Stanford’s Division of Reproductive Endocrinology and Infertility (REI) within the Department of Obstetrics & Gynecology is seeking an experienced Clinical Research Coordinator 2 to lead the REI clinical research operations and work independently on progressively more complex projects/assignments. The successful Clinical Research Coordinator 2 candidate will independently manage significant and key aspects of multiple NIH and industry funded infertility research studies and oversee the work of junior research staff.

Duties include:

• 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 document 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.

* - Other duties may also be assigned

EDUCATION & EXPERIENCE (REQUIRED):

• 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 (REQUIRED):

• Strong interpersonal skills
• Proficiency with 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.

CERTIFICATIONS & LICENSES:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California 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.

* - 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.

Additional Information

Schedule: Full-time
Job Code: 4923
Employee Status: Regular
Grade: H
Requisition ID: 84968