Job Description
Responsibilities include, but are not limited to:- Performs clinical study sitemanagement/monitoringactivities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works 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.
- Supports and/or leads audit/inspection activities as needed.
CORE Competency Expectations:- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective
• Effectivetime management, organizational and interpersonal skills, conflict management, problem solving skills.• Ableto work highly independently across multiple protocols, sites and therapy areas.• Highsense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.• Demonstratescommitment to Customer focus.Current Contingent Workers apply
Not Indicated
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