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Senior Clinical Research Associate 1


Source:
TIMESJOBS.COM
Location:
Bengaluru, KA
Date:
07-11-2016
Job Code:
58220273
Categories:
  • Biotechnology & Science
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Job Details

At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the worlds largest provider of product development and integrated healthcare services. As one of FORTUNE s Most Admired Companies in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health PURPOSEPerform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Senior Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.RESPONSIBILITIESPerform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.Administer protocol and related study training to assigned sites and establish 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 as appropriateManage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.Act as a mentor for clinical staff including conducting co-monitoring and training visits.May provide assistance with design of study tools, documents and processes.Convey features and opportunities of study to site.Collaborate and liaise with study team members for project execution support as appropriate.
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 3-7

Requirements

Basic Research | Bio-Technology Research | Clinical Research | Quality Assurance/ Control
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