinical Research Coordinator (Gastroenterology)
NY Scientific Corp
04.2019 - 02.2022
- Worked with pharmaceutical companies to undergo clinical trials and provide subjects with supplied medicine
- Monitored subjects and record adverse events- ensuring to record if the subjects began experiencing any new EDUCATION AND TRAINING changes and side effects
- Communicated with subjects' primary doctor to receive medical history when necessary Verified dates, visit and subject numbers to send off for study approval
- Determined subjects' eligibility for clinical trials by confirming and verifying all necessary medical history and requirements Inspected subject lab reports for any abnormalities and report them to the doctor to determine eligibility
- Answered incoming phone calls in professional manner
- Provided information to answer subjects concerns, and schedule appointments
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Managed study budgets and resources to maximize return on investment while maintaining quality standards.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Performed phlebotomy on subjects
Clinical Research Coordinator (Gastroenterology)
NY Scientific Corp
09.2015 - 12.2016
- Worked with pharmaceutical companies to undergo clinical trials and provide subjects with supplied medicine
- Monitored subjects and record adverse events- ensuring to record if the subjects began experiencing any new EDUCATION AND TRAINING changes and side effects
- Communicated with subjects' primary doctor to receive medical history when necessary Verified dates, visit and subject numbers to send off for study approval
- Determined subjects' eligibility for clinical trials by confirming and verifying all necessary medical history and requirements Inspected subject lab reports for any abnormalities and report them to the doctor to determine eligibility
- Answered incoming phone calls in professional manner
- Provided information to answer subjects concerns, and schedule appointments
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Managed study budgets and resources to maximize return on investment while maintaining quality standards.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Performed phlebotomy on subjects
Education
No Degree - Medical Assistant Certification
Allen School of Health Sciences
Jamaica, NY07.2015
Bachelor of Arts - Arts
Delhi University
India05.2012
Skills
- GCP Certified
- IATA Certified
- Phlebotomy
- Vital Signs
- EKG
- Laboratory Procedure
- Medication dispensing
- Trial management
- Trial Management
- Electronic Data Capture
- Documentation Management
- Adverse event reporting
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Timeline
Clinical Research Coordinator (Cardiology)
Westchester Medical Center
05.2024 - Current
Clinical Research Coordinator (Oncology)
Medstar Washington Hospital Center
06.2022 - 04.2024
Clinical Research Coordinator (Thoracic Surgery)
Northwell Health
02.2022 - 05.2022
Clinical Research Coordinator (Gastroenterology)
NY Scientific Corp
04.2019 - 02.2022
Clinical Research Coordinator (Gastroenterology)
NY Scientific Corp
09.2015 - 12.2016
No Degree - Medical Assistant Certification
Allen School of Health Sciences
Bachelor of Arts - Arts
Delhi University
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