Work as Research associate in Synapse Labs

Synapse Labs is a Contract Research Organization (CRO) which offers a range of services to the Pharmaceutical and Biotechnology industry. We are dedicated to quality service, with focus on reducing time and cost, We are achieving this by understanding client requirement and working close with them to match their timeline.

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