Support the implementation of clinical research projects, monitor studies, ensure audit readiness, and provide training on regulatory compliance and documentation.
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
How will you make an impact:
- Support implementation of assigned clinical research projects related to specific products/topics according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. Maintain close contact with clinical study site coordinators and physicians who are clinical investigators.
- Monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts and exam results for consistency with the case report form, review compliance with the clinical investigation plan, as well as to monitor clinical trial/study safety, in keeping with protocols, good clinical practices and regulatory requirements. Document all findings in the monitoring visit reports and escalate to study management as appropriate. Support assigned clinical sites throughout the study process to ensure compliance and study deliverables are met.
- Ensure Audit readiness for internal, external and site Audits by conducting reviews, and collecting and maintaining essential documentation (including ethics and governance documentation). Participates in internal and competent authority (e.g., FDA, TGA, Medsafe) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices and align with global study teams, Edwards internal SOPs, and local regulations.
- Partner with cross-functional teams in the US to keep global alignment (e.g., clinical data management, field monitoring, site management operations, safety, data management) to assist with query management, data reviews and resolution. Escalate issues to the relevant functional team and participate actively in project team meetings with accountability for achieving and reporting on agreed clinical milestones and closely collaborate with internal stakeholders to ensure proper project conduct.
- Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas.
- Ensure adverse events and device-related deficiencies are reported to the Sponsor within the required timeframe. Identify product complaints and report in accordance with regulatory and internal requirements.
- Deliver technical training to internal and external stakeholders on GCPs, protocols, database, compliance, device accountability, adverse event reporting, complaint handling, study investigation protocols, amendments and regulatory documentation requirements. Identify and deliver additional training or coaching for allocated investigative sites where non-compliance is identified.
- Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. Liaise with Compliance and Legal Counsel to create and amend clinical trial agreements.
- Other incidental duties
What you'll need (Required):
- Bachelor's Degree in related field, 3 years experience previous related medical device and /or clinical Required
What else we look for (Preferred):
- Excellent communication and organizational skills
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
- Good problem-solving and critical thinking skills
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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