A leading global CRO, PRA is transforming clinical trials through our people, innovation and transparency. We serve clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge
PRA’s commitment to excellent in research begins with our people. Our workforce has grown by over 25% since 2010 and now comprises over 4,700 employees spanning more than 13 time zones and speaking more than 15 languages.
Post: Clinical Research Associate
Job Overview
The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Job Description:
- Applies knowledge of PRA’s policies and procedures
- Demonstrates excellent written and oral communication
- Demonstrates excellent knowledge of ICH/GCP
- Displays ability to manage investigative sites to facilitate trial deliverables
- Demonstrates ability to escalate issues appropriately
- Conducts monitoring to confirm subject safety and data ntegrity
- Describes and demonstrates the principals of IP accountability
- Identifies scientific misconduct at the site level
- Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
- Mentors CRAs new to the position or company Serves as an observation visit leader
- Conducts monitoring evaluation visits
- Assists team lead in the development of trial tools or documents
Candidate Profile :
• Read, write and speak fluent English; fluent in host country language required.
• 2+ years of clinical monitoring experience required
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Clinical research experience
• Knowledge of ICH and local regulatory authority regulations regarding drug
• An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
• Experience in monitoring all trial components (PSSV to COV)
• Experience in coaching/mentoring other CRAs
Additional Information:
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CRA
End Date: 15th December, 2017
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