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Clinical Research Associate Job Vacancy at MS Clinical Research
Clinical Research Associate (CRA) at MS Clinical Research
Job Title: Clinical Research Associate (CRA)
Location: Bangalore, Indiranagar
Salary: Up to ₹6 LPA
Experience: 2–4 years
Qualification: Bachelor’s or Master’s degree in Life Sciences, Medicine, or a science-related field.
Interview mode: Remote / Virtual Interview Mode
Key Responsibilities
- Monitor clinical trial sites through initiation, monitoring, and close‐out visits to ensure adherence to study protocols, ICH‐GCP, and regulatory standards.
- Conduct source data verification (SDV) by reviewing Case Report Forms (CRFs) and matching against source documents to maintain data integrity.
- Review regulatory documents (e.g. informed consent forms, ethics approvals, investigator files), and ensure compliance with local and international guidelines.
- Manage site-related logistics including selection, initiation, training, IP handling, and close-out activities.
- Prepare detailed monitoring visit reports, follow-up letters, and action plans; maintain the Trial Master File and Investigator Site File.
- Identify non‐compliances or deviations and implement risk mitigation plans in coordination with site staff and project teams.
- Communicate and collaborate with investigators, site coordinators, sponsors, and regulatory teams to ensure seamless trial conduct.
- Provide training and guidance to site personnel regarding protocol requirements, GCP, and data handling processes.
Eligibility & Required Skills
- Bachelor’s degree in Life Sciences, Medicine, or related field.
- 2–4 years of experience working as a CRA within a pharmaceutical company or CRO, including site monitoring and regulatory compliance.
- Strong knowledge of GCP, ICH guidelines, and applicable local/international regulatory frameworks.
- Experience with source data verification, CRF review, and monitoring visit reporting.
- Excellent communication, interpersonal, and organizational skills to interact effectively with site staff and sponsors.
- Proficiency in Microsoft Office, clinical trial management systems (CTMS), and electronic data capture (EDC) platforms.
- Ability and willingness to travel to clinical trial sites, sometimes with short notice.
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