Central Clinical Research Associate

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 300,000 - 600,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd is seeking a documentation-focused professional to support regulatory submissions and ethics committee processes. You will collect and quality-check site documents for HA/RA submissions and EC/IRB/IRB reviews, prepare EC covers, and manage communications with ECs and sites.

Responsibilities include coordinating insurance certificate applications, assisting with site contracts, customizing informed consent forms to country requirements, and uploading study start-up

Qualifications

• Degree in a Pharma/scientific discipline or related Life science degree.

Responsibilities

• Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
• Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
• Prepare EC cover letter and any additional materials required (if applicable)
• Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
• Prepare the Insurance Certificate application when applicable.
• Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
• Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
• Assist with the upload & file of Study Start-up documentation into the eTMF.
• Ensure that all parties are informed about project Progress, changes, and any issues that arise.

Education

Degree in a Pharma/scientific discipline or a related Life science degree

Job description

Responsibilities

• Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
• Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
• Prepare EC cover letter and any additional materials required (if applicable)
• Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
• Prepare the Insurance Certificate application when applicable.
• Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
• Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
• Assist with the upload & file of Study Start-up documentation into the eTMF.
• Ensure that all parties are informed about project Progress, changes, and any issues that arise.

Qualification

• Degree in a Pharma/scientific discipline or a related Life science degree