CRA professionals

Syngene

3 - 5 years

2 - 6 Lacs

bengaluru

Posted:18 hours ago| Platform:

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Skills Required

site management clinical operations nutrition gcp site selection pharma stress management clinical research consumer goods recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, Standard Operating Procedures and all the applicable Good Clinical Practice (GCP) Guidelines and Regulations.
Responsible for site management for the assigned protocols, sites and therapeutic areas
Complete appropriate Standard Operating procedure training, therapeutic area training, protocol training and any relevant training required to perform job duties
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectation and activities
Ensure the quality and integrity of study conducted at site level in accordance with protocol and applicable regulations. Investigate and discuss quality issues with Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action
Manage the progress and performance of the assigned study sites by following activities but not limited to: tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentations.
Provide assistance to the Clinical Project Manager with design of study tools, documents and processes.
Timely submission of timesheets for Project specific and other tasks
Supporting the Clinical Project Manager for coordination with-in the project team.
Delegation of project level Clinical Project Manager responsibilities

Educational Qualification: Masters Degree in Life Science / Masters in Pharmacology

Technical/functional Skills: (Maximum 4-6 Points)

Sound knowledge on ICH-GCP and Indian Regulatory guidelines
Well versed with Microsoft Office documents (MS word, Excel, Powerpoint)
Knowledge about developing SOPs
Well versed with facing internal and external audits

Experience:

Mini 3-5 years in core clinical research activities in Clinical Research Activities

Behavioral Skills :

Proficient in English (reading and writing), Stress Management, Empathy, Conflict resolution and Patience

Equal Opportunity Employer:

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