Stanford Radiology is committed to providing exceptional patient care by leveraging technology, innovation, and compassion. We also aim to educate and train the next generation of leaders in patient care and research. Our research and development team is working on advanced technologies, including molecular imaging, in-vitro diagnostics, image-guided therapeutics, and informatics to improve precision health. We strive to foster a culture of diversity, inclusion, transparency, and integrity. At Radiology, we are dedicated to recruiting team members who are enthusiastic about their work, adaptable, and enjoy achieving outcomes. We prioritize providing our staff with the necessary tools to perform their job effectively, assisting them in gaining new skills, and advancing within the organization. We believe in promoting a healthy work-life balance for our team and offer support to help achieve it. If you are interested in making a significant impact through clinical research with a global reach, we welcome you to apply! The Senior Clinical Research Coordinator (CRC2) will work closely with the Investigator and Clinical Research Manager (CRM) in a dynamic environment. The CRC2 will be responsible for supporting multiple staff members, including coordinators, and working on multiple studies. The main responsibilities include developing recruitment and retention strategies, overseeing study operation and conduct, ensuring regulatory compliance and financial logistics, and ensuring overall progress on projects. The CRC2 will report project progress to the CRM and troubleshoot any barriers. The successful candidate should have outstanding communication and organizational skills, the ability to proactively manage challenges, a strong background in clinical research, and attention to detail.
DESIRED QUALIFICATIONS:
- Investigator Initiated clinical trial experience.
- A Master's Degree in a relevant field is preferred.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, Scientific Review Committee, and Good Clinical Practices.
- Relevant work experience – i.e., in clinical research, device development, pharmaceutical industry etc.
- Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
- Demonstrated experience working independently and as part of a team.
LICENSES REQUIRED:
Must possess and maintain a valid California non-commercial Class C Driver’s License.
PHYSICAL REQUIREMENTS*:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
- Ability to drive day or night.
- - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs.
WORK STANDARDS:
- When conducting university business, must comply with California Vehicle Code and Stanford University driving requirements.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Core Duties:
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
- Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
Minimum Education and Experience Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills and Abilities:
- Strong interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
Certificates and Licenses Required Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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Drivers License Requirements
- Must possess and maintain a valid California non-commercial Class C Driver's License.
- Ability to drive day or night.
- When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.