Clinical Regulatory Assistant

GI Alliance is seeking an experienced Clinical Regulatory Assistant.

Duties of this position include, but are not limited to, the following:

Position purpose

The Clinical Regulatory Assistant is a specialized research professional working with and under the direction of the Clinical Regulatory Supervisor. The primary responsibility of the Clinical Regulatory Assistant is to assist the Clinical Regulatory Supervisor with conduct and compliance of research studies. The Clinical Regulatory Assistant supports and facilitates the daily clinical trial activities and plays a supportive role in the conduct of the study.

Responsibilities/Duties/Functions/Tasks:

• Compiles and collects required compliance training documents
• Uploads files and routes documents for signature from GI Alliance Research personnel
• Maintain and utilize interim regulatory reports to ensure accurate documentation is being retained
• Compile and prepare materials for submission to regulatory agencies
• Review clinical protocols to ensure collection of data needed for regulatory submissions
• Participate in internal or external audits
• Identify relevant guidance documents
• Occasional travel to other GI Alliance Research clinics
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines
• Assists Study Team, as needed in communication of study requirements to all individuals involved in the study.
• Maintains the integrity of assigned electronic files in Clinical Trial Management System
• Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance Research 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, research participants, Director and PI during the course of the study.
• Works with the Study Team to manage the day to day activities of the study including problem solving and communication.
• 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.
• 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 GI Alliance Research compliance and monitoring 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: High school diploma or equivalent. Some college preferred.

Experience: Minimum one year 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.

GI Alliance is an Equal Opportunity Employer. We are committed to creating an inclusive, welcoming, and equitable work environment. Our company values and celebrates the diversity of our physicians, staff and patients. We firmly believe our service is greatly enriched by our diversity of thought, experience, perspective, culture, and background.

Please Note: All job offers are contingent on the successful completion of pre-employment criminal history check.

NOTE: ALL APPLICATIONS MUST BE COMPLETED IN FULL FOR CONSIDERATION.

No phone calls or agencies, please.

EEO/AA-M/F/disabled/protected veteran