Recruitment for Study Monitor at Clinical Development Services Agency | Emoluments upto Rs.40,000 pm
Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : STUDY MONITOR (PTB)
Emoluments : (Upto Rs.40,000 per month, consolidated) Project-based position on contractual basis for 12 months.
Qualifications and Experience
Bachelor's degree in healthcare or other related discipline or equivalent combination of education, training and experience or diploma/post graduate degree in Clinical Research with at least 2 years of relevant experience.
- Basic knowledge of applicable clinical research regulatory requirements; i.e., Indian-GCP, Schedule-Y and ICH-GCP guidelines
- Effective communication skills
- Good computer skills (MS Word, Excel, e-mail, etc)
• Perform site initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
• Administer protocol and study-related 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 to Project Manager.
• Manage 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.
• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other study-related documentation.
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
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