Multiple Posts vacant @ Quintiles || Life Science Freshers can apply - For Mumbai, Ahemdabad & DELHI NCR - CLINI INDIA CANDIDATES MUST APPLY, Referral will be provided "D"

Job Title: Clinical Research Associate ( CRA) -1 / CRA 2 / Sr CRA

Job Description

• Responsible for site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to Clinical Team Lead and/or Line Manager
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
• Create and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Provide training and assistance to more junior clinical staff.

1. Qualification: B.Sc / M.Sc Life Sciences
2. Experience: 0-2 years

Desired skills

• Should have computer skills including use of a laptop computer, knowledge of Microsoft Word, Excel and PowerPoint preferred.
• Basic knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Strong written and verbal communication skills including good command of English required.
• Excellent organizational and problem solving skills.
• Effective time management skills and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Training as Clinical Research Associate in Quintiles as per Quintiles India Clinical Operations Training policy or equivalent work experience in the CRO/pharmaceutical industry

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