Professional Summary

Certifications

Skills

Work History

D. S D

** ******* ****** *** *******, Toronto, ON M6J 2K4 • Cell: +1-647-***-**** • ac4ksb@r.postjobfree.com www.linkedin.com/in/drshamikacra-91452822

A Certified Clinical Research Associate (by ACRP) & a medically qualified professional with over 2 years of experience in clinical research.

Managed clinical projects with specific focus on technical and operational coordination (of clinical studies) with study sites, external service providers and internal departments and support clinical trials by identifying potential investigators; conducting pre-trial site visits; training site staff; monitoring trial, drug accountability and other study related activities to ensure compliance with protocol and overall clinical objectives

Overall 6 years of work experience including clinical research, entrepreneurship and clinical dentistry.

Certified Clinical Research Associate - awarded by The Association Of Clinical Research Professionals

(ACRP)

A logical and an inquisitive mind

Excellent numerical, written & verbal

communication skills

Attention to detail

Meticulous at planning and diligent

at execution

Good people skills

Time management

Proficient in EDC, IWRS and

Remote monitoring systems

Proficient in MS-Office

Excellent analytical skills

Clinical Research Associate, 01/2016 to 10/2017

THINQ Pharma-CRO Limited – Thane, Maharashtra

Primary contact for the site; liaison with study teams. Site Identification & Feasibility: Identified potential qualified investigators and clinical sites as required, including contacting potential investigators and conducting pre-study site visits, assisting in collective review and tracking of essential pre-study documents as required Monitoring: Performed periodic on-site monitoring, remote monitoring and site close-outs as per ICH/GCP guidelines, Schedule Y, global and local standard operating procedures and monitoring plans.

Performed investigative site file reconciliation; managed any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance.

Performed source document verification, site file review, query resolution in a timely manner and oversaw drug accountability and safety at investigative sites. Ensured Serious Adverse Event (SAE) reporting according to project specifications. Responsible for resolution of site-specific issues and partnering with site to meet study milestones. Proactively drove and kept a track of subject recruitment Negotiated study budgets with investigators

Performed Investigator's meeting related tasks (scheduling, planning of the meeting and preparation of PowerPoint presentation)

Protocol & GCP Training: Provided training for protocol, trial–specific tools and systems, specialized procedures & GCP to sites during the Investigators' Meeting, Site Initiation visit and as required during the course of the trial

Provided regular clinical status information to team members and project manager Identified and communicated site and study trends during the course of the trial to Project Manager Participated in team discussions for identifying risks, finding suitable resolutions and modified the monitoring approach based on the identified risks under the direction of Project Manager Responsible for mentoring new CRAs and CTAs for their development and assisting to complete the training needs

Prepared newsletters

Was the central point of contact for sponsor's vendors and central labs for study specific communication

Tracked and processed investigator and vendor payments in accordance with THINQ policies, procedures and Standard Operating Procedures

Developed plans/processes and created tools to execute them for different phases of a clinical trial

(site identification, start-up, site monitoring)

Independently developed Trial Master File Plan and participated in development of Monitoring Plan and Project Management Plan

Submissions to Regulatory Agency and Ethics Committees: Compile and Review Trial Master File

(TMF), eTMF and Site Regulatory Binders

Prepared comprehensive and detailed project specific reports documenting study status, site issues and monitoring activities

Participated in departmental planning sessions and was responsible for SOP development under the Education

Other Work Experience

guidance of the Head of Department, Head of Quality Assurance and the Clinical Project Manager Clinical Trial Assistant, 07/2015 to 12/2015

THINQ Pharma-CRO Limited – Thane, Maharashtra

Assisted in drafting Investigators' Brochure, Protocol, Patient Information Sheet & Informed Consent Form, Source Document Template, Clinical Study Report & Manuscripts for publication Contributed and assisted in development and designing of Interactive Web Response System

(IWRS) and Remote Monitoring Systems

Played a vital role in compiling and reviewing the submissions to DCGI (regulatory in India)and the sites' Ethics Committees

Responsible for maintaining and updating Central Site Files; Trial Master File and eTMF. Responsible for maintaining up-to-date study trackers Analyzed documents that were received from sites, internal departments and external vendors for accuracy, appropriate distribution and filing.

Supported Project Manager with daily operational functions. Bachelor of Dental Surgery: Dentistry, 2008

Maharashtra University of Health Sciences - Pune

Entrepreneur (Clinic Owner) – Mumbai, Maharashtra [07/2013 to 05/2015] Head Dentist at MyDentist (Total Dental Care Pvt Ltd.) – Mumbai, Maharashtra [10/2012 to 06/2013] Associate Dentist at Smiles Forever Dental Clinic – Mumbai, Maharashtra [06/2011 to 10/2012 ]

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