The Clinical Research Coordinator Associate is responsible for the overall implementation of an assigned set of research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and Clinics.  The CRCA will work as part of a clinical trials research team and report to the Clinical Research Manager and various Principal Investigators conducting clinical research within the Stanford Stroke Center.  Responsibilities include 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 with HIPAA regulations. He/she participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies.  The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including neuropsychological testing, collection and processing of blood samples.  Maintain drug accountability, adequate study supplies and equipment. The coordinator will 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.

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 and shipping.
• 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, prepare study documents for data collection.
• Attend monitoring meetings with sponsors as needed, acting as primary contact.
• 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:

1+ years of Clinical Research Coordinator experience.

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):   CERTIFICATIONS & LICENSES:

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

PHYSICAL REQUIREMENTS*:  

* - 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:  

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.
• 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.
• 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: 4921
• Employee Status: Regular
• Grade: I
• Department URL: http://genetics.stanford.edu/
• Requisition ID: 85834