Role: Clinical Research Associate / CRA
Education: Graduation in Any discipline
Salary: As per industry norms
Location: Delhi
Job Responsibilities:
Desired ProfileTo develop Clinical Trial for Vaccines/BA - BE related documents
To assist project manager in site selection and training site personnel
To assist in required regulatory submissions & approvals for the conduct of the study
To conduct site initiation visits as needed for training site personnel about the protocol and study procedures
Provide feedback to assigned sites and information regarding detected deficiencies and corrective action needed.
Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
Conduct site close out visits to ensure accuracy and completeness of trial related documents and closing of the trial at the site. To keep a close association with site personnel for: patient Recruitment and patient follow-up
Preparation and Maintenance of Clinical Trial Master File
Resolving all trial related queries, raised from Clinical data management
Assisting project manager/managers/ sr. manager to respond to all QA/ Audit findings and coordinating with study sites and vendors for corrective action plans
Provide overall management of clinical trials or clinical programs
Ensure the project is completed within budget, schedule and according to contract specifications
Assisting Managers to arrange literatures and references for articles/publications/presentations
To ensure that data is provided to data management for preparation of validation guidelines for a clinical study, data entry and queries resolution
To prepare Standard Operating Procedures
To assist project manager in site selection and training site personnel
To assist in required regulatory submissions & approvals for the conduct of the study
To conduct site initiation visits as needed for training site personnel about the protocol and study procedures
Provide feedback to assigned sites and information regarding detected deficiencies and corrective action needed.
Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
Conduct site close out visits to ensure accuracy and completeness of trial related documents and closing of the trial at the site. To keep a close association with site personnel for: patient Recruitment and patient follow-up
Preparation and Maintenance of Clinical Trial Master File
Resolving all trial related queries, raised from Clinical data management
Assisting project manager/managers/ sr. manager to respond to all QA/ Audit findings and coordinating with study sites and vendors for corrective action plans
Provide overall management of clinical trials or clinical programs
Ensure the project is completed within budget, schedule and according to contract specifications
Assisting Managers to arrange literatures and references for articles/publications/presentations
To ensure that data is provided to data management for preparation of validation guidelines for a clinical study, data entry and queries resolution
To prepare Standard Operating Procedures
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