Clinical Research Data

Resume

Full Name : Rimple B Shah

Job Title : Clinical Research Scientist

Department : Research and Innovation

Company : Datar Cancer Genetics Limited - Nashik

Function : Clinical Data Management

PROFESSIONAL EXPERIENCE:

1) Organization: Datar Cancer Genetics Limited

Designation: Clinical Research Scientist

Duration: 04 Jun 18 to till date

Job Responsibilities:

Enrollment of patients.

To coordinate TR (Therapy Recommendation) for cancer patients with respective hospital.

Patient Counselling

Coordination of patients visit, blood collection etc procedures as per study protocol.

Collecting data and manage them in respective format. 2) Organization: Karmic Lifesciences LLP, Ahmedabad Designation: CDA

Duration: 09 Jan 17 to 30 Nov 2017

Job Responsibilities:

Creation, maintanation, and updation of study related documents such as Data Management Plan, Data Validation Plan and Study Specific Procedures etc.

Designing Case Report Forms for paper and EDC studies and reviewing CRFs design

Perform data entry in the database whenever required.

Conduct regular meetings with the study team, tracking and managing the study, oversee study progress, ensure quality on deliverables

Identify and resolve data discrepancies in clinical data via computerized and manual data checks, apply level 1 correction as required

Perform the Quality Review of live data.

External Data handling, SAE Reconciliation, Lab Reconciliation, proactively identify and manage resource needs to timelines and task, perform medical coding. 3) Organization: Medilink Hospital Research Center Designation: CRC

Duration: 2 years

Job Responsibilities:

Subject screening, enrollment, randomization, documentation, follow-up of subjects which includes subject retention strategy.

Overall handling of Clinical Trial activities, in process experience of more than 7 clinical trials, auditing and monitoring process, understanding of end to end clinical trial processes and operations.

Communication with site manager, sponsor, ethics committee, investigator.

To ensure study specific requirements and central lab related requirements at site.

Archiving of study documents, Prepare Ethics committee dossier, Communicate with ethics committee.

4) Organization: Bankers Heart Institute

Designation: CRC

Duration: 6 months

Job Responsibilities:

Subject screening, enrollment, randomization, documentation, follow-up of subjects.

Updation of Documents of Ongoing Studies.

To ensure study specific requirements and central lab related requirements at site.

IP Management and Temperature Control.

EDUCATIONAL QUALIFICATION:

Qualification: PGDCM

Institute: Mojidra Institute of Clinical Research

Duration: 2013-2014

Qualification: Bpharm

University: Gujarat Technological University

Duration: 2009-2013

PERSONAL DETAILS:

Gender: Female

Date of Birth: 24-Feb-1992

Contact Details: 942-***-****

Languages known: English, Hindi, Gujarati.

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