Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
Clinical Trial Assistant
Location
United States
Posted
1 day ago
Salary
$34K - $44K / year
Seniority
Mid Level
Job Description
Clinical Trial Assistant
Iovance Biotherapeutics, Inc.
• Adhere to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines. • Assist in contacting investigator sites to provide study specific information. • Ensure receipt, completeness and accuracy of clinical and administrative documents. • Coordinate distribution and shipment of study-related materials. • Coordinate investigator site/payment as needed. • Maintain telephone contact with sites, contract research organization personnel, vendors and CRAs as needed. • Facilitate flow and maintenance of correspondence with sites. • Attend clinical project team meetings and takes minutes. • Contract, invoice and budget management and tracking. • Assist in coordination of study initiation documentation materials. • Responsible for compiling/QC checking/generating copies of clinical documents that are intended for submissions including 1572s (original and updated), Informed Consent Form, Protocol and Investigator’s Brochure. • Coordinate distribution of study team materials and meeting minutes. • Draft and prepare documents for mass mailings (e.g., protocol amendments). • Assist with preparation of presentation materials. • Maintain central registry of contact information for clinical sites, contract research organizations, vendors and CRAs. • Set up teleconference calls with sites and team and record minutes. • Maintain central monitoring calendar for all site visits. • Create and maintain Central Clinical files. • Perform administrative and clerical duties. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.
Job Requirements
- 2 + years of pharmaceutical or biotech-related/clinical research, oncology or research experience.
- Excellent verbal and written communication skills.
- Attention to detail.
- Demonstrated ability to work independently and exhibit initiative.
- Computer literacy required (MS word, MS Excel, MS PowerPoint and MS Project)
Benefits
- N/A
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