Careers

Contract Regional CRA – East Coast/Midwest

About Aura:

At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  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 to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Title:

Contract Regional CRA – East Coast/Midwest

Location:

Remote-based position; Midwest or East Coast location strongly preferred

Summary:

Aura is hiring for a 1099 Contract CRA in the East Coast/Mid-West 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.

Essential Functions:

  • 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.

Qualifications:

  • 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 (East Coast and Midwest); 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.

 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.

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