Site Support Specialist (Remote)

PURPOSE AND SCOPE : The Site Support Specialist will play a crucial role in providing operational and administrative support to the research site network.

Primary responsibilities will include ensuring smooth functioning of research activities within the FKC clinics by offering logistical, technical, and administrative assistance.

This role demands meticulous attention to detail, excellent organizational skills, and the ability to work effectively in a fast-paced research environment, both individually and with a team.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

• Creates and collects feasibility documents from investigative sites; reviews and prepares 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.
• Initiates and tracks the FKC Governing Body review and approval for study conduct at Fresenius facilities.
• Collects enrollment status of research patients to assure each subject is flagged appropriately in the Fresenius systems.
• Effectively utilizes databases and programs as deemed necessary.
• Liaise with appropriate technical support for issue resolution.
• Provide basic technical training on system processes to research site staff as necessary.
• Collects and prepares information for use in discussions / meetings.
• Assist in drafting and formatting reports, presentations, and other documents.
• Provides administrative support, including scheduling and meeting coordination.
• Effectively communicates with internal and external personnel, as well as clients and vendors.
• Serve as a liaison between research site staff, principal investigators, and other stakeholders.
• Serves as a resource for clinical research staff by maintaining up-to-date knowledge of regulatory requirements, and safety protocols to meet FDA / ICH / GCP guidelines.
• Helps clinical research and facility staff adhere to the broad activities of the business unit(s) through the interpretation, application and implementation of 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.
• Must maintain confidentiality and a high degree of sensitivity inside and outside of the company.
• Other duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS :
• This position may require occasional travel to research sites or conferences.
• Flexible working hours may be necessary to accommodate research activities. Note : The responsibilities and qualifications outlined above are intended to provide a general overview of the role of Network Research Site Support.

Specific duties and requirements may vary depending on the nature of the research projects and the organization's needs.

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Travel 10% or less.
• Availability outside of office hours required as needed (through e-mail, phone, etc.) SUPERVISION : None EDUCATION AND REQUIRED CREDENTIALS :
• Required : 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. EXPERIENCE AND SKILLS :
• 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. ACKNOWLEDGEMENT : I acknowledge that I have read and accepted this job description.

I understand what is expected of me in this position, and I am able to perform the essential functions as outlined with or without reasonable accommodation.

Furthermore, I understand that the duties and responsibilities listed in this job description are intended only as illustrations of the various types of work that may be performed.

The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

If I have any questions about duties and responsibilities not specified in this job description that I am asked to perform, I should discuss them with my immediate supervisor or my Human Resources representative.

Employee Name (Please Print) Employee Signature Date EO / AA Employer : Minorities / Females / Veterans / Disability / Sexual Orientation / Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EO / AA Employer : Minorities / Females / Veterans / Disability / Sexual Orientation / Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.