HomeClinical TrialsClinical Research Associate | Alkem Laboratories | Mumbai

Clinical Research Associate | Alkem Laboratories | Mumbai

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Founded 4 Decades ago Alkem Laboratories is now amongst India’s largest Generic and Specialty Manufacturing Company

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Alkem has registered Many Brands amongst the Top 50 Brands in India Like, Clavam, Taxim, Pan, Pan D. The dominance of Alkem in the Anti Infective segment remains unchallenged.

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

Job Description:

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

Salary: Negotiable

Contact Details:

hrd@alkem.com, swati.upadhyay@alkem.com

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