Job Description
Clinical Research Associate (CRA) With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

TRAVEL REQUIREMENTS:

75%

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participate & provide inputs on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities using various tools.
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact report appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
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• Identify, assess and resolve site performance, quality or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

• Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Support audit/inspection activities as needed.
• Perform co-monitoring where appropriate.