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 base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If the role is non-exempt, overtime pay will be provided consistent with applicable laws. In addition to the salary range listed above, total compensation also includes generous equity, performance-related bonus(es) for eligible employees, and the following benefits.

Benefits

• Medical, dental, and vision insurance for you and your family, with employer contributions to Health Savings Accounts

• Pre-tax accounts for Health FSA, Dependent Care FSA, and commuter expenses (parking and transit)

• 401(k) retirement plan with employer match

• Paid parental leave (up to 24 weeks for birth parents and 20 weeks for non-birthing parents), plus paid medical and caregiver leave (up to 8 weeks)

• Paid time off: flexible PTO for exempt employees and up to 15 days annually for non-exempt employees

• 13+ paid company holidays, and multiple paid coordinated company office closures throughout the year for focus and recharge, plus paid sick or safe time (1 hour per 30 hours worked, or more, as required by applicable state or local law)

• Mental health and wellness support

• Employer-paid basic life and disability coverage

• Annual learning and development stipend to fuel your professional growth

• Daily meals in our offices, and meal delivery credits as eligible

• Relocation support for eligible employees

• Additional taxable fringe benefits, such as charitable donation matching and wellness stipends, may also be provided.

About the Team

The Safety Systems team is in need of a Technical Program Manager to streamline our full safety stack and integration of various safety research and mitigations into ChatGPT and our API. This role is critical for driving safe deployment of our new models, synthesizing inputs from multiple stakeholders , ranging across research, product, engineering, legal, and policy , and ensuring all the risks are effectively and properly monitored, mitigated, or resolved.

About the Role

As a Safety Engineering TPM, you will be responsible for critical tasks ranging from tracking safety engineering progress and risk tables to overseeing critical data infrastructure programs, acting as the connective tissue to enhance the deployment of OpenAI’s safety system. Additionally, you will create and execute a compute roadmap for your team to ensure that our top priorities are resourced while taking advantage of new opportunities to make key safety infrastructure investments. Your primary focus will be to build a foundational layer to support the safety of all of our models and products.

Responsibilities

• Manage key risk areas and corresponding stakeholders.

• Work directly with safety engineers, engineering managers, and product managers to build common safety infrastructure.

• Manage data and compute infrastructure, including data residency and capacity planning.

• Design and run key internal programs, including incident management and processes for regularly updating our safety mitigations.

• Prioritize and manage a portfolio of infrastructure requests from other internal teams.

Requirements

• Have an undergraduate or graduate degree in computer science or computer engineering, or a demonstrated track record of engineering expertise.

• Have an extensive track record of successfully delivering high-profile, complex technical projects against tight deadlines.

• Are technically adept, and have effectively partnered with engineering and fundamental research teams of the highest caliber.

• Have expertise in designing and implementing simple, scalable processes that solve complex problems.

• Are relentlessly resourceful and thrive in ambiguous, fast-paced environments.

• Have strong knowledge of content integrity and moderation, including industry best practices and regulatory guidelines.

• Have exceptional written and verbal communication skills.

• Care about AGI safety.

About OpenAI

OpenAI is an AI research and deployment company dedicated to ensuring that general-purpose artificial intelligence benefits all of humanity. We push the boundaries of the capabilities of AI systems and seek to safely deploy them to the world through our products. AI is an extremely powerful tool that must be created with safety and human needs at its core, and to achieve our mission, we must encompass and value the many different perspectives, voices, and experiences that form the full spectrum of humanity.

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