Clinical Trial Assistant; CRA U.S

Clinical Trial Assistant (CRA) – U.S. Based

Ice Cure Medical, an innovative medical device company in the field of cryoablation for the destruction of tumors, is seeking a clinical trial assistant (CRA) who is based in the U.S. The ideal candidate will have a background in the health sciences or medical device field and preferably have easy access to the Chicago, Atlanta, or Charlotte airport hubs.

• Engineer, Biologist, Nurse or similar profile.
• GCP training and experience and CRA Certificate.
• 2+ years of experience as a clinical research associate.
• Knowledge of the medical device industry, terminology, and practices.
• Strong verbal and written communication skills.
• Proficient computer skills:
  Microsoft Office Word, Excel, and PowerPoint.
• Available to travel, and ability to manage travel schedules, preferably with easy access to the Chicago, Atlanta or Charlotte airport hubs

• Creating and writing trial documentation (i.e; protocol, CRF design, clinical study report writing, and NTFs).
• Coordinates and facilitates monitoring and auditing visits. Onsite and remote initiation, monitoring, and closeout of clinical trials according to regulatory requirements (Responsible for raising study queries, data cleaning, checking patient selection, informed consent process, and eligibility as possible prior to procedure).
• Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Ongoing, daily basis communication with sites.
• Training site staff on protocol requirements, proper source documentation, and case report form completion.
• Maintaining clinical data systems.
• Regulatory site file and trial master file handling.
• Coordinates and administers research study associated activities
• Maintain study records, including managing records Report any adverse event or serious event or ethical problem related to the study or related to the device, to the study manager.
• Ordering, tracking, and managing IP and trial materials.
• Report and document any customer complaint related to the study procedure.

Reports to:
Clinical Trial Manager