Clinical Research Coordinator III

Stanford University is seeking a Lead Clinical Research Coordinator to lead clinical research projects and contribute to 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. May include the supervision of clinical research staff.

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:

• May be exposed to blood borne pathogens.
• May be required to work non-standard, extended or weekend hours in support of research or project work.

WORK STANDARDS:

• 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. Determineeffective strategies for promoting/recruiting research participants andretaining participants in long-term clinical trials.

• Monitor and oversee data management for research projects.Develop and manage systems to organize, collect, report, and monitordata collection. Extract, analyze, and interpret data.

• Develop project schedules, targets, measurements, andaccountabilities, as assigned. Lead team meetings and prepare/approveminutes.

• Supervision of staff or students, as assigned, including hiring,performance management and coaching; mentoring and training of staff andassistance with preparation of performance evaluations for staff who donot directly report to this role, and performing related duties, inaddition to instruction on project work.

• Audit operations, including performing internal monitoring, toensure compliance with applicable regulations; provide leadership inidentifying and implementing corrective actions/processes. MonitorInstitutional Review Board submissions and respond to requests andquestions. May have specialization such as leading training for thegroup, leading quality program for the group or other specialized andmore complex responsibilities.

• Collaborate with principal investigators and study sponsors,monitor and report serious adverse events, and resolve study queries.Analyze completed study results to aid PI in the development ofrecommendations to enhance quality outcomes.

• Provide leadership in determining, recommending, and implementingimprovements to policies/processes; define best practices.

• Develop study budget with staff and principal investigator,identifying standard of care versus study procedures. Track patient andstudy specific milestones, and invoice sponsors according to studycontract. Develop and manage the financial timeline and personnelresources; may oversee post-award deliverable.

• Ensure regulatory compliance. Regularly inspect study documentsto ensure ongoing regulatory compliance.

• Work with principal investigator to ensure Investigational NewDrug applications are submitted to the FDA when applicable. EnsureInstitutional Review Board renewals are completed.

Minimum Education:

Bachelor's degree in a related field

Minimum Experience:

Four years of experience in clinical research, or an equivalentcombination of education and relevant experience.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Proficiency in Microsoft Office and databaseapplications.

• Experience with research protocols and regulatory or governingbodies, which include HIPAA and FDA regulations, Institutional ReviewBoard requirements, and Good Clinical Practices.

• Knowledge of medical terminology.

• Demonstrated project/program leadership skills.

• Demonstrated disease knowledge / study design experience ofstudies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of ClinicalResearch Professionals certification is preferred.