Project Technical Support -III - ICMR BLUE SHOCK Trail Project

St Johns Research Institute (SJRI); Bengaluru; On-site; INR 550,000 - 750,000; Full time

Job summary

St Johns Research Institute (SJRI) in Bengaluru seeks a Biomedical Data/Trial Support role to assist bedside and technical aspects of ICU trial conduct. You will screen ICU admissions for septic shock, identify eligible patients within 24 hours, and support informed consent and documentation.

You will collect clinical and laboratory data, operate ICU monitoring devices, and ensure timely data entry and sample handling for biomarker analyses, with follow-up through day 28.

Qualifications

• Graduate degree with 3 years of relevant experience in science/health fields or postgraduate degree in related subject.
• Training in Good Clinical Practice is desirable.
• Experience with phlebotomy, sample processing or ICU monitoring equipment is a plus.

Responsibilities

• Daily screening of ICU admissions for septic shock and identifying eligible patients within 24-hour enrolment window.
• Assist investigators with informed consent and maintenance of consent documentation.
• Prospective bedside collection of clinical, hemodynamic and laboratory data at predefined time points.
• Operate and assist with cardiac output monitoring devices per protocols and escalate faults.
• Collect, label, process, store and transport blood samples for biomarker and routine analyses; liaise with central lab.
• Complete case record forms and data entry into the study database; resolve data queries.
• Follow-up enrolled participants for outcome data up to day 28, including telephonic contact.
• Maintain study logs, drug accountability records, and sample inventories.
• Report adverse events promptly to Project Research Scientist-I and Principal Investigator.
• Assist in study documentation, filing and audit preparation.

Skills

Data entry

ICU data collection

Education

Bachelor's degree in Science / Life Sciences / Nursing / Medical Laboratory Technology / Allied Health Sciences

Post-graduate degree in Life Sciences / Microbiology / Biochemistry / Biotechnology / Clinical Research / Allied Health Sciences

Tools

MS Excel

REDCap or equivalent

Job description

Bedside and technical support for trial conduct across the Medical and Surgical ICUs, including:

• Daily screening of ICU admissions for septic shock and assistance in identifying eligible patients within the 24-hour enrolment window.
• Assisting the investigators in the informed consent process and in maintaining consent documentation.
• Prospective bedside collection of clinical, hemodynamic and laboratory data at the predefined time points - vasopressor doses, MAP, cardiac output and SVR, lactate, ABG and organ-support parameters.
• Operating and assisting with cardiac output monitoring devices as per standardized protocols; escalating technical faults promptly.
• Collection, labelling, processing, aliquoting, storage and transport of blood samples for biomarker (IL-6, procalcitonin) and routine laboratory analysis, and liaison with the central laboratory.
• Accurate and timely completion of case record forms and data entry into the study database; correction of queries raised during data validation.
• Follow-up of enrolled participants for outcome data up to day 28, including record retrieval and telephonic follow-up where required.
• Maintaining study logs, drug accountability records, sample inventories and consumable stock.
• Reporting any suspected adverse event immediately to the Project Research Scientist-I and the Principal Investigator.
• Assisting in study documentation, filing and audit preparation, and any other technical task assigned by the Principal Investigator in connection with the project.

Eligibility Criteria

Preferred Qualifications

Essential

• Graduate degree in Science / Life Sciences / Nursing (B.Sc. Nursing) / Medical Laboratory Technology / Allied Health Sciences from a recognized university with 3 years of relevant experience; OR
• Post-graduate degree in a relevant subject (Life Sciences, Microbiology, Biochemistry, Biotechnology, Clinical Research, Allied Health Sciences) from a recognized university.

Desirable

• Training or certification in Good Clinical Practice.
• Experience with phlebotomy and sample processing, and familiarity with ICU monitoring equipment.
• Proficiency in computer applications, data entry and electronic data capture systems (MS Excel, REDCap or equivalent).

Age Limit

35 Years

Preferred Language

English

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