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Form of workThis position supports the Frenova Renal Research division of Fresenius Medical Care.
PURPOSE AND SCOPE: Primary responsibilities are collection, accuracy, and validity of all clinical research regulatory documents at all sites contracting with Frenova Renal Research (Frenova) for all clinical trials conducted with industry sponsors or contract resource organizations (CRO's).
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• Manages and prioritizes study start up activities for clinical research sites contracting with Frenova Renal Research.
• Collects study specific essential documents to include, but not limited to, Form FDA 1572, financial disclosure forms, protocol signature pages, CVs, licenses, and Good Clinical Practice (GCP) training.
• Prepares submissions to Institutional Review Boards (IRBs) and submits to the board on behalf of each clinical research site contracting with Frenova, as applicable.
• Ensures each site meets project-specific timelines for processing of all regulatory documents.
• Maintains FDA and GCP required regulatory documentation for individual clinical research site contracting with Frenova.
• Maintains updated credentials and other critical documentation ensuring compliance for Principal Investigators, Sub-Investigators, clinical research coordinators, and other relevant staff, as applicable, within each site.
• Prepares submissions to Institutional Review Boards (IRBs) and submits to the board on behalf of each clinical research site contracting with Frenova, as applicable.
• Ongoing coordination of document processing throughout the duration of a study for all clinical research sites contracting with Frenova.
• Ensures regulatory documentation is compliant with Standard Operating Procedures (SOP's) in format and content.
• Reviews regulatory documents for completeness and accuracy.
• Initiates improvements, processes, and forms to enhance efficiency and quality of work.
• Ensures research-related regulatory approvals are obtained and filed.
• Liaises with sponsors and CRO's as needed for completion of regulatory documents as well as internal and external Fresenius personnel.
• Under general supervision, follows established company policies and procedures and applied acquired job skills.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assists with various projects as assigned by direct supervisor.
• Must maintain confidentiality and a high degree of sensitivity inside and outside of the company.
• Performs other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
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.
• Day to day work includes desk and personal computer work and interaction with study sponsor, CRO and SMO staff.
• Occasional travel to investigator meetings, physician offices and regional and corporate meetings, up to 20% of the time required.
• Availability outside of office hours required as needed (through e-mail, phone, etc.).
SUPERVISION:
• None
EDUCATION AND REQUIRED CREDENTIALS:
• Bachelor's Degree or an equivalent combination of education and experience
• Participation in and documentation of training on ICH GCP Guidelines and FDA regulations for clinical trials in the drug, biotech or device industry.
EXPERIENCE AND SKILLS:
• Minimum of 3 years related experience.
• Advanced computer proficiency, especially MS Office.
• Ability to multi-task, work independently, take initiate, complete tasks to deadline, and exhibit diplomacy and problem-solving skills.
• Excellent oral and communication skills.
• Proficient in the use of an electronic Clinical Trials Management System preferred.
• Demonstrated knowledge of FDA, ICH GCP and local regulations. Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance required.
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.
