Clinical Research Associate

2 weeks ago

Bengaluru, India Bioagile Therapeutics Pvt. Ltd Full time

**Job responsibilities for a Clinical Research Associate**
- Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Clinical Practices (GCP), and protocol compliance.
- Uses judgment and experience to evaluate the overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Assist in drafting and/or review of various SOPs and project-specific plans of the company. Identify central lab, language translations, logistics vendors and assist in their qualification procedures and further communications.

** For the Clinical Monitoring/Site Management Plan (CMP/SMP)**:

- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- Applies query resolution techniques remotely and on-site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
- Verifies site compliance with electronic data capture requirements

organizational procedures to ensure IP is appropriately (re)labeled, imported, and released/returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables, and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals/targets.
- May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project-specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Work Remotely
- No

**Salary**: ₹12,879.26 - ₹30,448.70 per month

**Benefits**:

- Health insurance

Schedule:

- Day shift
- Weekend availability

**Experience**:

- Clinical research Associate: 3 years (preferred)

**Speak with the employer**

+91-XXXXXXXXXX

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