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    Clinical Research Coordinator/Specialist - Stanford, CA, United States - Stanford University

    Stanford University
    Stanford University Stanford, CA, United States

    3 weeks ago

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    Description
    This is an exciting opportunity to join the Neuroscience Clinical Trials Team in Neurology & Neurosurgery.

    This team runs clinical trials for a wide range of disease areas including:
    Epilepsy, Neuorimmunology/Multiple Sclerosis, Alzheimers, Autonomic Disorders, Device Neurosurgery, Stem Cell Neurosurgery, Headache, Radiology, Parkinson's and more

    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; 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.

    Protect the rights, safety and well-being of human subjects involved in the clinical trials.

    Serve as primary contact with research participants, sponsors, and regulatory agencies. 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.
    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.
    * - 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.

    Proficiency with Microsoft Office.
    Knowledge of medical terminology.

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

    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.
    Occasional evening and weekend hours.
    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, .

    54 per hour.

    The Cardinal at Work website () provides detailed information on Stanford's extensive range of benefits and rewards offered to employees.



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