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, with radiotherapy that has a large number of side effects. Come be a contributing team member in the development of a first-in-class treatment to selectively destroy cancer cells!
Role & Responsibilities:
Aura is hiring for a 1099 Contract CRA in the Mountain or Pacific region. The Contract Regional CRA candidate will be responsible for overall site management including, but not limited to site qualification, initiation, interim monitoring, and trial close-out activities for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Responsibilities also include ensuring the quality of data submitted from trial sites and the timely submission of data, including appropriate reporting and follow-up for all safety events, by site personnel, as well as Investigator Site File review and investigational product accountability. This particular role will focus on Ophthalmology, specifically choroidal melanoma.
- Conduct site qualification, initiation, interim and close-out visits at clinical research sites per sponsor schedule as detailed in the trial’s Monitoring Plan
- Initiate sites including training site personnel on all trial specific procedures
- 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, and return
- Perform total trial management of assigned trial sites to ensure the adherence to protocol requirements and data collection/database closure within the established trial timelines
- Communicate site update information to Sponsor Clinical Team contact
- Perform site close-out including final CRF review and SDV, final discrepancy management, final drug accountability/reconciliation, final drug return/destruction, and archiving of trial documents
- Maintain regular communication with sites
- 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
- At least 5 years of field monitoring experience required, experience with Ophthalmology strongly preferred; oncology 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 per region assigned (Mountain or Pacific region); expectation is for 2-3 monitoring visits per month, with the understanding that visit demands are based on a variety of factors and require flexibility. Estimate between 10-25 hours/week depending on travel and site needs.
Remote-based position; Mountain or Pacific location 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.