Clinical Research Associate I
4 days ago
About the Role
We are seeking a skilled Clinical Research Associate I to join our team at Teva Pharmaceuticals. In this role, you will be responsible for overseeing the smooth running of BA/BE studies, collecting and compiling data, and ensuring adherence to research regulatory standards and in-house SOPs.
Key Responsibilities
- Oversee the smooth running of BA/BE studies, ensuring timely completion of documentation and meetings with study staff.
- Collect, compile, complete, and review data obtained from research, maintaining detailed records as per FDA and other required guidelines.
- Inform participants about the study during the informed consent process, ensuring they understand their roles and responsibilities.
- Get involved in the Investigational Product administration process, coordinating with pathology laboratories for screening, post-study, and follow-up sample analysis.
- Act as a custodian and monitor research participants to ensure adherence to study rules, regulations, and SOPs.
- Adhere to research regulatory standards, including ICH-GCP and GLP, and in-house SOPs, ensuring compliance with all applicable laws and regulations.
- Maintain detailed records of studies, including drug administration and subject-specific case report forms, ensuring accuracy and completeness.
- Coordinate with pathology laboratories regarding screening, post-study, and follow-up sample analysis, ensuring timely completion of studies.
- Participate in subject enrollment efforts for new BA/BE studies, ensuring the necessary supplies and equipment are available before initiation.
- Engage with study staff to ensure timely completion of study documentation, meeting stringent timelines for project submission.
- Collects data as required by the protocol, assures timely completion of Case Report Forms, and maintains study timelines.
- Completes study documentation and maintains study files in accordance with requirements, including consent forms, source documentation, case report forms, and investigational material accountability forms (if required).
- Engage with subjects and understand their concerns, ensuring their needs are met and their participation is valued.
About You
We are looking for a highly motivated and organized individual with a B. Pharm, M. Pharm, or M.Sc. (Clinical Research) degree and at least 2-8 years of experience as a Clinical Research Coordinator in a reputable BA/BE center. You should have excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
About Teva
Teva Pharmaceuticals is committed to equal opportunity in employment and is an equal opportunity employer. We celebrate diversity and are proud to be an inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process.
Why Join Us
As a Clinical Research Associate I at Teva Pharmaceuticals, you will have the opportunity to work on exciting projects, develop your skills, and contribute to the development of new medicines. You will be part of a dynamic team that is passionate about making a difference in the lives of patients worldwide. Join us and be part of a company that is committed to innovation, quality, and excellence.
Equal Employment Opportunity
Teva Pharmaceuticals is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment where everyone feels valued, respected, and supported. If you require any accommodations during the recruitment process, please let us know and we will do our best to support you.
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