Site Support Specialist (Remote)

Fresenius - Waltham, MA

Full-time - Entry Level

Remote - Waltham, MA

Ambulatory Health Care Services

About the position

The Site Support Specialist is responsible for providing operational and administrative support to the research site network, ensuring the smooth functioning of research activities within the FKC clinics. This role requires excellent organizational skills, attention to detail, and the ability to work effectively in a fast-paced environment, both independently and as part of a team.

Responsibilities

• Create and collect feasibility documents from investigative sites; review and prepare feasibility documents for sponsor site selection process.
• Coordinate with research site staff to ensure all necessary equipment, materials, and resources are available for research activities.
• Initiate and track the FKC Governing Body review and approval for study conduct at Fresenius facilities.
• Collect enrollment status of research patients to assure each subject is flagged appropriately in the Fresenius systems.
• Utilize databases and programs as necessary.
• Liaise with appropriate technical support for issue resolution.
• Provide basic technical training on system processes to research site staff as necessary.
• Collect and prepare information for use in discussions/meetings.
• Assist in drafting and formatting reports, presentations, and other documents.
• Provide administrative support, including scheduling and meeting coordination.
• Effectively communicate with internal and external personnel, clients, and vendors.
• Serve as a liaison between research site staff, principal investigators, and other stakeholders.
• Maintain up-to-date knowledge of regulatory requirements and safety protocols to meet FDA/ICH/GCP guidelines.
• Help clinical research and facility staff adhere to company-wide policies and procedures.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

Requirements

• Associate's and/or bachelor's degree in a relevant subject matter or 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.
• 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.

Nice-to-haves

• Experience with an electronic Clinical Trial Management System preferred.