Meraman Varu
Clinical Research Site Manager
Lexington,KY
Summary
Motivated professional with great expertise in clinical research and regulatory documentation, spanning both small clinic and large hospital environments. Committed to continuous learning in the field of research, aspiring to advance into a role as a Clinical Research expert.
Overview
5
5
years of professional experience
1
1
year of post-secondary education
Work History
Clinical Program Manager/Coordinator
Medical University Of South Carolina
Florence, SC
11.2021 - 02.2024
- Established clinical research department within 3 months of joining with robust supply chain for research trial in rural hospital.
- Prepared & managed site level budget negotiation for research site and handling financial reports of research site.
- Site level patient recruitment increased from 0 to 15 patients weekly within first year.
- Managed research site including regulatory documents, staffs and inventory including laboratory and pharmacy of the research site.
- Maintained site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Helped research monitor in study initiation and closeout visit with data & documentations.
- Worked as a a back up coordinator and conducted 20-25 patients visit monthly including protocol required assessment, research procedures, lab sample collection & shipping in accordance with research protocol.
- Reported AEs/SAEs to PI, monitor and prepare documents to file IRB reports within protocol timeframe.
Learning: Site management, budget negotiation, regulatory documents, project management
Clinical Research Coordinator
Objective Health
Greenwood, SC
03.2021 - 11.2021
- Managed 5 clinical research studies independently with all required documentations.
- Reviewed EMR of 20-25 patients everyday & scheduled for screening visit.
- Obtained informed consent & recruited 2 to 3 pts daily in complex GI trials and performed required assessments like vitals, ECG, Fibro scan, blood draw and handling & shipping lab specimens.
- Resolved data queries and accurate reporting of AEs/SAEs to PI and monitor.
- Helped monitor during site study start-up, monitoring and study close-out visit.
- Assisted manager in maintaining clinical research regulatory documents and sponsors binders, pharmacy and lab equipment & supply.
- Briefed PI, Site manager and director about weekly research study progress, to-do list.
Clinical Research Assistant
Temple University Hospital
Philadelphia, PA
05.2019 - 05.2020
- Pre- screened 15 to 20 patients and scheduled patient for research visit.
- Educated patients about ICF, patient's right, screening process and assessments.
- Helped research coordinator in data entry, data management and document preparation for study visit.
Education
Master's of Public Health - Epidemiology
Temple University
Philadelphia, PA05.2020
M.D. - Medicine
B.J Medical College
Gujarat, India03.2017
MBA - Business Management & Administration
University of The Cumberlands
Williamsburg, KY 08.2023 - Current
Skills
- Research site management & Coordination
- Regulatory & Budget preparation
- Patient recruitment, Clinical Data Capture & Management
- Multiple study handling, study initiation and closeout
- Vitals, EKG and Lab specimens Collections & Handling
- Leadership, Communication, Attention to details
- Certificate: GCP, Biomedical Research, HIPAA Compliance, IATA, CPR
- Tech: MS Office Suite, Epic, iMedidata, Redcap, Endpoint, CRIO, SAS
- Trial Experience: Pulmonary, Cardiology, Gastrointestinal, Psychology, Oncology
Quote
Every problem is a gift—without problems we would not grow.
Tony Robbins
Timeline
MBA - Business Management & Administration
University of The Cumberlands
08.2023 - Current
Clinical Program Manager/Coordinator
Medical University Of South Carolina
11.2021 - 02.2024
Clinical Research Coordinator
Objective Health
03.2021 - 11.2021
Clinical Research Assistant
Temple University Hospital
05.2019 - 05.2020
Master's of Public Health - Epidemiology
Temple University
M.D. - Medicine
B.J Medical College
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