Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions. It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.
Post : Clinical Research Associate
Emoluments/ Duration : up to Rs. 35,000 per month, consolidated for 12 months
Location : Clinical Study Sites in Delhi/NCR
Job profile
• Conducts clinical monitoring through site visits (site assessment, preparedness, initiation, monitoring and close out visits)
• Conducts pre-study site visits, collects and reviews data, and prepares evaluation reports; participates in the final selection of investigators and study sites
• Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with SOPs, guidelines and policies
• Monitoring the clinical study and review on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, investigational product reconciliation and disposition, review of completeness and accuracy of IP accountability files, and retrieval of relevant documents, and provides remedial training and/or initiates corrective action as required
• Imparting training to site personnel for study conduct; participates and/or conducts site meetings and prepares reports
• Ensures appropriate transmission of CRF data to the data management unit; reviews case report form queries /problems, and clarifies and/or obtains changes to data as appropriate
• Prepares site visit reports, finalize with Quality Manager’s inputs and share with the relevant stakeholders for necessary corrective and preventive action
• Conducts site termination visit, in case required and submits a detailed report to the sponsor/ site
• Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools
• Setting up the study files as per the documentation practices agreed upon for the project and ensure compliance throughout study duration.
• Archiving study documents and study material as per plan.
• Escalate quality issues to Quality Manager
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
Bachelor’s degree in Lifesciences with Master’s /PG diploma in Lifesciences/clinical research or equivalent 3-4 years of relevant clinical trial and/or field monitoring experience with a recognized institute / organization (CRO, pharmaceutical, biotechnology company)
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Skills
• Good knowledge of GCP/GLP and appropriate clinical research regulations and guidelines, adverse medical event investigation, analysis, and reporting procedures and standards
• Strong written and verbal communication skills in English
• Detail-oriented approach
• Ability to develop and deliver presentations/trainings
• Good problem solving and negotiation skills to conduct vigilant and effective monitoring
• Ability to remain flexible as projects and priorities change
• Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Ability to travel extensively independently
• Familiarity with basic computer software: MS Word, E-mail, Excel, Internet
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified. Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Clinical Research Associate” (Zinc Sepsis Study)” to cdsa_admin@thsti.res.in. Application will be accepted upto 10th November 2017.
5. Only shortlisted candidates will be contacted for further discussion
6. Incomplete applications will stand summarily rejected without assigning any reasons.
7. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
8. This position is strictly project-based and hired only for 22 months.
9. All results will be published on our website and all future communications will be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
11. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad. 12. Canvassing in any form will be a disqualification.
Application will be accepted upto 10th November 2017.
Those who have applied earlier need not apply again.
Note: In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.
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