Regulatory Assistant

About Cen Exel Cen Exel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise well-respected, long-standing facilities with specialty areas including Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each center has extensive experience with complex early phase trials and in-patient capability. We focus on quality people, teamwork, and experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, Cen Exel Clinical Research provides competitive compensation and a generous benefits package to full-time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k.

Position Summary Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies, in accordance with site SOPs, ICH, GCP, and FDA guidelines.

Essential Responsibilities and Duties

• Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines.
• Uploads regulatory documents with Real Time eDOCs System and files in paper binders as necessary.
• Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums.
• Tracks submissions and ensures timely filing of documents.
• Obtains CVs (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents.
• Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff.
• Assists in obtaining necessary signatures from investigators.
• Works closely with study sponsor/CRO and key clinical trial personnel on regulatory document issues.
• Ensures Clinical Conductor regulatory information is current.
• Participates in team meetings and complies with training requirements.
• Assists sponsors/CROs as needed.
• Supports and ensures strict adherence to best practices, FDA CFR, ICH, GCP, Cen Exel SOPs, site working practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work and are not all inclusive.

Education/Experience/Skills

• Must be able to effectively communicate verbally and in writing.
• Minimum High School graduate or equivalent.
• Minimum of two years of related experience.
• Must be self-directed and able to work with minimal supervision.
• Able to take a flexible approach to shifting priorities.
• Motivated to work consistently in a fast-paced and rapidly changing environment.

Working Conditions

• Indoor, Office environment.
• Essential physical requirements include sitting, typing, standing, and walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.
• Ability to work overtime, weekends, and/or holidays as needed.
• Ability to travel as needed.
• Remote work arrangement depending on location.

Cen Exel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or other protected status.