Clinical Enrollment Manager / Patient Navigator

Experienced Senior Clinical Research Associate with a demonstrated history of working in the pharmaceutical industry.

• Skilled in Electronic Data Capture (EDC), SDV, Translation, Oncology, and Feasibility Studies.
• Strong research professional with a postgraduate focused in Medical Law from Criminal Law Cathedral, Jagiellonian University.
• Member of GCP Association.
• Focused on results.
• Engage site staff and investigators in discussion to understand and report challenges in subject enrollment and retention and offer potential solutions.
• Assist in the implementation and oversee the execution of site-based patient recruitment tactics.
• Communicate investigator/study coordinator inquiries requiring follow-up to designated contacts within Geron and/or the Clinical Research team.
• Interpret and report findings with recommendations for action to relevant stakeholders.
• Work toward meeting established program metrics.
• Upon request, educate clinical trial sites and referring physicians about clinical trial protocol, disease state or study design.
• Attend local, regional and national medical conferences to obtain new competitive information, stay informed of clinical trends, and support and maintain relationships with key investigators.
• Complete all administrative responsibilities consistent with SOPs and departmental guidelines including required training, field activity documentation, expense reporting, and other assigned tasks.
• Participate in and successfully complete all internal education/training on SOPs, policies, and relevant products, as well as all compliance training and regulatory education relevant to pharmaceutical industry.
• Interact and build positive relationships with key stakeholders on the Clinical Research team including field monitors, CRAs, CTMs and Geron and CRO staff.
• Coordinate all site facing activities with the appropriate study team members from Geron and CRO.
• Proactively communicate plans, findings and insights to TMAC, CRO and Geron staff.
• Communicate any adverse event information, reports of concern or product complaints in accordance with Geron’s policies.
• Document all interactions and submit executed documents promptly.
• Schedule travel and submit travel expenses within Geron and TMAC travel policies.
• Perform site optimisation services to boost patient recruitment for clients’ clinical trials through community outreach visits.