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Clinical Research Monitor / CRA / Project Manager

Clinical Research Monitor / CRA / Project Manager

Apothecaries

3 - 8 years

6 - 10 Lacs

Gurugram

Posted:1 week ago| Platform:

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Skills Required

Monitoring CRA Quality Assurance Clinical Trials

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Work from Office

Job Type

Full Time

Job Description

The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training and close-out. Responsibilities will include: 1. Managing execution of clinical trial projects from initiation to closeout - across multiple projects, sites and teams. 2. Managing site relationships for ensuring and securing compliance with regulations, budgets and timelines. 3. Providing operational insights for compliance with Protocol, SOPs, policies and practices. 4. Collaborating with project teams and sponsors. 5. Site qualification, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out. 6. Training and oversight of site staff. 7. Periodic reviews of site-level KRIs. 8. Early identification of site-level risk/issue(s) occurring during study conduct; Escalating issues to project teams. 9. Maintaining Trial Master File (TMF). 10. Coordinating study supplies, biospecimen management, and coordination with various stakeholders. 11. Data query resolutions. 12. Supporting audit readiness and preparations. 13. Preparing study progress and performance metrics. 14. Travel to investigative sites (up to 25%). Preferred candidate profile 1. Rich experience in clinical research operations and project management, preferably in global clinical trials. 2. A degree in medicine, pharmacy or life sciences. 3. In-depth understanding of clinical research regulations, industry standards and GCP. 4. Excellent verbal and written communication skills. 5. Proficiency in using MS Word & MS Excel.

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Clinical Research Monitor / CRA / Project Manager

Gurugram

3.0 - 8.0 yrs

INR 6 - 10 Lacs

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Apothecaries

www.apothecaries.com

Pharmaceuticals & Health

Nature Town

50 Employees

1 Jobs

Key People

John Smith

CEO
Jane Doe

Chief Pharmacist
Emily Johnson

Marketing Director

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Clinical Research Monitor / CRA / Project Manager

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Clinical Research Monitor / CRA / Project Manager

Experience & Salary

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