Teva Pharmaceuticals is a global leader in the development and manufacturing of generic medicines. With a mission to make good health more affordable and accessible, Teva serves millions of patients across nearly 60 countries. As one of the world’s largest producers of generic drugs, Teva is committed to improving health outcomes through its extensive portfolio of medications, including those listed on the World Health Organization’s Essential Medicines List. Join Teva Pharmaceuticals and be part of a company that strives to improve the lives of over 200 million people worldwide every day.
Responsibilities in the Job: As a Clinical Research Associate I at Teva Pharmaceuticals, your role will involve a range of responsibilities aimed at ensuring the smooth operation and successful completion of bioavailability (BA) and bioequivalence (BE) studies. Your key duties will include:
- Overseeing the smooth running of BA/BE studies, ensuring regulatory compliance and adherence to ethical standards.
- Collecting, compiling, and reviewing data obtained from research, ensuring it meets the required quality standards.
- Informing participants about the study during the Informed Consent Form (ICF) process and engaging with them throughout the study.
- Involvement in the Investigational Product (IP) administration process.
- Acting as a custodian and monitoring research participants to ensure adherence to study rules and ethical guidelines.
- Ensuring compliance with research regulatory standards, ICH-GCP, and Good Laboratory Practices (GLP).
- Maintaining detailed records of studies, including drug administration, subject-specific case report forms, and other critical documentation.
- Coordinating with pathology laboratories for screening, post-study, and follow-up sample analysis.
- Participating in the subject enrollment efforts for new BA/BE studies.
- Ensuring necessary supplies and equipment for the study are available before initiation.
- Engaging with study staff to ensure timely completion of documentation and project timelines.
- Collecting data as per the protocol and ensuring the timely completion of Case Report Forms (CRFs).
- Maintaining study documentation and ensuring files are updated in accordance with in-house SOPs, including consent forms, source documentation, and investigational material accountability forms.
Qualifications: To be considered for the Clinical Research Associate I position, candidates should meet the following qualifications:
- B. Pharm, M. Pharm, or M.Sc. (Clinical Research) degree.
- A minimum of 2-8 years of experience as a Clinical Research Coordinator, preferably in a reputed BA/BE center.
Skills:
- Strong knowledge of ICH-GCP guidelines and regulatory requirements in clinical research.
- Experience in managing and overseeing BA/BE studies.
- Excellent data management and documentation skills.
- Strong communication and interpersonal skills, with the ability to engage with subjects and study staff effectively.
- Ability to work in a fast-paced environment and maintain study timelines.
- Attention to detail in maintaining accurate and complete study documentation.
- Ability to work independently and as part of a team.
