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Zuventus Healthcare
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Clinical Research Associate

Clinical Research Associate

Zuventus Healthcare

0 - 3 years

|

5 - 6 Lacs

Posted:2 hours ago| Platform:

Apply

Skills Required

training cro publishing clinical trials clinical research associate archiving protocol designing operations monitoring auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Ficial:

Negotiating clinical trial budget with the CROs/Investigators.

Operational:

Preparation and amendment of SOPs for clinical trial activities.
Clinical trial sites qualification and selection.
Tracking payments made to the CRO/Investigators/Ethics Committees
Protocol Designing
Case Report Form (CRF) Designing
Preparation of dossier/documents for Regulatory submission
Addressing DCG(I) queries
Co-ordination with the CRO for timely completion of the clinical trial activities
Protocol training of the study staff
Monitoring and auditing clinical trial sites
Coordinate with investigators for conduction of clinical trials
Archiving study documentation and correspondence
Source Data Verification: Verifying that data entered in the CRFs is consistent with source data
Analyzing the clinical study data
Preparing DCG(I) presentations
Preparing Clinical study reports
Preparing PSURs
Preparing manuscripts for publication
Reviewing the BA/BE protocols as per the regulatory requirements.

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Zuventus Healthcare

Pharmaceuticals

Pune

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