Teva Pharmaceuticals is currently seeking a Clinical Research Associate I in Navi Mumbai, India. This role involves monitoring clinical trials to ensure compliance with protocols, regulatory requirements, and company standards. Candidates should possess a bachelor’s degree in life sciences or a related field, along with relevant clinical research experience required.
Clinical Research Associate I
Date: Nov 11, 2024
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 58562
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day
- Overseeing the smooth running of BA/BE studies.
- Collecting, compiling, completing and reviewing data obtained from research.
- Informing participants about study during ICF process.
- Get involved in the Investigational product administration process.
- To act as a custodian and monitoring of research participants to ensure adherence to study rules.
- Adhering to research regulatory standards and in-house SOPs.
- Adhering to ethical standards like ICH-GCP and GLP.
- Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.
- Co-ordination with pathology laboratory regarding screening, post study and follow up sample analysis.
- Participating in subject enrollment efforts for new BA/BE studies.
- Ensuring that the necessary supplies and equipment for a study are available before initiation of study.
- Engaging with study staff for timely completion of study documentation to meet stringent timelines of project submission.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Completes study documentation and maintains study files in accordance with requirements as per in house SOPs and procedures including, but not limited to, consent forms, source documentation, case report forms and investigational material accountability forms (if required).
- Engaging with subjects and understanding their concerns.
Your experience and qualifications
- B. Pharm, M. Pharm or M.Sc. (Clinical Research).
- At least 2-8 years of experience as a Clinical Research Coordinator in reputed BA/BE center.