Clinical Research Associate 2 at Personalis, Inc.

<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited.&nbsp;Personalis is based in Fremont, California.</span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Days Onsite: Monday &amp; Tuesday (Hybrid)</strong></span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Summary:<br></strong></span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">The Clinical Research Associate is responsible for managing clinical operations projects, which includes biospecimen management, GCP documentation, and compliance requirements related to Personalis clinical research studies and CRO partnerships. This individual will require an understanding of oncology molecular testing using Next Generation Sequencing (NGS) platforms, medical devices, and will interact with external partners to execute clinical operations, monitoring, regulatory, and clinical quality documentation.</span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Responsibilities:</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Lead clinical operations activities.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Manage Clinical study operations (internal and external) in coordination with CRO, IRB, regulatory, and quality teams.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Support the program sponsor in preparation of clinical study operations.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Collaborate in the execution of clinical validation studies to support clinical programs.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Oversee clinical site initiation, monitoring, and closeout activities.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Participate in Site Monitoring activities.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Manage CRO partnerships.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Manage the clinical study biospecimen repository and data management.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Track Timelines, Milestones, Deliverables, Resources, and Costs.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ensure internal and external milestones, deliverables, and obligations are met.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Partner collaboratively with the Regulatory and Quality teams to ensure that all internal SOPs and compliance documentation meet quality standards.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Take ownership of key partner-related issues and work with appropriate internal teams to resolve them.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Requirements:<br></strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">BS or MS in biological science, computer science or a related field.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Minimum of 2+ years working in industry or academics in clinical operations for medical devices.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experienced with products in a clinical or regulated environment (such as with IRB, FDA, CAP/CLIA etc).</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) organization and structure.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience with Onsite or Remote clinical study monitoring</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience with Case Report Form (CRF) creation</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Proficiency in MS Word, Excel, and PowerPoint.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience with Good Clinical Practice (GCP) and clinical quality compliance.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Demonstrated history of successfully managing multiple concurrent initiatives.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong interpersonal skills, collaboration, and problem-solving with colleagues.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong communication and excellent written and oral skills.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Detail-oriented, with solid organization and time management skills.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Able to work under pressure, self-starter, and team player.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Travel 0-25%.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Desired Experience:</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">3+ years working in industry or academics in clinical operations for medical devices.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">2+ years program management experience</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experienced with products for ex-US regulatory agencies (EU, Japan, Australis etc).</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) setup and validation.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience Metadata Statistical analysis.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">The hiring range for this position is <strong>$120,000 </strong>to <strong>$145,000</strong> per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.</span></p> <p style="text-align: left;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.</span></p> <p style="text-align: left;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Protecting Our Candidates:</strong> At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from <strong>@</strong><a href="http://personalis.com" target="_blank"><strong>personalis.com</strong></a> email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.</span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><em>Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical,&nbsp;dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)&nbsp;<br><br>#LI-KK1 #LI-Hybrid</em></span></p>