"Clinical Research Coordinator Associate"

The Division of Nephrology in the Department of Pediatrics at Stanford University 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 close direction of the principal investigators and/or program manager/study coordinators/supervisor. Opportunity for flexible work schedule (hybrid/telecommuting + onsite) may be arranged for this position, as needed.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• 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.
• 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.
• Participate in monitor visits and regulatory audits.

Other duties may also be assigned

Desired Qualifications:

• Stanford IRB Knowledge
• Assistant Clinical Research Coordinator experience
• CITI Training

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:

• 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 disease and infections.

May require extended or unusual work hours based on research requirements and business needs.