Dr. Reddy’s Job Recruitment 2023 – Clinical Research Specialist Posts – Clinical Research Specialist Jobs Remote

Clinical Research Specialist Version 

 Plan and conduct Investigator’s Meeting
 Lead & guide data query resolutions
 Ensure timely reporting of SAEs, SUSARs to regulatory authorities and reporting of SAEs to all sites and investigators.

Systems & processes:
 Establishment & execution of procedures to ensure adherence to GCP, trial protocols, applicable regulations and administrative requirements.
 Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.

Stakeholder management:
 Act as the point of contact for all external and internal agencies
 Coordination with investigator and sites for executing clinical study agreements & financial agreements.
 Coordinate with internal stakeholders (Medical, Regulatory, QA etc.) for timely regulatory submissions

 Preferably 3 to 4 years working experience in the clinical operations department of a CRO/Pharma/Biotech organization
 Must have experience in handling large clinical trials with multiple sites for different therapeutic areas
 Must have experience in handling audits & inspections
 Training in clinical trial methodologies, research design and ICH – GCP