Sr. Clinical Trial Associate (CTA) chez Aura Biosciences

About Aura: 

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Role & Responsibilities:
The Senior Clinical Trial Associate (Sr CTA) will provide clinical trial management support to the Clinical Development Operations team in completion of all required tasks to meet departmental and project goals. The role will support the ongoing conduct of clinical trials in Aura’s lead program in ocular melanoma, as well as other trials in the future, and offers the opportunity to gain deep exposure to clinical trial operations in a biotech setting, with potential for career advancement into Clinical Trial Manager roles.

Essential functions:

• Reporting to the Executive Director, Clinical Development Operations, the Sr. CTA will play a key role in supporting the planning, execution and oversight of clinical trials. This role partners closely with clinical development, contract vendors, and regulatory teams to ensure clinical trial milestones are met on time and within budget.
• Support 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.
• Support the development and implementation of 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) including contacting 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.
• Support the facilitation and management of productive team communication and collaboration, both internally and externally and prepare minutes of these meetings as needed.
• Support 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.
• Monitor study metrics and compliance and present/report issues, progress and escalate monitoring trends or findings to the study manager
• Coordinate site materials and support documentation distribution to Investigators.

Qualifications:
The ideal candidate will offer:

• 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.
• Strong 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.
• Comfortable working in a dynamic, high-growth biotech environment where adaptability and cross-functional collaboration are essential.
• Demonstrated proficiency with Microsoft office programs (e.g., Microsoft Word, Excel, PowerPoint, Outlook) and web-based data entry platforms.
• A passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.

Salary & Benefit Information:

Salary Range: $100,000/yr - $130,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance