Clinical Research Coordinator — Trials & Compliance Lead

Stanford University; Palo Alto (CA); Vor Ort; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Stanford University is seeking a Clinical Research Coordinator Associate to oversee the management and implementation of multiple research protocols at Stanford Hospital and Clinics. You will ensure regulatory compliance, assist with IRB submissions, consent processes, data collection, and CRF preparation, working with Principal Investigators.

Responsibilities include recruitment, subject scheduling and follow-up, adverse event reporting, drug accountability, and maintaining study supplies,

Qualifikationen

• Preparation of initial study documents for IRB submission in compliance with local, state and federal regulations.
• 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.

Aufgaben

• 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.
• Collect, record and maintain data files and Case Report Forms for the various studies.
• Schedule diagnostic and research evaluation visits and 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 and report adverse events to physicians for documentation.
• 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.

Kenntnisse

Interpersonal Skills

Jobbeschreibung

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. 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 collection of blood samples, processing and shipment. 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.

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.