Ref #: 31785
Employment type: Permanent – Full-Time
Location: Hyderabad, Kerala
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical industry, then here is your chance. We are hiring a Clinical Research Associate II to work closely with our client, a leading pharmaceutical company.
As a CRA II, you will work on clinical trial monitoring based on your experience.
Required experience and qualifications:
• Required a Bachelor’s degree with a minimum of 2 years of clinical trial monitoring experience.
• Previous monitoring experience in Global trials preferred.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and
associated protocol-specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel.
• Good written and oral communication skills.
Key responsibilities :
The Clinical Research Associate is the person in Trial Coordination and Site Management that serves as a primary contact point between the sponsor and the investigational site.
This position is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company’s Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through database lock.
Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols.