Clinical Research Coordinator 2

Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) to join their expanding clinical research program in the Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM). This is an opportunity to work in an intellectually stimulating and collaborative research environment focused on the care of patients with lung diseases from a variety of causes. The CRC2 will work independently on progressively complex projects/assignments and will independently manage key aspects of multiple research studies, including industry-sponsored, NIH and PI-initiated clinical trials as well as blood and tissue banking registries. This CRC2 position will also be involved in the training and oversight of CRCAs and ACRCs in accordance with changes in study workloads and the growing research needs of the division. This position will work under the general direction of PACCM principal investigators and the Clinical Research Manager.

Excellent computer skills are required including MS Word and Excel. The candidate must also demonstrate outstanding written and verbal communication skills and the ability to take initiative and work as a team player or independently. They must be detail- oriented and have strong problem-solving and organizational skills; must be flexible and cooperative to field and appropriately prioritize requests from supervisor, faculty, and staff, and demonstrate the ability to follow through with projects and manage deadlines well. The candidate should have outstanding interpersonal and verbal skills required for interacting with personnel from multiple departments, communicating with sponsors, and with patients (e.g., including while obtaining informed consent).

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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.

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.

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.