Clinical Trial Assistant
2 months ago
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
- **Drug proving (for BHMS only)**:
- **Scientific writing**:
- **COMPUTER SKILLS**:MS WORD, EXCEL, POWER POINT
**SKILLS**
- 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
**Qualification**
BHMS (preferred) /BAMS/ with clinical research course
Or MSc in clinical research
B Pharm with clinical research course
**PPA Lience**
**Job Types**: Full-time, Regular / Permanent
**Salary**: ₹15,000.00 - ₹22,667.58 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
- Fixed shift
- Morning shift
- Weekend only
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Bachelor's (required)
**Experience**:
- total work: 2 years (required)
**Language**:
- English (required)
**Speak with the employer**
+91 9136150888
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