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.
• May serve as the primary contact for clinical trial sites (e.g. site management).
• 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.
• Is responsible for clinical data review to prepare 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 the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
• Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs).
• May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals.
• May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
• Supports project/study budget activities.
• May act as Clinical Safety Coordinator.
• Mentors team members.
• Responsible for communicating business related issues or opportunities to next management level.
• Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
• Develops a strong understanding of the pipeline, product portfolio and business needs.
• Generally manages work with supervision, dependent on project complexity.
• Utilizes independent decision-making for simple to advanced situations but requests guidance for complex situations.
• Responsible for communicating business related issues or opportunities to next management level.

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