The Department of Ophthalmology at the Stanford University School of Medicine is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of multiple clinical trials and research studies. This is an exciting opportunity to join a department with rapidly-expanding research efforts and to support multidisciplinary, translational research with direct impact on patient care. This individual will be involved with all aspects of observational human subjects research from project planning, to subject recruitment and consent, to data analysis and dissemination. This individual will work under close direction of the principal investigator and/or senior study coordinator. Please visit the Department of Ophthalmology’s research website for information on some of the cutting-edge research our faculty are performing: http://med.stanford.edu/ophthalmology/research.html

Duties include:

• Serve as primary contact with research participants.
• Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.
• Assist in developing recruitment strategies.
• 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.
• 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.
• 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.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Prepare data summaries, assist with data analysis, abstract and manuscript preparation.

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• Knowledge of the principles of clinical research and federal regulations.
• Familiarity with IRB guidelines and regulations.
• Previous experience with clinical trials.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

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 is 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.

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.

Additional Information

Schedule: Full-time
Job Code: 4924
Employee Status: Regular
Grade: F
Department URL: http://ophthalmology.stanford.edu/
Requisition ID: 87826