Research Associate - Protocol Writing

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

Department: Clinical Pharmacology and Medical Affairs

Designation: Research Associate - Medical Writer

Education: M. Pharm/B. Pharm

Experience: 1-2 yrs.

Location: Ahmedabad (Gujarat)

CTC Range: 4 LPA to 5 LPA

Job Description:

• Preparation and quality check (QC) review of clinical study documents like, clinical trial protocols, Informed Consent Form, subject diaries etc., ensuring that the documents are written appropriately in compliance with in-house SOPs and regulatory requirements.
• Communication with sponsors, IEC/IRB and coordination with Principal Investigator, and other departments for protocol related inputs during review and finalization.
• Preparation and comparison of project related Informed Consent Form (ICF) and other supportive documents in vernacular language.

COMPETENCIES