Bhumika Joshi
Clinical Research Associate
Navi Mumbai
Summary
Accomplished Clinical Research Associate with Two years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
5
5
years of professional experience
3
3
Language
Work History
Clinical Research Associate
Macleods Pharmaceuticals
Mumbai
01.2021 - Current
- Adhered to good clinical practices, operating procedures and regulatory requirements
- Monitored safety events reported during the course of clinical trials in accordance with SOPs
- Participated in internal audits related to clinical research operations processes
- Collected and authenticated data collection forms to read and interpret complex clinical protocols
- Completed day-to-day duties accurately and efficiently
- Reported to project manager for issues related to overall study status
- Gathered and reviewed study data
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants
- Conducted site initiation visits and monitored ongoing studies at investigator sites
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary
- Monitored site activities and sent follow-up letters to participants
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork
- Evaluated proof of eligibility and consent for participants
- Monitored subject enrollment and tracked dropout details.
Clinical Pharmacist
Max Hospital Saket
12.2016 - 09.2019
- Participated in formulary management activities such as evaluating new drugs for formulary inclusion or exclusion decisions based on cost-effectiveness criteria
- Monitored drug therapies by reviewing laboratory values and adjusting medications as needed
- Provided patients with information on how to properly take and store medication
- Counseled patients on drug therapies to ensure proper intakes
- Counseled patients on appropriate use of over-the-counter and prescription medications
- Investigated drug information requests from health care providers including indications, dosing regimens, contraindications, interactions, adverse reactions
- Reviewed patient medical records for drug allergies, interactions, and contraindications to ensure safe medication use
- Instructed physicians on correct medication dosages
- Developed policies and procedures related to clinical pharmacy services at the facility
- Advised patients on potential drug interactions and side effects, proper dose timing and medication storage.
Education
M.PHARMA - Clinical Pharmacy
SGRRITS
Dehradun, UttarakhandB.PHARMA - PHARMACY
SGRRITS
Dehradun, UttarakhandHSC - SCIENCE
BSSIC
Nainital, UttarakhandSSC - SCIENCE
BSSIC
Nainital, UttarakhandSkills
Research and Developmentundefined
Timeline
Clinical Research Associate
Macleods Pharmaceuticals
01.2021 - Current
Clinical Pharmacist
Max Hospital Saket
12.2016 - 09.2019
M.PHARMA - Clinical Pharmacy
SGRRITS
B.PHARMA - PHARMACY
SGRRITS
HSC - SCIENCE
BSSIC
SSC - SCIENCE
BSSIC
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