Scribd
Upload
19 views

Skills: Microsoft, Tableau, Octalsoft, Imedidata

Uploaded by

cr.indoremitcon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
19 views

Skills: Microsoft, Tableau, Octalsoft, Imedidata

Uploaded by

cr.indoremitcon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

XYZ

Pune | [email protected] | +91 12456 | www.linkedin.com/xyznak

Experienced Clinical Research Quality Associate and Ethics Committee Professional with a
demonstrated history of successfully managed clinical trials and studies pertaining to Biomedical and
Pharmaceuticals drugs, Medical devices and Vaccine.
Experience Handling of 20+ Clinical trials and managing Phase I, II, III, IV and Nutritional Clinical
Studies in Multiple therapeutic areas like General Medicine, Oncology, Endocrinology and Respiratory
Diseases.

SKILLS
_________________________________________________________________________________

Clinical Research: EC Submission, Coordinate with CRA and Site team and EC Chairperson,
Protocol adherence, Patients Recruitment, Informed Consent, Source Documents Verification, Data
Collection, Maintain TMF and SMF, Achieve Recruitment goal as per project Plan.

Clinical Trial Management: Site start-up/site engagement, site feasibility, patient recruitment,
site coordination, Quality management, e-CRF monitoring for oracle, Clindox, Conslix
TMF and ISF management in Veeva vault and paper TMF and ISF.

Soft Skills: Effective Communication, Task Prioritization, Team and Site management, Problem
Solving, Resolution, Smooth conduction of trial related activities.

Software Skills: Microsoft, Tableau, Octalsoft, iMediData.

Management: Mentoring skills, Cross Collaboration between teams.

EXPERIENCE
_________________________________________________________________________________

XyzPVT. LTD PUNE, INDIA


Quality Associate & Ethics Committee Coordinator Feb 2023 to Nov 2023

 To ensure CRFs are valid representation of the subjects during their participation in a study.
 Ensuring timely submission and reviewing CRF data & query resolution as per timelines set forth
in the SQMP; ensure issues of data quality are escalated and resolved/followed-up with the study
team.
 Conducted QA 32 Audits for Site, and faced 2 Sponsor Audits.
 Facilitated the ethical review process for research proposals, ensuring compliance with
institutional and regulatory guidelines.
 Collaborated with research’s, sponsors and regulatory agencies to address queries and provide
guidance on ethical considerations.
 Track protocol deviations/violations, timelines and all study-related tasks.
 Ensure timely and accurate receipt and dispatch of drug and non-drug clinical supplies to sites.
 Providing administrative and data support to clinical teams by assisting project teams in the
completion of assigned project activities.
 Guiding clinic staff for resolution of queries and preparing CRF validation checks.
 Leading AE / SAE monitoring.
 Responding to project related communications proactively and timely.
 Managed the documentation and record-keeping process related to research proposals,
approvals and committee decisions.
 Worked on Phase: I, II, III, IV and Nutritional Clinical Studies in Multiple therapeutic areas like
General Medicine, Oncology, Endocrinology and Respiratory Diseases.

Xuz CLINICAL DEVELOPMENT CENTRE PVT. LTD PUNE, INDIA


Intern Clinical Research Coordinator Nov 2022 to Feb 2023

 Manages site compliance with research protocols by reviewing all regulatory requirements to
confirm implementation of appropriate methods, practices and procedures of all research
activities.
 Interfaces with research participants to support efforts to determine eligibility and consenting of
study participants according to protocol.
 Develop accurate and timely material and ensuring compliance from site staff.

EDUCATION
_________________________________________________________________________________

MBA – HOSPITAL AND HEALTHCARE MUMBAI, INDIA


D. Y Patil University Jan 2023 to Ongoing

PG CERTIFICATE COURSE IN CLINICAL RESEARCH PUNE, INDIA


JxyZir Centre for Learning May 2022 to Oct 2022

BACHELOR IN SCIENCE (ZOOLOGY) RATNAGIRI, INDIA


Mumbai University June 2019 to June 2022

TRAININGS & WORKSHOPS ATTENDED


_________________________________________________________________________________
● ICH-GCP training and IWRS site staff training.

● Workshop on Good Clinical Practice (GCP) by Indian Society of Clinical Research (ISCR).

● Ethics Review of Health Research (NIE-ICMR e-Certificate Course: NIeCer 102) By ICMR.

ADDITIONAL INFORMATION
_________________________________________________________________________________

● Awarded with Cambridge English Entry Level Certificate in ESOL International (Entry 3)
Preliminary).

● Participated in National Camp of Ek Bharat Shreshta Bharat of National Cadet Corps.

● Passed National Cadet Corps ‘C’ Certificate Examination with B Grade.


● Awarded with ‘A’ grade in Intermediated Drawing Grade Examination by Government Of
Maharashtra.
● Read over 40+ books including autobiography, Fiction, Mystery, Nonfiction, Historical.

______________________

You might also like