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Jobgether
India
Clinical Research
ICH-GCP
Regulatory Submissions
Regulatory Manager / Senior Regulatory Manager
Precision for Medicine
Regulatory Affairs
Clinical Trials
Drug Development
Senior Clinical Trial Associate
Jobgether
US
Clinical Research
GCP
FDA Regulations
In-House Clinical Research Associate II, Sponsor-Dedicated (Contract)
Premier Research
US
Clinical Trials
Regulatory Compliance
Communication
Clinical Research Associate II / Senior CRA
Ergomed
Clinical Trials
Regulatory Submissions
Communication
Regulatory:
- Prepare and submit Clinical Trial Application Forms and submission dossiers.
- Interact with Competent Authorities and Ethics Committees for approvals.
Site Startup:
- Manage collection of essential documents for site activation.
- Customize Patient Information Sheets and Informed Consent Forms.
Collaboration:
- Partner with CRAs, feasibility, and contracts teams.
- Provide regular updates to project and regulatory leads.
Compliance:
- Maintain knowledge of local clinical trial laws.
- Ensure audit/inspection readiness and TMF filing.
Precision for Medicine
Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.