Parulben Patel
@parulbenpatel
Clinically trained clinical research specialist driving compliant, high-quality medical device trials.
IndiaWhat I'm looking for
I am a medically trained clinical research specialist with a Ph.D. and an M.H.A., bringing hands-on experience in medical device clinical trials across neurosurgery, wound care, surgical reconstruction, orthopedics, and cardiovascular areas. I have led study design, site selection, IRB submissions, monitoring activities (SQV, SIV, COV), EDC review, safety reporting (AEs/SAEs), and maintained CTMS and eTMF for audit readiness.
I mentor and train CRAs and site staff, coordinate cross-functional teams and vendors, and manage clinical trial documentation, budgets, timelines, and regulatory compliance (ICH-GCP, SOPs). My background as an educator and physician strengthens my clinical judgment and ability to support complex trials from start-up through close-out.
Experience
Work history, roles, and key accomplishments
ILDesigned, planned, and implemented clinical studies for medical devices, managing CTAs, budgets, timelines, and resources while overseeing site selection, monitoring, and IRB submissions to ensure compliance with ICH-GCP and internal SOPs.
ILServed as primary liaison for study sites, managing study start-up, monitoring, regulatory document approvals, translations, and quality checks to maintain compliance with SOPs, GCP and ICH guidelines.
ILManaged site qualification, initiation, interim monitoring, and close-out activities for tissue technology, wound care, surgical reconstruction, orthopedics, and neurosurgery studies, ensuring data integrity and subject safety.
General Physician / Associate Professor
S.B.K.S. Medical Institute and Research Center
May 2006 - Jul 2009 (3 years 2 months)
Participated in and coordinated clinical research projects and taught medical, dental, nursing, and physical therapy students, contributing to academic research and clinical education.
Education
Degrees, certifications, and relevant coursework
Gujarat University
Ph.D., Medical
Awarded a Ph.D. in Medical studies from Gujarat University completed in 2009.
Sardar Patel University
Master of Science, Medical Anatomy
Completed Master of Science in Medical Anatomy in 2001.
UVUniversity of Nevada, Las Vegas
Master of HealthCare Administration, Healthcare Administration
2013 -
Completed Master of Healthcare Administration studies at University of Nevada, Las Vegas beginning in 2013.
M.S. University, Gujarat
Bachelor of Medicine, Bachelor of Surgery, Medicine
Completed Bachelor of Medicine and Bachelor of Surgery (MBBS) in 1996.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Website
integralife.comJob categories
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