Responsibilities:
- 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.
- Site monitoring, Inspection, Audit etc.
- 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,
- Drug development,
- 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