Safety Associate (Clinical Trials)

JSS Medical Research; Faridabad District; Hybrid; INR 300,000 - 540,000; Full time

Job summary

JSS Medical Research in India is seeking a Safety Associate to maintain safety files, assist in SAE data handling, and coordinate with sites to collect information within timelines.

The role requires knowledge of safety reporting, PV databases, and Good Clinical Practice guidelines. Proficiency in MS Office and understanding of FDA 21 CFR Part 11 is preferred. 1 year CR experience is beneficial.

Qualifications

• 1 year clinical research experience is preferred.
• Understanding of safety reporting procedures and PV databases.
• Knowledge of GCP and good documentation practices.
• Familiarity with FDA 21 CFR Part 11 regulations for electronic records.

Responsibilities

• Updation and maintenance of all the safety related files of the department.
• Ensure safety related documents are complete and properly filed.
• Assist in follow up of SAE information from sites within timelines.
• Communicate with sites to collect information/queries timely.
• Assist in the preparation of safety narratives.
• Support medical monitors in preparing SMPs and presentations.
• Maintain SAE trackers and software, ensuring timely updates.
• Assist in solving study related queries with latest information via web search.
• Support QA findings and CAPA closure.
• Assist Study Team to ensure protocol compliance with FDA regulations and safety management plan.
• Any other duties as assigned by the supervisor.

Skills

1 Years CR experience

Good Clinical Practices

Good Documentation Practices

FDA 21 CFR Part 11

Education

B.D.S./BHMS/MDS

Tools

MS Office

Job description

Essential Functions:

The following duties represent the principal job duties however they are not all inclusive:

• Updation and maintenance of all the safety related files of the department
• Ensure that appropriate Safety related documents are complete and appropriately filed
• Assist in follow up of all SAE related information/ queries from the respective sites
• Communicate with the sites to collect the information/ queries within the specified timelines
• Assist in the preparation of safety narratives
• Assist the Medical monitors in preparation of safety related documents (SMPs/ Presentations/etc)
• Ensure timely & accurate updates and maintaining SAE related trackers/ software (if any)
• Assist the medical monitors & safety in solving study related queries and providing latest information through web search
• To assist in solving the internal QA findings and CAPA closure
• Assist the Study Team to assure compliance with protocol requirements, FDA regulations, Good Clinical Practice and Safety Management Plan
• Any other duties as assigned by the supervisor in the department.

Skills and Qualifications:

Knowledge of:

• 1 Years CR experience
• B.D.S./BHMS/MDS
• Understanding of safety reporting / PV database etc.
• MS Office
• Requirements of Good Clinical Practices
• Requirements of Good Documentation Practices
• Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records