Clinic Study Administrator

1 month ago

Navi Mumbai, India Teva Pharmaceuticals Full time

The opportunity

The Clinic Study Administrator is a specialized research professional working with and under the direction of the Team lead, manager clinical operations and clinical Principal Investigator (PI).Clinic Study Administrator supports, facilitates and coordinates the daily BA/BE study activities and plays a critical role in the conduct of the study. Clinic Study Administrator need to engage with research subjects, explain ICFs to them and understand their concerns, requiring excellent interpersonal and communicative skills, Enrollment procedure.

How you’ll spend your day

Participating in subject enrollment efforts for new BA/BE studies. To co-ordinate the screening activities for timely start of studies including counselling Volunteers prior to enrollment into the study. To ensure that the screening activities are carried out in accordance with the principles of GCP and in compliance with the EC approved general screening protocol/procedure and approved study protocol (when applicable). Communicate with volunteers regarding clinical trials and obtaining general consent from them. Ensure that study specific tests if any are performed only after obtaining the additional consent. Ensure that copy of consent obtained at the time of performing X-Ray is maintained for each study where the X-rays are used. To ensure that all the staff in the screening department is adequately trained and to arrange for training if required. To ensure that the Subject database is well maintained including updating of AE's, UDS, ABA after the study completion. Co-ordination with pathology laboratory regarding screening, post study and follow up sample analysis. To ensure consistency in the screening activities and to prepare study information. To assist in check-in process. To check the X-ray accountability before archival. To participate in Informed consent process whenever applicable. To ensure that the screening area is maintained clean and free from clutter. Co-ordinate with Head-Clinical operations in all study related activities. Engaging with subjects and understanding their concerns. To carry out other responsibilities as and when assigned by the management.

Your experience and qualifications

Education: Any Graduate and DMLT, BSc. Nursing. Experience: More than 2 years of experience as a Volunteer Recruitment and Phlebotomist/Nurse in reputed BA/BE center.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and 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. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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