The Clinical Research Coordinator (CRC) is responsible for overseeing and coordinating all aspects of clinical trials, ensuring that studies are conducted in compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. The CRC will act as the primary liaison between the clinical research team, patients, and external stakeholders, ensuring the efficient and timely execution of clinical research projects.

Responsibilities: Study Coordination: Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment. Schedule and oversee patient visits, ensuring timely collection of data and samples in accordance with the study protocol. Oversee site initiation, monitoring, closeout activities, and equipment calibration to ensure compliance with study protocols and regulations. Maintain study documentation, including case report forms, consent forms, and other essential study records. Review monitoring follow-up letters to ensure timely completion and resolution of identified issues. Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs). Manage the receipt, shipment, and storage of study drug and trial samples. Ensure proper handling and storage of study materials, medications, and biological samples. Generate invoices for study sponsors as applicable or assigned. Patient Interaction: Serve as the main point of contact for participants, answering questions and providing information regarding study protocols, treatment options, and expected outcomes. Ensure patients understand the study’s risks, benefits, and requirements by assisting in the informed consent process. Monitor and document patient progress throughout the study, ensuring that their safety and well-being are maintained. Data Management: Enter, maintain, and monitor study data in the clinical trial management system (CTMS) and other relevant databases. Perform quality control checks to ensure the accuracy and completeness of data. Collaborate with trial site staff, sponsor or CRO to resolve any discrepancies or issues with study data. Regulatory Compliance: Stay current with federal and global regulations, including ICH-GCP and FDA guidelines, and ensure the study's adherence to applicable regulatory requirements, as well as sponsor-specific requirements. Assist with the preparation and submission of study protocols, amendments, and regulatory documents to the Institutional Review Board (IRB). Prepare site materials, including training materials, regulatory binders, manuals, and support documentation, ensuring alignment with regulatory guidelines and ethical standards. Conduct training for study staff on regulatory requirements and ensure compliance with study protocols. Maintain regulatory binders and drug accountability documents for each study. Archive all documentation at the end of the study per Sponsor and FDA-required timelines. Study Team Collaboration: Work closely with the Principal Investigator, Clinical Research Manager, and other research staff to ensure the study’s success. Communicate with sponsor representatives, providing regular updates on study progress and patient enrollment. Assist with study recruitment strategies and participate in outreach activities.

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The role reports to the Director of Clinical Operations, Dennis McHugh. This role will be a Remote role with occasional travel, as required, to our Brisbane, California headquarters.

Responsibilities:

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials.
• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required.
• Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.

Requirements:

• Minimum Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent.
• 3+ years’ experience in a clinical trials research environment required, with specific in vitro diagnostics study experience.
• General knowledge of regulatory requirements & GCP.
• Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks.
• Strong interpersonal, collaborative, and time management abilities.
• Excellent organizational skills; accurate and detail-oriented.
• High proficiency in Veeva Vault and Medrio.
• Strong spoken and written communication skills.

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