At Aura Biosciences, we are developing a new class of therapies based on virus-like particles (VLPs) 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 not optimally managed today.
Our lead program in choroidal melanoma is designed to selectively kill cancer cells in the choroid and our expectation is that this product will be utilized as a first-line therapy, as the existing radiotherapy treatment options have a large number of side effects. Aura is expanding its targeted therapy to other oncology indications and is currently initiating a program in bladder cancer. Come be a contributing team member in the development of a first-in-class treatment to selectively destroy cancer cells!
Role & Responsibilities:
Reporting to the Associate Director, Clinical Operations, the Lead Clinical Research Associate (CRA) candidate will be responsible for oversight and management of CRA personnel and activities, including, but not limited to conducting oversight monitoring visits to ensure activities for studies are conducted and monitored in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Aura Standard Operating Procedures (SOPs). The candidate will work closely with the Clinical Trial Lead regarding all monitoring related activities, provide oversight and management of contract regional CRA team members, and provide support and training to CRAs.
- Conduct routine oversight monitoring visits to oversee the performance of contract CRAs and site activities to ensure quality standards are met and activities are completed in accordance with company SOPs and trial Monitoring Plan
- Support Clinical Trial Leads in the ongoing management of trial activities, specifically with report review, monitoring visit metric tracking, and protocol compliance tracking
- Review and update procedures and processes to ensure quality of monitoring activities
- Conduct remote, centralized review of clinical trial data
- Perform co-monitoring visits in case of persistent site issues
- Escalate recurrent major quality issues to the Clinical Trial Lead and/or Associate Director, Clinical Operations
- As needed, conduct site qualification, initiation, interim and close-out visits at clinical research sites per sponsor schedule, as detailed in the trial Monitoring Plan
- Conduct source document verification (SDV) for compliance, patient safety, and veracity of data
- Review CRFs using electronic data capture systems and assist sites with data query resolution
- Write site visit trip reports
- Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g., IRB / IEC trial approval, informed consent, etc.)
- Perform drug accountability/reconciliation
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
- Remain current and knowledgeable in the therapeutic areas assigned
- Maintain a current knowledge of Sponsor Standard Operating Procedures (SOPs), ICH guidelines and FDA regulations
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
- 8 – 10 years of field monitoring experience required, experience with Ophthalmology strongly preferred; oncology recommended; clinical audit experience also recommended
- Solid understanding and application of GCP, GLP and ICH requirements
- Excellent written and oral communications skills
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
- Willingness to travel throughout the US; expectation is for approximately 1-2 monitoring visits per month, with the understanding that travel requirements are based on a variety of factors and require flexibility
Remote-based position; Central location with easy access to major airport strongly preferred
How we Work:
Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs. We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.