Site Support Specialist

2 days ago

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Fresenius Medical Care

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dialysis • hemodialysis • home dialysis • kidney disease • renal care

10,000+

Description

• Play a crucial role in providing operational and administrative support to the research site network. • Ensure smooth functioning of research activities within the FKC clinics by offering logistical, technical, and administrative assistance. • Create and collect feasibility documents from investigative sites and prepare for sponsor site selection process. • Coordinate with research site staff to ensure all necessary equipment, materials, and resources are available for research activities. • Provide basic technical training on system processes to research site staff as necessary. • Assist in drafting and formatting reports, presentations, and other documents. • Effectively communicate with internal and external personnel, clients and vendors.

Requirements

• Associate’s and/or bachelor’s degree in subject matter relevant to the position (if no Bachelors, then 5 years of direct relevant experience in a similar role in the Pharmaceutical/Biotech or Device industry). • Participation in and documentation of training on GCP/ICH Guidelines and FDA regulations for clinical trials in the drug, biotech or device industry. • 2 years of related experience in the Pharmaceutical/Biotech or Device industry. • Familiarity with study compliance (FDA, ICH GCP) and local regulations. • Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance required. • Advanced computer proficiency, especially MS Office. • Ability to multi-task, work independently, take initiative, and complete tasks to deadline. • Excellent oral and communication skills. • Superior customer service skills. • Excellent time management and organizational skills. • Experience with an electronic Clinical Trial Management System preferred.