Invites for Clinical Research Associate (Home based) in MakroCare

Expert Strategic development and commercialization global partner for pharmaceutical, biotechnology and medical device industries. Our experience, programs and processes bring a new dimension to development strategy, regulatory/risk planning & management, clinical research, medical/scientific support and emerging region expansion.
MakroCare has operations and presence in US, UK, EU, and Asia. MakroCare is well positioned to meet the demands of the expanding product portfolio needs of our life sciences clients worldwide. We also understand the demands of an increasingly competitive market.

Post: Clinical Research Associate (Home based)

Job Description:
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 study investigator meetings, interim, coordinators meeting and its documentation(MOM).
• Clinical trial monitoring visits, preparation and submission of monitoring report to the Team Lead- Clinical Operations.
• 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 study and 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.

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

Additional Information:
Experience: 2-4 years
Location: Pune, Maharashtra
Job Id: MCCO213
Job Status: Full Time
Job Type: Permanent
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 07^th October, 2014