Ref #: 29628

Employment type: Permanent - Full-Time

Location: India – Andhra Pradesh/Hyderabad

Posted: 02-Jun-2021


DOCS is currently seeking an experienced Clinical Research Associate for an opportunity based in the (Hyderabad). Below are the insights about the role.

Responsibilities :
The Clinical Research Associate is the person in Trial Coordination and Site Management that serves as 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.

• Required a Bachelor degree with a minimum of 2 years 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.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.