Siro Clin Pharm looking for experienced CRAs/ Clinical Research Associate/ in Mumbai

Roes & Responsibilties:

To ensure all relevant studies follow SIRO/applicable SOPs, GCP and local regulations.

To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.

In coordination with the project manager, perform study site selection and qualification visits. Also to participate in/conduct investigators meeting and site initiation visits.

To identify, define, coordinate and conduct site study training.

In coordination with the project manager, provide oversight of all study-related activities.

To perform regular monitoring visits to site

To prepare monitoring reports.

To maintain audit readiness at the site level.

To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.

To ensure site level metrics (i.e. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate

Issue Resolution

Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level.

Ensure proper escalation of site/project related issues

. Intervention and Coaching

. Teamwork

Liaison with Other Departments

Role:

Clinical Research Associate/ Scientist

Required Experience:

2-7 Years

Location:

Thane

To visit Siro directly