Clinical Research Coordinator Associate- HYBRID

Stanford University
  • Stanford, CA
    3 days ago

    Job Description

    Stanford Radiology is committed to providing exceptional patient care by leveraging technology, innovation, and compassion. We also aim to educate and train the next generation of leaders in patient care and research. Our research and development team is working on advanced technologies, including molecular imaging, in vitro diagnostics, image-guided therapeutics, and informatics to improve precision health. We strive to foster a culture of diversity, inclusion, transparency, and integrity.

    We are currently looking for a Clinical Research Coordinator Associate (CRCA) to assist with the coordination of clinical research studies. As a Clinical Research Coordinator Associate, you will coordinate various aspects of clinical studies, including participant recruitment and consent, study visits and procedures, regulatory activities, data collection and management, and study documentation. You will work under the direction of the principal investigator and/or clinical research supervisor and may independently coordinate assigned study activities within established protocols and procedures.

    At Radiology, we are dedicated to recruiting team members who are enthusiastic about their work, adaptable, collaborative, and enjoy achieving outcomes. We prioritize providing our staff with the tools and support necessary to perform their jobs effectively, develop new skills, and advance within the organization. We also value a healthy work-life balance. If you are interested in making a significant impact through innovative clinical research with a global reach, we welcome you to apply.

    DESIRED QUALIFICATIONS:

    • 1-2 years of experience in clinical research or a comparable research role.
    • Strong organizational, communication, and interpersonal skills, with a demonstrated ability to manage multiple priorities and work effectively within a multidisciplinary team.
    • Familiarity with Good Clinical Practice (GCP), HIPAA, and applicable clinical research regulations.

    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.

    [REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE. REMOVE IF NOT APPLICABLE]

    Drivers License Requirements

    • Must possess and maintain a valid California non-commercial Class C Driver''s License.

    • Ability to drive day or night.

    • When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

    Core Duties:

    • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
    • Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
    • 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.
    • 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.

    Minimum Education and Experience

    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:

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

    Certificates and Licenses Required

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

    Core Duties:

    • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
    • Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
    • 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.
    • 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.

    Minimum Education and Experience

    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:

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

    Certificates and Licenses Required

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

    Numbers & Facts

    LocationStanford, CA

    Skills

    • Billingunmatched
    • Budgetingunmatched
    • Case Report Form (CRF)unmatched
    • Class C Licenseunmatched
    • Clinical Dataunmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Data Collectionunmatched
    • Data Managementunmatched
    • Database Administrationunmatched
    • Database Programmingunmatched
    • Disability Accommodationsunmatched
    • Diversityunmatched
    • Documentationunmatched
    • Driver's Licenseunmatched
    • Establish Prioritiesunmatched
    • Expense Trackingunmatched
    • Financeunmatched
    • GCP (Good Clinical Practices)unmatched
    • HIPAA (Health Insurance Portability and Accountability Act)unmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • Informaticsunmatched
    • Interpersonal Skillsunmatched
    • Laboratory Managementunmatched
    • Legalunmatched
    • Lift/Move 40 Poundsunmatched
    • Maintain Complianceunmatched
    • Material Movingunmatched
    • Medical Terminologyunmatched
    • Microsoft Officeunmatched
    • Molecular Analysisunmatched
    • Monitor Regulationsunmatched
    • Multitaskingunmatched
    • Organizational Skillsunmatched
    • Patient Careunmatched
    • Patient Safetyunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Project/Program Managementunmatched
    • Radiologyunmatched
    • Recruiting Strategyunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Research & Development (R&D)unmatched
    • Sample/Specimen Processingunmatched
    • Society of Clinical Research Associates (SoCRA)unmatched
    • Specimen Collectionunmatched
    • Staff Policiesunmatched
    • Startupunmatched
    • Strategic Planningunmatched
    • Team Playerunmatched
    • Training/Teachingunmatched
    • University/School Policiesunmatched

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