Founded 4 Decades ago Alkem Laboratories is now amongst India’s largest Generic and Specialty Manufacturing Company
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Alkem has 21 Manufacturing Units in India and Across The world, and are Inspected by Worlds main Regulatory Bodies and Approved like USFDA/MHRA/TGA, etc
Position: Clinical Research Associate
Location: Mumbai, Maharashtra, India
Roles and Responsibilities:
- Conduct site feasibility (Identification & selection)
- Perform EC submission
- Prepare/Review of SIV package (including SMF).
- Coordination with various stakeholders eg. IP depo, IVRS, central laboratory, logistics vendors, etc for site-related activities
- Ensure that the sites have the required clinical supplies for the proper conduct of the study.
- Perform site visits i.e. site selection, initiation, monitoring & closeout, 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 the appropriate action in conjunction with the study team.
- Follow up with sites for issue resolution and implementing CAPA.
- Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
- Follow up with the data management team for timely resolution of data queries.
- Co-ordinate 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, as 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.
- Co-ordinate study document archival at sites.
- Author or review SOPs as and when designated.
- Complete assigned training & maintain updated personal training file for records.
Desired Candidate Profile :
- Experience: At least 1-2 years of monitoring, experience in Handling Phase 2 & 3 studies,
- Submission: US-FDA/ EMEA/ DCGI
- Trained on ICH-GCP, Sch-Y, and Indian GCP
- Preferably experienced in Oncology, Ophthalmology & cardiology studies.
Qualification: B.Pharm/ M.Pharm/ BHMS/ BAMS/ BDS/PhD
Experience: 2-7 Years
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