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Clinical Research Assistant

Location:
Vasant Nagar, Karnataka, India
Posted:
March 27, 2020

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Resume:

Page * of *

Murali B M

Bengaluru, India

Phone: +91-984******* Email: adchb5@r.postjobfree.com Objective

To utilize my knowledge towards a challenging career in growth oriented, leading organization where professionalism and perfection is respected and which will provide ample opportunities for continuous growth and advancement.

Qualification:

B. Sc (Nursing) 2009 Rajiv Gandhi University of Health Sciences PUC 2005 Department of Pre-University Education

SSLC 2003 Karnataka State SSLC Board

Qualifications Summary:

State-licensed Nurse & phlebotomist backed by seven and half years of experience with research Laboratories settings.

Skillful and precise in performing venipuncture and capillary punctures, collecting, preparing and storing blood samples, and verifying medical records, ICU management.

Possess excellent patient-relations skills – known for having a gentle touch and the ability to alleviate patient anxieties.

Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials.

Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.

Encompasses content required at the site level to run a study. Key Competencies:

Venipuncture

Blood Collection & Handling Safety

Medical Records Review

Clinical trial operations

Technical skills- MS office -word, excel,

power point.

Blood Specimen Storage

Patient & Donor safety consideration

Quality Assurance & Controls

ICU/ Emergency management

Study specific and site review

ICH-GCP, GDP, Schedule Y.

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Current Professional Experience:

BioQuest Solutions Pvt Ltd.

Senior Clinical Research Associate

Bangalore, India.

From 20 May 2019 – Present

Brief description of role & responsibilities:

• Recruitment at sites as per the expected target, in the allotted time

• Compliance to the project management plan with respect to all study execution related activities

• Follow-ups with sites and relay of information to internal/external stakeholders

• Preparation and updating tracker on an ongoing basis and communicated to project manager

• Compliance with the monitoring plan, coordinating with study site and conducting site monitoring visits.

• Prompt issue escalation at the site level

Reporting to: Group Head / Manager

Previous Professional Experience:

G7 Synergon Pvt Ltd

Senior Clinical Research Associate

Bangalore, India.

From 19 July 2018 – 30 Apr 2019

Brief description of role & responsibilities:

• Feasibility analysis, identification, and selection of Potential Investigators (PI).

• Assists developing trial management systems.

• Planning and coordination of investigator meetings (IM) and prepare presentation materials.

• Management of recruitment strategies when necessary.

• Identifying risks, raising CAPA’s, providing trainings and risk mitigation plans.

• Management of study drug/supply/equipment shipment, accountability, archival and retention.

• Performing site initiation, monitoring and closeout visits.

• SOP Preparation,

Reporting to: Project Manager / Head Clinical Operations.

Norwich Clinical Services Pvt Ltd.

Clinical Trial Assistant

Bangalore, India.

From 20 Jun 2016 – 27 Dec 2017

Brief description of role & responsibilities:

• Collect and review essential documents from study sites. Page 3 of 4

• Monitor the conduct of clinical trial as per protocol at multiple sites.

• Executes other duties may be assigned by the clinical operation management.

• Responsible for maintaining all records pertaining to the processes.

• Maintain and update of the Monitor’s & Main Study File.

• Responsible for implementation of corrective and preventive actions

• Facing Audits (Sponsors Audit, FDA, WHO, ANVISA, DCGI)

• Trial management, blind and un-blinding procedures, data handling, record keeping, allocation of duties & functions.

Reporting to: Project Manager / Head Clinical Operations.

Lotus Labs Pvt Ltd.

Clinical Research Nurse and Coordinator

Bangalore, India.

From 02 Aug 2010 – 18 Jun 2016

Brief description of role & responsibilities:

• Providing immediate comprehensive nursing care and emergency management.

• Obtain blood samples for medical testing, screening through venipuncture or capillary puncture.

• Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

• Volunteer’s recruitment and obtaining General consent for participation in clinical trials.

• Follow infection-control and safety procedures in carrying out daily phlebotomy functions.

• Prepare blood-collecting equipment, draw blood, and safely store.

• Build trust and minimize patient discomfort during phlebotomy procedures while efficiently collecting blood specimens.

Reporting to: Center Head / Principal Investigator / Co Investigator.

Participation in clinical trials:

Indication of Trial Phase Role in the trial

Critical Limb Ischemia IV Senior Clinical Research Associate Percutaneous Coronary Intervention

using optical coherence tomography

with angiography

IV Senior Clinical Research Associate

Type 2 Diabetes Management IV Senior Clinical Research Associate Hypertension IV Senior Clinical Research Associate Secondarily infected traumatic skin

lesion

III Senior Clinical Research Associate

Acne Vulgaris III Senior Clinical Research Associate Psoriasis lesions III Senior Clinical Research Associate Prostate Cancer II Senior Clinical Research Associate Ovarian Cancer II Clinical Research Associate

Atopic Eczema III Clinical Research Associate

Breast Cancer II Clinical Research Associate

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Localized pain III Clinical Research Associate

Parkinson's Disease II Clinical Trial Assistant

Breast Cancer II Clinical Trial Assistant

Rabies Vaccination III Clinical Trial Assistant

Asthma inhaler device II Clinical Trial Assistant

Bioavailability & Bioequivalence

studies – Healthy Volunteer trials

BA/BE

Clinical Research Nurse &

Coordinator

Training and Certification:

• Introduction to Clinical Research – The Global Health Network on 24/06/2019.

• ICH Good Clinical Practice E6 (R2) - The Global Health Network on 24/06/2019.

• Basic Life Support – St John’s Medical College & Hospital on 04/2018.

• ICH-GCP, Schedule Y & Good Documentation Practices – G7 Synergon Pvt Ltd on 02/08/2018.

• Blood Donation Programs – Karnataka Red Cross Society on 08/09/2018.

Personal Information

Date of Birth 12 May 1987

Gender Male

Status Single

Nationality Indian

Address No.384, 23

rd

main road, 2

nd

stage, BTM layout, Bangalore-

560076, Karnataka, India.

Hobbies & Interests Volunteer work at blood donation camp & health education.

Travelling (explore different culture, food).

Indoor & outdoor sports (table tennis, cricket, chess).

Job-related activities (attend conferences, programmes).

Art (drawing pencil sketch & water colours).

Date:

Place: Bengaluru (Murali B M)



Contact this candidate