Clinical Research Coordinator Associate (2 Vacancies) (On-Site)

Responsibilities

• Prepare 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.
• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Care for 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.
• 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.

Stanford University Provides Reasonable Accommodation

• 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.

Stanford University is an Equal Opportunity 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.