Clinical Development Services Agency (CDSA) mission is to create, develop, nurture world class clinical product development capacity in India.
CDSA invites applications from high performing professionals with a desire to serve public health needs of the country for the below mentioned administrative position
Post : Study Monitor (INVICTUS Study)
Emoluments / duration : Maximum up to Rs 50,000/- per month for 6 months
Location : CDSA Office, Faridabad
Job profile
* Managing all operational aspects for implementation of clinical trial activities for study start-up and initiation, ensuring compliance with GCP and applicable guidance.
* Dedicated resource responsible for the establishment of quality management system, operational documents, site preparation & initiation.
* Coordinating with sites for site assessment, IEC submissions/approvals and site initiation.
* To plan and oversee the study start-up activities for the project across the sites
* Facilitate initial training to research team on interpretation of GCP/ethical requirements.
* Conducts pre-study site visits for site assessment, preparedness and initiation, collects and reviews data, and prepares evaluation/site visit reports
* To identify significant problems and issues at sites and their rectification.
* Coordinates for training of site personnel on sponsor and regulatory requirements for study conduct
* Coordination for Ethics committee submission and approvals at all the sites * To coordinate and communicate through telecoms/ skype or remote access with the sponsor/coordinating site
* Escalate quality issues to the Project Manager/sponsor/respective PIs
* Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
1. Bachelor’s degree in life sciences/biomedical sciences / pharmacy with PG degree or Diploma in Life sciences/Pharmacy/Management / Clinical research.
2. Minimum 3 years of relevant clinical trial and field monitoring experience with a recognized institute / organization (CRO, pharmaceutical, biotechnology, or device company)
3. Strong written and verbal communication skills in English
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Skills
* 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, Email, 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.
5. 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 “Study Monitor (INVICTUS Study)” to cdsa_admin@thsti.res.in.
6. Only shortlisted candidates will be contacted for further discussion
7. Incomplete applications will stand summarily rejected without assigning any reasons.
8. 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.
9. This position is strictly project-based and hired only for the project duration
10. All results will be published on our website and all future communications will be only through email
11. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
12. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
13. Canvassing in any form will be a disqualification.
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.
CLINICIAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of Translational Health Science & Technology Institute
(an autonomous institute under the Department of Biotechnology (DBT),
Ministry of Science & Technology, Govt. of India)
NCR Biotech Science Cluster at Gurgaon-Faridabad Expressway, Faridabad.
Recruitment Notice No . CDS/RN/INVC/17/2017
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