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Tuesday, 20 May 2014

Clinical Research Associate ( Executive ) - Vaccines Panacea Biotech - New Delhi, Delhi



Desired Profile 
To 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

Experience
1 - 4 yrs

Age
22-30 yrs

Industry Type
Pharmaceutical

Functional Area
Clinical Research - Vaccines

Education
M.Sc/ M. Pharma

Compensation
At par with the Industry

Department
Clinical Research

Send your application to corporate@panaceabiotec.com.

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