Harshita Gahankari
Clinical Research Associate @Miltenyi Biomedicine
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WORK HISTORY
Clinical Research Associate @Miltenyi Biomedicine
Boston, MA, US
EDUCATION
Savitribai Phule Pune University
Bachelor's of Pharmacy, Pharmacy, Pharmaceutical Sciences, and Administration
Northeastern University
Master of Science (M.S.), Regulatory Affairs of Drugs, Biologics, and Medical Devices
St. Xavier's College
Post Graduate Degree in Clinical Research, Clinical Research
SKILLS
ABOUT HARSHITA GAHANKARI
An Intent Clinical Operations and Regulatory Affairs Professional with an up-to-date knowledge of laws and regulatory compliance requirements as well as maintaining a thorough knowledge of FDA regulations, especially in the areas of clinical trials and regulatory submissions. Result-oriented and experienced Biopharmaceutical professional, SOCRA certified with strong experience in Clinical Operations/Research (Phase I-IV) along with Sponsored, Investigator-initiated, multi-center clinical trials, Regulatory Submissions and Compliance.Lead all aspects of the trial process (Phase trials of various therapeutics areas including cardiovascular, renal diseases with a main focus on Oncology) from initiation through the close-out, including vendor selection, qualification, site feasibility and selection, and maintain trial budget and timelines. Strong experience in PV operations (safety AE/SAE reconciliations), Quality systems (SIV/Monitoring visits/Close out visits, safety monitoring, audit/inspection readiness, Budget/contract review/CRO/External vendor oversight. Work collaboratively with cross-functional teams to ensure proper identification/selecting/monitoring of sites for studies, manage IP accountability, negotiate budgets/payments and oversee CROs/vendors.Areas of Interest include Clinical Operations, Regulatory Affairs, Medical Writing, Pharmacovigilance, Quality Assurance, Safety Review.Skills- SOCRA Certified Clinical Professional - Audit/Inspection Readiness for Phase trials of Oncology- Medical Device development and regulations, Quality System Regulations- 510 K, PMA, IND, NDA, IDE\'- Clinical trial laws and regulations, Clinical Trial Agreements, Informed Consent Process, CTD Format- ICH Guidelines, GLP, GCP, GMP requirements- Regulatory Medical Writing including Clinical Trial Protocols, IND, NDA submissions, Informed Consent Form, Investigator\'s Brochure, Standard Operating Procedures, Manuscript Descriptions and Literature Reviews of various National and International Journal Articles- Product Dossiers, Labeling Regulations & Laws, Activation of new protocols & amendments, CAPA identification, Creation of Advisory Boards, Scientific Meetings, Steering Committees, Food, Drug, Med Dev, Cosmetic Case Laws
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