Clinical Research Coordinator 2

About the job

The Emmanuel Mignot Lab at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

DESIRED QUALIFICATIONS:

• 3+ years of experience working in Sleep Medicine clinical trials.
• Experience with clinical trial study start-up and close-out activities.
• Previous experience serving as a study lead for a clinical trial that underwent an FDA audit.
• Direct participation and experience supporting an FDA audit.
• Strong knowledge and experience maintaining Investigator Site Files (ISF) and ensuring proper documentation and organization.
• Strong understanding of clinical trial documentation, regulatory requirements, and study compliance.
• Knowledge of sleep medicine disorders
• Experience participating in FDA audits
• Experience training and supervising a group of at least four Clinical Research Assistants (CRCAs)
• Experience participating in study start-up and closeout activities
• Experience recruiting and retaining complex patient populations in clinical trials
• Experience using Electronic Data Capture (EDC) systems and vendor portals
• Experience performing ECGs

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.

- 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.

### Responsibilities

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.

Qualifications**

[REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE. REMOVE IF NOT APPLICABLE]

****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.

Additional Information

-** Job Identification: 201588 - Job Category: Research - Posting Date: 2026-11-03 - Locations: 450 Jane Stanford Way, Stanford, CA, 94305, US (Hybrid) - Pay Range: $75,996-$141,859 - Pay Frequency: Annually - Fixed Term: N - Stanford Schools and Units: School of Medicine - Full time or Part time: **Full Time