Clinical Research Associate

The in-house CRA will perform clinical research duties to promote the successful clinical development of HiberCell's proprietary compound. As assigned, responsibilities may include, but are not limited to:

• Tracking subject recruitment and progression as well as selected study data points
• Assisting with preparation/collection, review, and tracking of regulatory documents for US and global studies
• Creating and/or reviewing informed consents, coordinators' manual, pharmacy manual, source documents, and other documentation required for the conduct of a clinical trial
• Assisting with the creation and maintenance of the trial master file
• Reviewing clinical data in-house and communicating with study site personnel to resolve data queries
• Ordering clinical supplies for assigned studies and maintaining accurate records of drug accountability/compliance across the study(s)
• Participating in the development of protocols and case report forms
• Conducting/participating in co-monitoring and/or auditing visits
• Liaising with vendors and investigative site staff

Candidate Qualifications:

Preference will be given to candidates with the following qualifications:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
• Minimum two years of relevant experience in pharmaceutical/biotechnology setting and oncology research experience
• Thorough knowledge of ICH Guidelines and GCP/CFR
• Understanding of serious adverse event reporting process
• Ability to work independently
• Excellent computer skills with good working knowledge of a range of computer packages including Word and Excel
• Excellent verbal and written communication skills and detail oriented

Travel Requirements:

• Minimal travel may be required.