26 Clinical Research Associate (I/II/III) Jobs in San Mateo, CA
PrognomIQ is Hiring a Clinical Research Associate (I/II/III) Near San Mateo, CA
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 RoleAs 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
- 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%)
Job Summary
Full Time
$85k-116k (estimate)
04/06/2023
07/16/2024
prognomiq.com
<25
The job skills required for Clinical Research Associate (I/II/III) include Clinical Research, Clinical Trial, Clinical Operations, Organizational Skills, Microsoft Office, Data Capture, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Associate (I/II/III). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Associate (I/II/III). Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Associate (I/II/III) positions, which can be used as a reference in future career path planning. As a Clinical Research Associate (I/II/III), it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate (I/II/III). You can explore the career advancement for a Clinical Research Associate (I/II/III) below and select your interested title to get hiring information.
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