Clinical Trial Assistant

Life Force; Mumbai; On-site; INR 400,000 - 600,000; Full time

Job summary

A healthcare research organization in Mumbai is seeking a Clinical Research Associate. The role involves managing protocols, patient recruitment, and adherence to regulations in drug trials. Applicants should have a BHMS or related degree with a clinical research course. Responsibilities include developing trial documents, ensuring drug accountability, and SOP implementation. Proficiency in scientific writing and ICH-GCP knowledge is essential in a dynamic research environment.

Qualifications

• Responsible for writing and managing protocols, recruitment, and patient screening.
• Maintain source documentation and drug accountability.
• Development of study documents for Homeopathic pathogenetic trial.

Responsibilities

• Involvement in new drug development process.
• SOP development and implementation.
• Drug trial supply management.

Skills

Drug proving (for BHMS only)

Scientific writing

Knowledge of ICH-GCP

Protocol reading

Clinical trials – preclinical studies, phases 1-4, SOPs

Source documentation

MS WORD

EXCEL

POWER POINT

Education

BHMS (preferred) / BAMS / MSc in clinical research / B Pharm with clinical research course

Job description

• Responsible for writing and managing protocols, recruitment, patient screening, patient consent forms and follow up management with Investigator.
• Maintain source documentation and drug accountability, AE/SAEs reporting, maintaining site master file.
• Development of study documents for and Management of Homeopathic pathogenetic trial (applies to BHMS doctor)
• Involvement in new drug development process, management of drug manufacturing record
• SOP development and implementation
• Drug trial supply management

SKILLS

• Drug proving (for BHMS only)
• Scientific writing
• Knowledge of ICH-GCP,
• Protocol reading,
• CLINICAL TRIALS –preclinical studies, phases 1-4, SOPs,
• Source documentation, Responsibilities of sponsor, investigator, ethics committee & staff, Site initiation, ICF, Screening, recruitment s, process, Paper CRF completion and Brief knowledge of Data entry and manuscript writing
• MS WORD, EXCEL, POWER POINT

Qualification

BHMS (preferred) /BAMS/ with clinical research course Or MSc in clinical research B Pharm with clinical research course