Lambda Therapeutic Research
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.
Job Title: Protocol Writer
No. of Posts: 3
Experience : 2 – 7 Years
Location : Ahmedabad(Gota)
Job Description:
Feasibility
- To conduct the feasibility for the late phase Clinical trials as per the requirements of the sponsor.
Medical Writing
- Prepare and review study related documents like Protocol Synopsis, Study Protocols, Investigators Brochure,
- Informed consent forms, Clinical study reports, Patient diaries, Case Record Form etc.
- Liaises with the study team, Sponsor and the key opinion leaders in therapeutic areas to finalise the study related documents.
Training
- Train the study team members of the study protocols and other study related documents.
- Train the members of the department on the various therapeutic / technical areas
Pharmacovigilance
- To ensure that safety information received from the site/sponsor is processed consistently, accurately, in a timely manner and in compliance with GCP/protocol/agreed SOPs /Schedule Y and reported to DCGI and appropriate personnel.
- To Liaise with the study team and the site personnel to get additional information and documents.
General Duties
- Keep abreast with the development in the field of clinical research in India and overseas.
- Comply with quality initiatives designed by the department.
Qualifications:
Education:
- UG -B.Pharma – Pharmacy, MBBS – Medicine
- PG – M.Pharma – Pharmacy, Medical-MS/MD – Any Specialization, PG Diploma – Any Specialization
