Clinical Research Assoc II jobs in Navi Mumbai at Teva Pharmaceutical Industries Ltd.

Clinical Research Assoc II - 2755

Location: Navi Mumbai, IN, 400706

Job Description :

Ensuring clinical study activities like informed consent process breathe alcohol, Drug of Abuse, check-in, check out, protocol restrictions, standardized meals, follow ups, compilation of documents were performed as per SOP and protocol.
Intimation of Adverse events encountered to Clinical Investigator/ Principle Investigator /Study Physician.
Administration & Supervision of IPs to study subjects.
Reviewing of study related documents and study binders for completeness.
Monitoring of the subjects during clinical confinement.
Ensuring general information to subject for registration, screening and respective study were provided.
Performing & Ensuring plasma separation, storage, segregation & transfer to bioanalytical department is done as per SOP and protocol.
Preparation and checking of labels for vacutainers, plasma separation vials, segregation and medication for pivotal, pilot and blank plasma study.
Preparation and checking of tables (OGD) of pivotal study and assist in pilot study.
Preparation and coordination in pre, during and post study activities.
Implement and ensure all the activities were performed in compliance with SOPs and Protocol.
Ensure that staffs are trained on SOPs, revised SOPs and protocol before performing activities.
Ensure sufficient, qualified, trained and experienced staffs are available to perform the activities.
Ensure all the instruments are calibrated as per the calibration schedule.
Coordinating with Pathology Lab., QA department, statistician, accounts department and other concerned departments for smooth and planned execution of clinical studies or as per need.
Ensure proper handling and maintenance of logbooks.
Any other duty assigned by the Principal Investigator/ Head of department.

Qualifications : 4 years GNM or B Sc Nursing / BscMLT/ PGDMLT

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.