Clinical Research Data Analyst

Rajashri Varpe (MBBS, MS, CRM)

Advanced drug safety and pharmacovigilance course

Email: ********.*****@*****.***

Phone: 480-***-****

Summary:

Extensive experienced data analyst with a master’s in clinical research management (MS, CRM) and certified in Advanced drug safety and pharmacovigilance course.

Expertise in reviewing of data management project documents and their specifications like Case Report Form (CRF), Data management plan (DMP), eCRF Completion Guidelines (eCCGs), Data Validation Manual (DVM).

Performed data management activities in support of clinical and/or non-clinical research studies including pre-entry review, query management, database setup and quality control of the data and project.

Experience in entering adverse events data from individual case safety reports and proficient using biostatistics software, SPSS.

Successfully manages regulatory documents and clinical trial manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts.

Key Skills

Hand on experience on Oracle Argus safety and Trackwise (TW) from case booking to case processing.

Detailed information about human subject research.

Basic knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development.

Completed certifications about Bioethics, Bio specimen research and Human subject protection.

Prepared clinical research study protocols as a thesis projects during master’s in clinical research management.

Proficient using biostatistics software, SPSS

Good knowledge of GCP, IRB, FDA, SOP, AE, SAE, CRF, ICH, IND, and CRF guidelines.

Quick and fast learner, adaptable to new work environment, and ability to prioritize task.

Resourceful team-player with excellent interpersonal skills and an ability to build rapport with diverse groups.

Professional and possess a high degree of urgency and self-motivation and have a strong work ethics.

Possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other sensitive information.

Education:

Advanced drug safety and pharmacovigilance course, Sollers Institute, NJ

Master’s in clinical research management (MS, CRM), Arizona State University, Downtown Phoenix

Bachelor of Medicine and Bachelor of Surgery (MBBS), Byramjee Jeejeebhoy Medical College, Pune India

Other Courses/ Certifications:

Advanced drug safety and pharmacovigilance course

NIH Certificate of Completion of Protecting Human Research Participants

CITI Certificate Biomedical Responsible Conduct of Research

CITI Certificate Code of Ethical Business Conduct Training Curriculum

Completion Report

CITI Conflicts of Interest Curriculum Completion Report

CITI Certificate Biomedical Research Investigators and key personnel Basic

Course

CITI IRB Responsible Conduct of Research Undergraduate RCR training

CITI IRB Social and Behavioral Research Investigators and key personnel

training

CITI GCP training

IATA training

Medidata/RAVE certified

OSHA Blood borne Pathogen training

Medical terminology

Phlebotomy courses

CPR

First Aid

AED

Professional Experience:

Becton Dickinson (Tempe, Arizona)

March 2019 - Present

Field Assurance Specialist/Literature Reviewer

Responsibilities:

Strong experience of reviewing literatures for all BD devices for adverse event reporting and enter it into database. Analyze and summarize the biomedical case reports, studies, and reports.

Experience of post market studies, surveillance (PMS) and post market clinical follow up (PMCF) with literature review and reporting adverse vent to the FDA after the device released in the market.

Experience with medical record review.

Experience with Quality Control Review of medical device reporting files.

Evaluate, investigate, track and complete complaints (Class III implantable devices) through effective and established complaint handling processes.

Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.

Participate and collaborate objectively with team members to achieve consistent processes while identifying process improvements to drive efficiency and compliance.

Coordinate with team members in obtaining any missing information.

Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.

Review each complaint and determine eligibility for adverse event reporting to worldwide regulatory agencies.

Experience with Master Control and Trackwise, quality review of medical device reporting according to good manufacturing practice.

Familiar with regulatory guidance such as ISO 13485, 21 CFR 820.30

Professional experience working with quality assurance or FDA regulations.

Investigate and report Serious Adverse Events (SAE) and the post-market adverse event reporting in US, Canada, Australia and other International Countries; final review all reports for submission to regulatory agencies.

Acknowledges receipt of complaint and generates closure letters, as appropriate.

Assists with complaint reportability determinations (e.g., MDR, Vigilance, etc.).

Provides information necessary for completion of regulatory reports (e.g., MDR, Vigilance, etc.).

Assures timely complaint closure, meeting both internal and external requirements and goals, by tracking complaints and samples from the customer thru file closure.

Continuously monitors complaints for potential trends.

Responsible for the secure and accurate maintenance of the complaint database.

After receiving new information, send supplemental and electronic MDR to the regulatory authority (FDA).

Reviewing complaints for quality assurance and field assurance, inform the appropriate field assurance specialist for any updates and then close the complaints.

Statistics and Data Corporations (Tempe, Arizona)

Mar 2018 – Oct 2018

Clinical Data Analyst

Responsibilities:

Under supervision, performs data management activities in support of clinical and/or non-clinical research studies including pre-entry review, query management, database setup and quality control of the data and project deliverable.

Apply protocol specific knowledge to execute the tasks assigned within the project.

Perform data entry, query management including review, creation and resolution.

Participate in internal and external team meetings, as necessary.

Assist in database setup including document creation and review, data entry screen and edit check testing and review, etc., as necessary.

Maintain quality control of the data, project deliverable and closeouts, source and regulatory documents.

Assist in reviewing medical coding for validity and completeness, as needed

Perform SAE reconciliation, lab reconciliation and database validation.

Trial Master File (TMF) creation and maintenance for quality check and audits.

Review of data management project documents and their specifications like Case Report Form (CRF), Data management plan (DMP), eCRF Completion Guidelines (eCCGs), Data Validation Manual (DVM)….

Effectively work within EDC (iMedNet) database.

Sollers Institute (New Jersey)

Dec 2016 – May 2017

Advanced Drug Safety and pharmacovigilance

Drug safety Intern

Responsibilities:

Accurately enter adverse events data from individual case safety reports from both investigational and post marketing products.

Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.

Basic working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports.

Understanding of medical terminology and the ability to summarize medical information.

Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.

Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies.

Updated and entered appropriate data into Clinical safety database and ensured data was captured according to the verbatim.

Hand on experience in Oracle Argus 8 version and Empirica.

Process case using MedDRA version 18 and have experience with MedDRA coding.

Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA.

Wrote narratives summarizing the events according to departmental SOPs for spontaneous and literature cases through assessment of all source documents.

Reviewed, processed, coded, and submitted serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines.

Prepared narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases.

Working knowledge of MDR MedWatch, Medical Device Directive, and FDA

Quality System Regulations

Carl T Hayden VA Medical Research Foundation Center (Phoenix, Arizona)

May 2016 – March 2017

Research Assistant/Coordinator

Responsibilities:

Recruit, screen, and consented patient.

Managed regulatory documents and clinical trials manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts.

Facilitated the completion of clinical charts and case report forms.

Controlled quality of data retrieved from hospital records and reported research activities to team.

Implemented recruitment strategies to get PI's more involved with subject enrollment.

Identified problems and/ or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events.

Verifies that patient have completed all appropriate registration material and related records and information.

Maintained accurate records of Adverse Events, expedited reports of Serious Adverse Events.

Arizona State University (Phoenix, Arizona)

Master’s in clinical research management

August 2010 – December 2013

Mimer Medical College (Pune, India)

January 2005 – May 2007

Pathology and Microbiology consultant

D.Y. Medical College (Pune, India)

June 2003 - December 2004

Surgery Resident

Sassoon General Hospital (Pune, India)

May 2002 – May 2003

Doctor internship

B. J. Medical College (Pune, India)

Bachelor of Medicine and Bachelor of Surgery (MBBS)

June 1997 – April 2002

Contact this candidate