Stanford University, Department of Anesthesia, Pain & Perioperative Medicine is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under direction of the Clinical Research Manager and/or principal investigator. See Department of Anesthesia website at http://med.stanford.edu/anesthesia.html.

Core Duties Include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out:
• Coordinate initiation of research studies, working collaboratively with the study sponsor, IRB, RMG and OSR at Stanford.
• Develop and implement enrollment strategies to ensure adequate and timely enrollment of participants; identify and changes to recruitment strategies when necessary.
• May direct the work of others; oversee work of medical students, or temporary employees.
• Identify specific areas requiring training and coordination at LPCH that include, but may not be limited to medical staff, clinical nursing units, lab, pharmacy, and radiology.
• Develop training tools designed to address the specifics of each research study as it relates to the different clinical departments. 
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies: Identify qualified potential participants, obtain informed consent, screen and enroll research participants in multiple consecutive studies.
• Prepare the Informed Consent document, IRB application, required regulatory documents, study tools, and attend informational study conferences. 
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms:
• Participate in grant applications, writing IRB protocols;
• Preparation of bibliographies and on line literature research.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
• Prepare regulatory submissions, and ensure institutional Review Board renewals are completed:
• Ability to independently understand, interpret, and communicate complex policies and procedures; ensure compliance with policies.
• Using knowledge of GCPs and the ancillary services at Stanford, ensure all aspects of study involvement comply with relevant regulations.
• Regularly inspect study documents to ensure ongoing regulatory compliance; identify and implement changes when necessary.
• Work with IRB to submit/update protocols; independently write and/or coordinate protocol renewals with PI.
• Participate in grant applications, writing IRB protocols;
• Preparation of bibliographies and on line literature search.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff:
• Assist in early study negotiations with sponsors of industry-sponsored research.
• Assist in preparing accurate study budgets.
• Regularly manage expenditures, including ensuring milestones met are properly invoiced.
• Work closely with PI, Clinical Research Manager, or Finance staff to monitor expenditures, gather information to resolve any issues related to budget/billing issues. 
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct:
• Monitor participants for any adverse events related to participant health status and immediately reports to PI. Monitor participants for any adverse events related to participant health status and immediately reports to PI.
• Meets with PI to report progress on studies, initiates communications with PI regarding study milestones, requests from agency, or patient communications/concerns. 
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

*Other duties may also be assigned

Desired Qualifications:

• Bachelor’s degree strongly preferred.
• Demonstrated experience in writing skills and understanding of research grant application process.
• Comprehensive understanding of scientific principles.
• Ability to work under deadlines with general guidance is essential.
• Ability to learn and master computer programs databases, and scientific applications.
• Strong analytical skills and excellent judgment.
• Ability to work under deadlines with general guidance is essential
• Excellent organization skills and demonstrated ability to accurately complete detailed work.

Education & Experience (Required):

• Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

Knowledge, Skills and Abilities (Required):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

Certifications & Licenses:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred.

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:

• Occasional evening and weekend hours based on research requirements and business needs.
• May require work with, or in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.

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.

Stanford University, located between San Francisco and San Jose in the heart of California’s Silicon Valley is one of the world’s leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world. Supporting that mission is a staff of more than 10,000, which is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting of professionals looking to advance their careers. Excellent learning opportunity and experience for the future career in medicine and healthcare profession.

Clinical Research Coordinator Associate    
Job Code: 4924   
Grade: F