[Hiring] Regulatory Research Assistant @CenExel

Role Description

Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to 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 RealTime 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 relevant regulatory document issues.
• Ensures Clinical Conductor regulatory information is current.
• Participates in team meetings and complies with training requirements.
• Assists sponsors/CRO’s as needed.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned.

Qualifications

• Must be able to effectively communicate verbally and in writing.
• Minimum: High School graduate or equivalent.
• Minimum of 1 year of related experience in clinical research.
• 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.

Requirements

• 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.

Benefits

• Highly competitive compensation: $20.00 - $22.00/hour (depending on education, experience, and skillset).
• Generous benefits package to full-time employees after 30 days of employment including:
• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Insurance
• 401k