Clinical Trial Assistant

This is a fully remote position, open to applicants in United States.

📋 Description

• Comply with Clinical Standard Operating Procedures and adhere to Good Clinical Practice ICH Guidelines.

• Assist in reaching out to investigator sites to deliver study-specific information.

• Ensure the receipt, completeness, and accuracy of clinical and administrative documents.

• Coordinate the distribution and shipment of materials related to the study.

• Manage investigator site payments as required.

• Maintain telephone communication with sites, personnel from contract research organizations, vendors, and CRAs as necessary.

• Facilitate the flow and upkeep of correspondence with sites.

• Participate in clinical project team meetings and take minutes.

• Oversee contract, invoice, budget management, and tracking.

• Assist in the coordination of materials for study initiation documentation.

• Responsible for compiling, QC checking, and generating copies of clinical documents intended for submissions, including 1572s (both original and updated), Informed Consent Form, Protocol, and Investigator’s Brochure.

• Coordinate the distribution of materials for the study team and meeting minutes.

• Draft and prepare documents for mass mailings, such as protocol amendments.

• Assist with the preparation of presentation materials.

• Maintain a central registry of contact information for clinical sites, contract research organizations, vendors, and CRAs.

• Arrange teleconference calls with sites and the team, recording minutes as needed.

• Maintain a central monitoring calendar for all site visits.

• Create and uphold Central Clinical files.

• Perform various administrative and clerical duties.

• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Carry out miscellaneous duties as assigned.

⛳️ Requirements

• Minimum of 2 years of experience in pharmaceutical or biotech-related clinical research, oncology, or similar fields.

• Exceptional verbal and written communication skills.

• Strong attention to detail.

• Proven ability to work independently and demonstrate initiative.

• Proficiency in computer applications, including MS Word, MS Excel, MS PowerPoint, and MS Project.

🏝️ Benefits

• N/A