Komal Makwana
Manhattan,NY
Summary
Proficient in managing patient information and ensuring compliance across diverse clinical trials, supported by exceptional organizational and communication skills.
Overview
14
14
years of professional experience
1
1
Certification
Work History
CLINICAL RESEARCH COORDINATOR
CHEAR CENTER LLC
The Bronx, USA
06.2022 - 04.2025
- Coordinated Phase I-IV trials across diverse therapeutic areas, enrolling over 50 participants.
- Oversaw study protocols, including patient recruitment and informed consent processes.
- Maintained regulatory documents to ensure adherence to IRB submissions and FDA standards.
- Managed data entry within EDC systems, resolving queries and facilitating audits.
- Collaborated with principal investigators, sponsors, and monitors during site initiation and trial closures.
- Assisted in tracking budgets, submitting invoices, and managing investigational products effectively.
CLINICAL RESEARCH COORDINATOR
GENERAL HOSPITAL
, INDIA
01.2015 - 10.2019
- Ensured compliance with ICH-GCP and FDA regulations through meticulous maintenance of TMF.
- Facilitated patient interactions during Phase II-IV observational studies in cardiovascular and oncology.
- Performed effective patient screening, prescreening, and randomization processes.
- Secured informed consent from participants for various clinical trials through counseling.
- Managed accountability of investigational products while upholding ALCOA principles.
- Coordinated organization of trial documentation and rooms to streamline consenting procedures.
- Handled logistics for shipping test samples, ensuring integrity throughout the process.
- Updated clinical trial documentation, including CRFs and eCRFs, according to source documents.
Lab Technician
Madhiram Private lab
, INDIA
03.2011 - 01.2012
- Accurately collected, labeled, centrifuged, and stored specimens following established protocols.
- Handled blood, tissue, urine, and microbial samples under sterile conditions to ensure safety.
- Maintained cell lines through subculturing while employing aseptic techniques.
- Executed staining techniques such as Gram staining and immunofluorescence for analysis.
- Conducted light and fluorescence microscopy to examine cellular structures comprehensively.
- Ensured adherence to GLP and laboratory safety protocols consistently.
- Performed regular equipment maintenance and managed calibration logs diligently.
- Oversaw waste disposal procedures to meet safety standards effectively.
Education
Post Secondary Education - Clinical Research Training
Arizona State Board For Private Postsecondary Edu.
USA10.2021
Some College (No Degree) - Clinical Research
IICR
INDIA02-2015
Master of Science - Nanoscience and Technology
CHARUSAT University
INDIA12.2014
High School Diploma -
GITE
INDIA06-2011
Bachelor of Science - Biotechnology
SMU University
INDIA03.2011
Skills
- Pulmonary function testing
- Electronic data capture management
- Document management systems
- Ethics committee compliance
- Medical vocabulary proficiency
- Digital literacy skills
- Laboratory methodologies
- Financial oversight
- Protocol compliance in studies
- Reporting adverse events
Certification
- GCP training
- PFT training
Timeline
CLINICAL RESEARCH COORDINATOR
CHEAR CENTER LLC
06.2022 - 04.2025
CLINICAL RESEARCH COORDINATOR
GENERAL HOSPITAL
01.2015 - 10.2019
Lab Technician
Madhiram Private lab
03.2011 - 01.2012
Post Secondary Education - Clinical Research Training
Arizona State Board For Private Postsecondary Edu.
Some College (No Degree) - Clinical Research
IICR
Master of Science - Nanoscience and Technology
CHARUSAT University
High School Diploma -
GITE
Bachelor of Science - Biotechnology
SMU University
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