Alkem Laboratories – Urgently Opening for Clinical Research
Company: Alkem Laboratories
Location: Taloja, New Mumbai
Department: Clinical Research
Qualification: M.Pharm, B.Pharm, BAMS
Experience: 01-03 years
•Conduct site feasibility (Identification & selection)
•Perform EC submission.
•Prepare/Review of SIV package (including SMF).
•Coordination with various stake holders eg. IP depo, IVRS, central laboratory, logistics vendors etc for site related activities.
•Ensure that the sites have the required clinical supplies for proper conduct of the study.
•Perform site visits i.e. site selection, initiation, monitoring & close out, prepare and submit follow up letter, visit reports as per SOP & monitoring plan Perform SDV & CRF review as per the monitoring plan.
•Review key study quality metrics (e.g, eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team. Follow up with sites for issue resolution and implementing САРА.
•Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines. Follow up with data management team for timely resolution of data queries.
•Coordinate with sites in case of SAEs and ensuring timely reporting to all stakeholders.
•Initiate & track investigator, site and vendor payments. Review & timely update Trial Master File & study folder as
per SOP/study requirements.
•Maintain and update study trackers (eg. Annexure I) & Systems (e.g. CTMS) for the assigned projects.
•Regularly obtain updated trackers/logs from sites applicable.
•Follow up with the sites/vendors for all the pending documents.
•Keep the study project manager and other team members informed of updates from sites.
•Coordinate study document archival at sites. Author or review SOPs as and when designated.
•Complete assigned trainings & maintain updated personal training file for records.