Commencement of teaching career on 21th September 2013 to 20 Aug. 2014 as an Asst. Prof. at TVM College of Pharmacy, Bellary, Karnataka.
Worked as a Part time Clinical research coordinator (CRC) at KLES Dr. Prabhakar Kore Hospital and MRC, KLE University, Belagavi, Karnataka.
Worked as a assistant professor at Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, KAHER (Deemed-to-be University) Karnataka from May 2017 to Jun 2020.
Worked as a Medical writer and Clinical Research Associate at CBCC Global Research LLP from Jul 2020 to Sep 2022
Currently Working as a Clinical Research associate at Dr. Reddy's Laboratory (Biologics) .
During the post- Graduation in Pharmacy Practice – submitted a dissertation based on empirical research on the topic of “Comparative effect of racemic Amlodipine and its enantiomer with Atenolol on hypertensive patients – A Randomized, Parallel Group study".
Worked as a clinical research coordinator in phase II BA/BE study on Metastatic Brest Cancer and schizophrenia trial and phase III trials.
During the Ph.D in Pharmacy Practice (Psychiatry) – submitted a thesis based on empirical research on the topic of “Effect of Pharmaceutical care on enhancement of safety, medication adherence and quality of life in patient with Bipolar disorder: A prospective study in tertiary care hospital”
Responsibilities As a CRA
Facilitate Study Start up activities at Clinical Investigational Site
· Conduct Feasibility & assess the data
· Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project team
· Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions
· Identify the training needs for the site to perform adequate conduct of trial
· Ensure supply of clinical trial material to sites before study initiation
End to End clinical investigational site management:
· Initiate the study at clinical investigational sites
· Provide study protocol and related trainings
· Perform review of Informed Consent forms and narrative
· Perform review of source records, perform SDV
· Review of CRF data entry, data queries and coordinate with sites to resolve
· Ensure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closure
IP accountability and reconciliation
· Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites
· Provide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjects
· Identification of any temperature excursions and suitability of IP for subject administration
· Ensure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same.
· Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file.
Site Contracts and Site Payment Coordination
· Coordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicable
· Ensure that site invoices are being generated as per clinical trial agreement
· Review and approval of site invoices and submission to payment processing team
· Coordinate for the payment release & confirm for site acknowledgements
· Perform ongoing reconciliation of payments against site activities including subject visits conduct etc.
Liaising with Internal & External Stakeholders
· Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same.
· Ensure that the Bio-analytical samples are stored as per storage conditions mentioned in the lab manual including reconciliation and query resolution
· Liaising with other vendors and help sites in any query resolutions for vendor related activities
· Liaising with internal project teams including but limited to Data Management for EDC issues, data queries and reconciliations, Safety team for SAE related issues, Medical team for any protocol / eligibility related queries etc.
Ensuring Compliance to Protocol & Applicable study plans, SOPs, GCP and regulatory requirements
· Ensure compliance to Protocol
· Ensure compliance to study plans, applicable SOPs and related regulatory requirements
· Ensure compliance to ICH GCP
· Ensure compliance to good documentation practices including ALCOA-C
· Identification of significant deviations to protocol / plans / procedures, escalation to project lead / clinical ops lead and propose adequate mitigation plans / CAPA, Review of implementation of CAPA / mitigation plans, Identify need for training and provide training / re-training in case of any changes
· Support audits, inspections / QC visits, as required per study plans
Trial Master File Review and Maintenance for Inspection Readiness
· Ensure that sites are timely updating the documents in Investigator site file
· Retrieval of essential documents from sites for In house filing / Central files
· Review of onsite and in house files at defined frequency per monitoring / TMF plan for study
· Ensure adequacy of TMF for all time inspection readiness