Job Description

Job Title: Clinical Research Associate

Location: Onsite in Boulder, CO

About the Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role

The Clinical Research Associate (CRA), under Clinical Operations, will support the execution of clinical trials conducted under an Investigational Device Exemption, including data monitoring, TMF maintenance, and support for Clinical Operations-based inquiries from the CRO or study sponsor. The CRA will also support the Research Project Coordinator in management of sample logistics to ensure quality testing services for translational research and investigator-initiated trials. This role will work collaboratively with Medical Affairs, Quality Assurance, Regulatory Affairs, and Production as well as with external stakeholders such as biopharmaceutical study sponsors, CROs and study vendors.

What You Will Do

• Participate in planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical trials.
• Ensure studies are conducted and documented in accordance with the study protocol, study plans, standard operating procedures, good clinical practices, and other applicable regulatory requirements.
• Facilitate the execution of startup activities and study maintenance (eg, collection of regulatory documents and ethics submissions, shipment of supplies and equipment, vendor training/access to vendor portals); to ensure site readiness and study maintenance.
• Responsible for in-house and clinical site monitoring deliverables (e.g., performing source data verification, identifying protocol deviations and safety events, conducting site training, and providing written follow-up requests to correct any issues identified).
• Generate monitoring reports.
• Establish and maintain biobanking program.
• Coordinate and track sample shipments with biopharma partners, research institutions, and clinical research organizations (CROs); including reconciling manifests and total number of samples received.
• Compare contracted sample numbers with the number of received samples and reported results and integrate all sample information into Salesforce, Foresight's Customer Relationship Management system (CRM).
• Work to continuously improve the laboratory services process and identify opportunities for enhancement, collaborating with operational and engineering teams to develop solutions and facilitating delivery of workflow improvement.
• Monitor aggregate data relating to clinical trial testing, including specimen acceptance rates and QC failure rates.
• Manage and resolve specimen or data issues with Sponsor, CRO, or other study partners.
• Participate in partner meetings, as needed.
• Update all relevant tracking systems and logs on an on-going basis.
• Maintain the internal trial master file.
• Maintain and update clinical operations documents that govern trial conduct.

What You Will Bring

• Bachelor's or Master's degree in relevant field.
• 5+ years' experience in Clinical Operations, including monitoring and TMF management.
• Certification in Good Clinical Practice and Human Subjects Research.
• Laboratory operations experience is preferred.
• Excellent written and verbal communication skills.
• Detail-oriented and able to manage multiple projects at the same time.
• Proficiency in Microsoft products.
• Strong strategic thinking and problem-solving skills.

Physical and Mental Requirements, Working Conditions

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
• Travel at least quarterly to Boulder, CO.
• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

Compensation and Benefits

This role is hiring at an annual salary of $115,000 - $130,000 and is eligible for bonus and equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Tags

Full time, Worldwide, Flexible hours,

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