At Aura Biosciences, we are developing a new class of therapies based on an expressed virus-like particle bioconjugate to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.
Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes. Come help develop a first-in-class treatment to selectively destroy cancer cells!
Role & Responsibilities:
This position will provide administrative and clinical trial support to the Clinical Operations team in completion of all required tasks to meet departmental and project goals and support the ongoing conduct of clinical trials in our lead program in ocular melanoma.
Reporting to the Director, Clinical Operations, the Clinical Trial Associate will be responsible for assisting in the management of various aspects of clinical trial conduct with subject matter experts including clinical development, contract vendors, and regulatory to achieve clinical trial goals on time and within budget.
Assist in the development and distribution of clinical trial documents including informed consent templates, source documents, and Study Procedure Manual contents.
Set up, organize and maintain (ensure contents are current) Trial Master Files, including preparation for internal/external audits, final reconciliation and archiving.
Assist in developing and implementing clinical processes and procedures including site budgets, investigator payments, protocol compliance reporting, and investigational product management.
Develop and regularly update project tracking tools, including subject recruitment, study supplies, and investigational product.
Provide assistance to regional Clinical Research Associates (CRAs) includingcontacting clinical sites for specific requests as needed (e.g. enrollment updates, missing documentation, meeting arrangements, etc.), tracking scheduled site visits and site visit report submissions through finalization.
Act as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders
Assist in the facilitation and management of productive team communication and collaboration, both internally and externally and prepare minutes of these meetings as needed.
Assist in the review of monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed.
Assist with oversight of study metrics and compliance and present/report issues, progress and escalate monitoring trends or findings to the study manager.
Life sciences bachelor’s degree or certification in a related allied health profession from an accredited institution (e.g. nursing, medical or laboratory technology) or equivalent
2-4 years of experience in clinical trial research (e.g., study coordinator, regulatory operations, monitor), including electronic TMF document management experience. Experience in ophthalmology and/or oncology preferred.
Understanding of GCP and regulatory requirements as well as a working knowledge of clinical research documents, their contents and purpose.
Strong organizational/prioritization skills for the management of multiple tasks with meticulous attention to detail.
Strong written and verbal communication skills.
Demonstrated proficiency with Microsoft office programs (e.g. Microsoft Word, Excel, PowerPoint, Outlook) and web-based data entry platforms.
Candidates should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.
Based in the Company’s North Cambridge office, with minimal travel, if any, required.
Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.