Teva Pharmaceuticals, a leading global manufacturer of generic medicines, is seeking a Clinic Study Administrator in Navi Mumbai, India. With a mission to make healthcare more affordable and accessible, Teva produces essential medicines for millions worldwide and operates in nearly 60 countries. This role is integral to ensuring the smooth conduct of Bioavailability/Bioequivalence (BA/BE) studies.
Key Responsibilities
As a Clinic Study Administrator, your day-to-day tasks will include:
- Subject Enrollment: Participate in enrolling subjects for BA/BE studies, including explaining informed consent forms (ICFs) and addressing any concerns from research subjects.
- Screening and Counseling: Coordinate screening activities and ensure they adhere to Good Clinical Practice (GCP) guidelines. Counsel volunteers before enrollment and ensure study protocols are followed.
- Consent Management: Communicate with volunteers about the trials, obtain general and additional consents for study-specific tests, such as X-rays, and maintain consent records for each study.
- Staff Training: Ensure that screening staff are adequately trained and arrange for additional training as needed.
- Database Management: Maintain a well-organized subject database, including updates related to adverse events (AEs), urine drug screening (UDS), and after-study reports.
- Coordination with Labs: Coordinate with pathology laboratories regarding sample analysis for screening, post-study, and follow-up purposes.
- Study Preparation and Co-ordination: Collaborate with the Head of Clinical Operations to prepare study materials and manage study-related activities.
- Maintain Screening Area: Ensure the screening area is clean and free of clutter.
- Informed Consent Process: Participate in the informed consent process and assist with the check-in process.
- General Support: Perform other responsibilities as assigned by management.
Required Experience and Qualifications
- Education: Any graduate, along with DMLT (Diploma in Medical Laboratory Technology) or a B.Sc. in Nursing.
- Experience: Over 2 years of experience as a Volunteer Recruiter or Phlebotomist/Nurse in a reputed BA/BE center.
