Research Analyst

• Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for operating company.
• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
• Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,etc.).
• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
• Manages and oversees ordering, tracking, and accountability of investigational devices and trial materials.
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Interfaces, collaborates, and oversees Clinical Research Associates (CRAs).
• Oversees and supports the development and execution of Investigator agreements and trial payments.
• Prepares data for statistical analyses and publications.
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects.
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
• Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments.

Senior Clinical Research Specialist

Clinical Research Associate – Level II, FSP Oncology

Senior Clinical Research Associate – Oncology

Data Research Specialist

Senior Clinical Research Associate

Principal Operations Research Analyst – SME