- Overall day-to-day scientific and operational management of the trial, including:

- Screening of ICU admissions against Sepsis-3 eligibility criteria and maintenance of the screening and enrolment log.

- Coordinating the informed consent process with the investigators, including consent from legally authorized representatives and re-consent on recovery of capacity

- Implementing randomization and allocation concealment procedures (sequentially numbered opaque sealed envelopes) and safeguarding allocation records.

- Supervising administration of the study intervention per protocol and monitoring protocol adherence and deviations.

- Coordinating advanced hemodynamic monitoring (cardiac output, SVR, stroke volume variation), serial ABG/lactate sampling and biomarker (IL-6, procalcitonin) collection, storage and assay scheduling with the laboratory.

- Supervising the work of the Project Technical Support-III staff and ensuring complete, accurate and timely CRF completion.

- Database design and management, data quality control, periodic data audits, query resolution and preparation of the final cleaned dataset.

- Coordinating statistical analysis with the study statistician and assisting in interpretation of results.

- Recording, documenting and reporting adverse events and responsible adverse events to the PI and the Institutional Ethics Committee; maintaining pharmacovigilance and safety records.

- Maintaining regulatory and ethics documentation, CTRI registration and updates, SOPs and the trial master file; preparing progress, utilization and interim reports for ICMR.





- Assisting in training of investigators and ICU staff on protocol and data collection procedures.

- Assisting in preparation of manuscripts, conference presentations and the final project report.

- Any other scientific or administrative task assigned by the Principal Investigator in connection with the project.

Eligibility Criteria

Preferred Qualifications:

Essential:

- First Class post-graduate degree, including an integrated post-graduate degree, in Life Sciences / Biotechnology / Microbiology / Biochemistry / Pharmacology / Clinical Research / Public Health or an allied discipline from a recognized university; OR

- Second Class post-graduate degree, including an integrated post-graduate degree, with a Doctorate degree (Ph.D.) in a relevant subject from a recognized university.

Desirable:

- Ph.D. or M.Phil. in a relevant subject; or a post-graduate qualification in clinical research / clinical epidemiology.

- GCP (Good Clinical Practice) and ICMR National Ethical Guidelines certification.

- Working knowledge of biostatistics and statistical software (SPSS / R / STATA) and of electronic data capture systems (REDCap or equivalent).

- Prior publications in peer-reviewed journals

Age Limit: 35 Years

Preferred Language: English

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📌 Project Research Scientist -I (Non Medical) (Bengaluru)
🏢 St Johns Research Institute Sjri
📍 Bengaluru