CDSA looking for M.Pharm, M.Sc as Clinical Research Associate | Emoluments Up to Rs.55,000/- pm

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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 : Clinical Research Associate

Program : NBM Program

Emoluments : Upto Rs. 55,000/- per month consolidated

Duration : One year

Location : CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad

Job profile
He/ She will plan and conduct clinical monitoring activities for the clinical trials/ studies that are assigned to CDSA through the consultancy grant from NBM. CRA will ensure that the studies are conducted in accordance with study protocol, standard operating procedures, good clinical practices, and applicable guidelines

• He/she will perform site monitoring activities during assigned study start-up, initiation, conduct and closeout, in accordance with contracted scope of work
• Perform site monitoring throughout the trial which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work
• Perform quality functions and execute quality programs (clinical operations, clinical laboratory) as per GCP and regulations
• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Ensure setting up the assigned trial sites as per protocol and applicable requirements.
• Ensure protocol and related trial training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Support NBM-PMU for appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required trial documentation.
• Manage the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
• Verify that data entered on to the CRFs is consistent with participant clinical notes (source data/ document verification)
• Review filing and collating of trial documents and reports.
• Evaluate the quality and integrity of trial site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to the Project lead/NBM designee and/ or senior management
• Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required
.

Qualifications and Experience
• Bachelor’s in life sciences with 5 years of relevant clinical trial monitoring experience
• Bachelor’s in life sciences and Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline with 2 years of relevant clinical trial monitoring experience
.

Skills
• Computer skills including proficiency in use of Microsoft Office applications
• Basic knowledge and ability to apply GCP 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

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