Clinical Research Coordinator Associate

The Clinical Research Coordinator Associate is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and Clinics. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research.

Responsibilities include:

• Preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations.
• Advise the IRB of amendment changes to the protocol and complete annual protocol renewals.
• Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines.
• Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations.
• Participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies.
• Interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment.
• Maintain drug accountability, adequate study supplies and equipment.
• Oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject’s medical record.
• Report all serious adverse events promptly to investigators, sponsors and the IRB.
• Protect the rights, safety and well-being of human subjects involved in the clinical trials.

Qualifications:

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

Working Conditions:

• Occasional evening and weekend hours.

EEO Statement: Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.