Work EXPERIENCES & Job Discription

Work Experience

• Commencement of teaching career on 21^th 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) .

Research experience

• 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”

Job discription

Responsibilities As a CRA

1. 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

2. 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

3. 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.

4. 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.

5. 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.

6. 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

7. 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