Job Details

Position purpose

The Regulatory Associate is a specialized research professional working with and under the direction of the Regulatory Manager. The primary responsibility of the Regulatory Associate is to assist the Regulatory Manager with regulatory conduct and compliance of research studies. The Regulatory Associate supports and facilitates the creation, distribution, filing and quality review of all essential documents related to studies assigned.

Responsibilities/Duties/Functions/Tasks:

• Compiles and collects required study and general research compliance training documents
• Uploads files and routes essential documents for signature
• Maintain and utilize interim regulatory reports to ensure accurate documentation is being retained
• Creates and owns the regulatory binder upkeep end to end for studies assigned
• Compile and prepare materials for regulatory submission to regulatory agencies and IRBs
• Review clinical protocols and study start up requirements to ensure timely collection and distribution of data needed for regulatory submissions
• Support regulatory preparation for internal or external audits
• Identify relevant guidance documents as needed for accurate regulatory compliance
• Occasional travel to research clinics
• Assists local site teams, as needed in communication of study requirements to all individuals involved in the study.
• Maintains the integrity of assigned electronic files (or paper files) in Clinical Trial Management System
• Prepares regulatory files prior to monitoring visits and reviews monitor visits for action item completion of regulatory needs for all assigned trials
• Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and company policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents.
• Aids the Study Team in maintaining effective and ongoing communication with sponsor, clinical research coordinators, managers, directors and PI during the course of the study.
• Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
• Responsible for IRB initial submissions and updating annual IRB reports
• Reports any site non-compliance or training needs to regulatory manager
• Review and submits ICFs to IRB for study start up
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with company compliance efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
• Other duties as assigned.

Qualifications

Education: Undergraduate College Degree

Experience: Minimum two years of Clinical Research experience required. Regulatory experience preferred

Other Requirements: Occasional travel may be required

Performance Requirements:

• Knowledge of grammar, spelling, and punctuation.
• Skill in operating office equipment.
• Skill in answering the phone and responding to questions.
• Skill in time management, prioritization, and multitasking.
• Skill in writing and communicating effectively.
• Ability to work under pressure, communicate and present information.
• Ability to read, interpret, and apply clinic policies and procedures.
• Ability to identify problems, recommend solutions, organize and analyze information.
• Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Position may be office based, hybrid, or remote depending on studies assigned.

Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.