Work as Research associate in Synapse Labs
Post: Research associate
Job Description:
• Study in charge, which includes Planning and presentation of clinical research study information, Obtaining Informed Consent, Supervision of study related activities and Clinical data review (Compliance with Protocol, GCP).
• Execute the studies as per protocol, SOPs, GCP and other regulatory requirements.
• Preparation and Review of SOP’s according to the Regulatory requirements.
• Presentation of Informed Consent form to the volunteers / study subjects.
• Verifying the documentation of the Informed Consent form for each study subject.
• Monitoring of dosing, food consumption, volunteer interaction, documentation.
• Coordinating for the designing and preparation of Clinical Study reports, Protocols and summary reports as per regulatory requirements.
• Communication of Study Updates with Investigators, Sponsor and Project management.
• Co ordination with all concerned departments for proper planning & execution of studies.
• Checking the correctness, completeness, authenticity of the CRFs; recommending the required corrective actions as and when required.
• Preparation of all pre-study, during study & post-study documents related to study execution, making them ready for monitoring & audits.
• Query resolution management of the audits related to clinical aspects and other issues in coordination with quality assurance department.
• Responsible for communication of deviations with respect to the protocol, SOP’s, GCP and the applicable regulatory requirements to the investigator for taking corrective and preventive actions.
Candidate Profile
B.Sc/B.Pharm/M.Sc/M.Pharm with 2 - 3 years of relevant experience in CRO / Pharmaceutical Company.
Additional Information:
Experience: 2-3 years
Location: Pune
Education: B.Sc, B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: RnD
Email your resume, careers@synapselabs.com
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