Teva Pharmaceuticals is on a mission to make healthcare more affordable and accessible worldwide. As the leading global manufacturer of generic medicines, Teva is committed to improving the lives of millions of people every day. With a presence in nearly 60 countries, Teva produces numerous products featured on the World Health Organization’s Essential Medicines List. The company’s dedication to its mission and the diversity of its workforce help Teva drive innovation and positive change in the pharmaceutical industry.
How You’ll Spend Your Day
As a Clinical Research Associate I at Teva Pharmaceuticals, you will play a critical role in overseeing the smooth running of Bioavailability/Bioequivalence (BA/BE) studies. Your responsibilities will include:
- Study Oversight: Ensuring the efficient operation of BA/BE studies, including overseeing study timelines and ensuring adherence to study rules and ethical standards such as ICH-GCP and GLP.
- Data Management: Collecting, compiling, and reviewing data obtained from research, including completing Case Report Forms (CRFs) and maintaining study documentation in accordance with FDA and other guidelines.
- Participant Engagement: Informing research participants during the informed consent process, monitoring adherence to study protocols, and addressing participant concerns.
- Study Coordination: Working with the pathology laboratory for sample analysis, assisting with subject enrollment, ensuring that study supplies and equipment are available, and engaging with study staff to meet submission deadlines.
- Regulatory Compliance: Adhering to research regulatory standards and internal Standard Operating Procedures (SOPs), and ensuring the timely completion of all study documentation.
Your Experience and Qualifications
To be successful in this role, you should have:
- A B. Pharm, M. Pharm, or M.Sc. (Clinical Research) degree.
- A minimum of 2-8 years of experience as a Clinical Research Coordinator in a reputed BA/BE center.
- Familiarity with study protocols, regulatory standards, and ICH-GCP/GLP guidelines.
- Strong organizational skills to ensure timely completion of study timelines and documentation.
- Ability to engage with study participants and address their concerns effectively.
