Clinical Research Associate (I/II/III) - PrognomIQ

Who we are

At PrognomiQ, we aim to transform healthcare by generating and using systems biology data to develop and commercialize tests for early detection and treatment of cancer and other complex diseases.  PrognomiQ leverages leading proteomics technology, including the Proteograph product suite from Seer, as part of a multi-omics platform that provides an unprecedented molecular view of health and disease. We are a team of experienced and accomplished scientists supported by a group of leading investors in healthcare and technology.

Would you like to be part of a team that is at the leading edge of molecular data generation and analyses that changes how cancer and other complex diseases are detected and treated? Do you aspire to be on the cutting edge of ‘omics technology and data science development? Are you looking to be part of a world class scientific team striving to bring disruptive solutions to market? Do you thrive in an environment of cross-functional disciplines and innovation?

Description of the role

As a CRA in PrognomiQ’s Clinical Operations team, you’ll be critical in providing site start up, training, management, and monitoring activities that will lead to the successful execution of clinical studies. You’ll contribute to the development of necessary study documents including project plans and clinical protocols, ensuring that clinical samples are collected according to strict IRB protocols. You’ll apply your project coordination and organizational skills in order to manage multiple projects/sites simultaneously and independently and ensure that these protocols are followed.

PrognomiQ is combining the breakthrough advances in proteomic profiling made possible by Seer Bio’s Proteograph Product Suite with cutting edge next generation sequencing (NGS) technologies in order to revolutionize non-invasive diagnostics. Highly motivated candidates with a track record of site management, significant monitoring experience, and who are keen about the life-saving potential of innovative new diagnostic technologies such as yourself will be critical to our success.

Duties

• Contribute to development of study project plans and critical study documents, including informed consent forms, case report forms, required sample collection and handling protocols and site training materials
• Contribute to development of study project plans
• Perform site identification, qualification and startup activities, including regulatory document review, IRB submission and document review, and ensure timely shipment of study supplies, including regulatory binders and sample collection supplies
• Work with vendors to ensure that all study services comply with the study plan and budget; this may include clinical research organizations (CROs), electronic data capture vendors (EDC), and suppliers
• Mentor junior CRA and CTA on the team
• Implement initial and ongoing site training in the conduct of the study and the sample collection and handling procedures
• Perform ongoing site management activities, including assessing adherence to eligibility criteria, sample collection and handling instructions and other study procedures, identifying and implementing a plan for retraining or ongoing training needs, ensuring that sites have continuous sample collection supplies, and facilitating ongoing communication
• Perform data management activities, which includes generating queries and document their resolution in a manner consistent with established timelines
• Execute all site monitoring activities; ensure subject informed consent and eligibility, data quality and integrity and adherence to applicable regulations

Requirements

• Bachelor’s Degree required (life science preferred) or certification in a related allied health profession such as nursing, medical or laboratory technology
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical study management
• Understanding of study-specific clinical specialty and standard of care/patient management within that specialty
• Sponsor Experience required
• Experience monitoring studies for diagnostic product development or medical device
• Excellent Microsoft Office (Excel, PowerPoint, Word), project management and clinical trials software skills
• Exceptional attention to detail
• Ability to work independently with minimal supervision
• Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication as well as ability to communicate effectively with clinical study site investigators and staff, and with internal teams
• Strong and collaborative work ethic
• Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
• Highly organized, and strong proficiency in documentation skills
• Must be willing to travel (up to 70%)