Job Description

Job Id   MCCR213
Title   Clinical Research Associate (Home based)
Category   Clinical
Job Status   Full Time
Job Type   Permanent
No of Openings   1
Salary   Open
Region   Asia Pacific
Country   India
State   Gujarat
City   Ahmedabad
Zip   
Posted On   8/7/2014
Expires On   9/7/2014
Years of Experience   2-4 yrs
Contact Person   Rajesh. Neelam
Contact Email   rajesh.neelam@makrogrp.com
Contact Number   
Job Description   

Dear Candidate,



Greetings!!!

Currently we are hiring Clinical Research Associate (Home based) to work from our Ahmedabad location. Interested Candidates send your resume to rajesh.neelam@makrogrp.com


Job Title: ClinicalResearch Associate (Home based)

Location: Ahmedabad

No. ofOpenings: 1

Experience: 2-4 yrs

 

JobDescription:

  • Site identification, site qualification and investigator selection in compliance with sponsor protocol and ICH-GCP requirements.

•     To provide GCP training to the study staff.

•     Coordinating and organizing the studyinvestigator meetings, interim, coordinators meeting and its documentation(MOM).

•     Clinical trial monitoring visits,preparation and submission of monitoring report to the Team Lead- ClinicalOperations.

•     Verification of clinical trial documentswhich includes protocols, CRFs, ICF, and IRB documentation.

•     Ensure accuracy and completeness ofTMF/SMF, Investigator files, Subject medical files, Site register, and Subjectvisit logs.

•     Provide updated information to theinvestigator on investigational medicinal product (IMP).

•     Provide information to the Team Lead -Clinical Operations and Sponsors on the progress of clinical trial.

•     Verification of pharmacy records, drugdispensing and drug accountability records, study randomization plan as per thestudy protocol, ICH GCP, applicable regulatory requirements and governing SOPs.

•     Ensure that the environmental conditionsare maintained inside the pharmacy (i.e. Temperature logers, Humidity logers).

•     Ensure that all the data queries areaddressed to Team Lead - Clinical Operations, documented and resolved with inthe specified timelines.

•     Monitoring that investigator and studystaff adheres to good clinical practices, the study protocol and governingSOPs.

•     Ensure that the informed consent processand documentation is done in compliance ICH-GCP and applicable regulatoryrequirements.

•     Ensuring that all adverse events whichinclude non-serious adverse events, serious adverse and suspected unexpectedserious adverse reports (SUSAR) are properly documented and reported to theIRB/IEC and regulatory authorities.

•     To make regular contacts with the principleinvestigator or other site staff members during the course of the studies, toensure all is proceeding to agreed protocols and the time schedules and thatthe data is being recorded accurately returned to the required timescales.

•     To review all data produced from each studyand resolve any data queries/protocol deviations identified.

•     To conduct source data verifications asrequired to data monitoring guidelines.

•     Work with the safety officers to clarify,respond to, and resolve adverse events as they rise.

•     To ensure that data is provided to the datamanager in a timely manner for data basing.


AboutMakroCare:


Expert Strategic Development and Commercialization Global Partnerfor Pharmaceutical, Biotechnology and Medical Device industries. OurExperience, Programs and Processes bring a New Dimension to DevelopmentStrategy, Regulatory/Risk Planning & Management, Clinical Research,Medical/Scientific Support and Emerging Region Expansion


·        Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)

·        3-time FAST 500 in North America by Deloitte

·        3-time INC 5000 company

·        Best “Biotech Support” award for 2009 and 2011from US Commerce



Thanks,

Rajesh. Neelam