Strand Life Sciences Freshers PhD Clinical Research Scientist Job – Apply Online

Strand Life Sciences

Clinical Research Scientist

Bengaluru, Karnataka, India

About the job

We are looking for an experienced Clinical Research Scientist who can be part of the clinical research team contributing to existing and upcoming clinical research projects and trials, working with the team for timely execution of the clinical projects.

Job Responsibilities

The Clinical Research Associate/Scientist will be responsible for:

● Scoping

• Help the team in rapid and accurate feasibility analysis of upcoming projects. Example projects are in the areas of Oncology, Reproductive Health, Metabolic Disorders, and Neurodegenerative Diseases, often involving some genomics component to the study design.
• Engage with investigators across the country and get reasonably accurate estimates of recruitment rates, often for difficult indications.

● Planning and Setup

• Contribute to planning and setting up new clinical studies, including drafting/refining study-related documents and EC dossiers.
• Identify candidate sites and engage with PIs and site CRCs to assess feasibility for shortlisting sites.
• Negotiate with sites to draft agreements for engagement.
• Put together necessary documentation for EC submissions and assist site teams as needed to ensure timely EC approvals.
• Perform regular quality control (QC) checks on clinical data received, ensuring accuracy, consistency, and completeness.
• Plan the setup of other systems and processes for smooth trial execution, including IVRS/IWRS, EDC for electronic CRFs, study documents, ISF, and site initiation activities.
• Prepare documentation for regulatory compliance submissions like DCGI/CTRI/HMSC.
• Manage vendors, contracts, sourcing, budgeting, and meticulous project planning for smooth study execution.

● Implementation & Execution

• Implement processes for efficient clinical trial execution.
• Train site staff and conduct site initiation activities.
• Ensure diligent data collection, validation, and monitoring for each study, site, and subject.
• Troubleshoot recruitment issues using innovative strategies like OPD patient screening, referral networks, and investigator collaboration.
• Ensure adherence to GCP guidelines for ethical and high-quality clinical studies.
• Handle and report SAEs, process medical expense payments, and maintain records for audits.
• Track study progress, identify challenges, record issues, and discuss solutions in internal and customer meetings.
• Manage project costs and timelines per the original proposal.
• Ensure SOPs for clinical studies are up to date and studies are conducted accordingly.
• Train new team members, maintain documentation for sponsor audits and regulatory inspections, and ensure diligent study record-keeping.

Candidate’s Requirements

• Ph.D. in Life Sciences (MUST), fresher or with 1-2 years of experience in oncology or clinical trials management.
• Ability to manage multiple trials simultaneously and meet deadlines.
• Clinical Data Management experience, preferably in a CRO team across multiple therapeutic areas, is an advantage.
• Strong understanding of clinical trial methodology, GCP (Good Clinical Practice), GDMP (Good Clinical Data Management Practice), and medical terminology.
• Knowledge of clinical guidelines such as NDCT (New Drugs and Clinical Trials) Rules, ICMR Guidelines, and DCA (Drugs and Cosmetics Act) is desirable.
• Strong organizational skills for extensive documentation and computerized clinical trial management.
• High attention to detail with an analytical mindset.
• Proficiency in English, Kannada, and Tamil.
• Experience in multicultural and multidisciplinary environments.
• Dynamic team player with excellent communication, networking skills, flexibility, and scientific curiosity.
• Willingness to travel (50% of job requires travel, with extended site stays as needed).

What Strand Life Sciences Offers

• Exciting opportunities for professional growth and development.
• Vibrant multidisciplinary scientific interaction and learning opportunities.
• A collaborative, solution-oriented work environment where innovation is encouraged.
• Exposure to translational research involving cutting-edge genomics studies.
• An open and innovative culture in a multicultural environment.
• Competitive salary and generous social benefits.

APPLY ONLINE HERE

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