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Clinical Trials Associate

2 months ago

Stanford, California, United States Stanford University Full time

Position Overview:

The Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is looking for a dedicated full-time Clinical Research Coordinator Associate (CRCA) to oversee multicenter clinical trials focused on plasma and lung biomarkers, as well as innovative therapies for patients suffering from sepsis, pneumonia, and lung injury. This role involves working closely with patients in critical care settings, specifically at Stanford Hospital and Clinics.

Key Responsibilities:

  • Act as the primary liaison for research participants, sponsors, and regulatory bodies while managing studies from initiation to completion.
  • Evaluate participant eligibility and obtain informed consent in accordance with study protocols. Contribute to the development of recruitment strategies.
  • Oversee the collection and processing of study specimens.
  • Gather and manage patient and laboratory data for clinical research initiatives. Maintain research project databases, create flow sheets, and complete necessary study documentation.
  • Ensure adherence to research protocols and conduct thorough reviews and audits of case report forms for accuracy against source documents. Prepare submissions for regulatory compliance and manage Institutional Review Board renewals.
  • Assemble study kits for participant visits, coordinate the scheduling of procedures, and attend monitoring meetings with sponsors as the primary contact.
  • Monitor budget compliance and address any billing discrepancies in collaboration with finance and management teams.
  • Regularly interact with the principal investigator to ensure patient safety and proper study conduct.
  • Maintain essential documentation and accurate recording of patient and research data in compliance with institutional and regulatory standards.
  • Participate in monitoring visits and regulatory audits.

Desired Qualifications:

  • Interest in clinical study design and implementation, particularly in the context of critically ill patients.
  • Ability to manage research protocol activities in a dynamic, high-pressure environment.
  • Willingness to learn specimen handling and basic biospecimen processing techniques.
  • Strong interpersonal skills for effective communication with patients and healthcare professionals.
  • Familiarity with Institutional Review Board (IRB) policies and the informed consent process.
  • Timely communication with IRB regarding serious adverse events and protocol amendments.
  • Aptitude for reviewing medical records and maintaining accurate documentation.
  • Proficient in Microsoft Office applications.
  • Experience with all phases of clinical trials, particularly those funded by industry or NIH.
  • Knowledge of biospecimen management systems is a plus.
  • Fluency in Spanish is preferred.
  • Commitment to a minimum two-year tenure in this role.

Education & Experience Requirements:

  • A two-year college degree with two years of relevant experience, or a bachelor's degree in a related field, or an equivalent combination of education and experience.

Knowledge, Skills, and Abilities:

  • Excellent interpersonal skills.
  • Proficiency in Microsoft Office.
  • Understanding of medical terminology.

Certifications & Licenses:

  • Progressing towards certifications for basic patient measurements and tests, such as phlebotomy and EKG.

Physical Requirements:

  • Ability to frequently stand, walk, twist, bend, and use fine motor skills.
  • Occasional sitting, reaching, and performing desk-based tasks.
  • Ability to lift and carry objects weighing up to 40 pounds.

Working Conditions:

  • May involve exposure to hazardous materials and infectious agents.
  • Extended or unusual work hours may be required based on research needs.

Why Stanford is the Right Choice:

At Stanford University, we are committed to fostering a culture of growth, care, and discovery. Our employees enjoy:

  • Opportunities for professional development.
  • A supportive work environment.
  • Comprehensive health and wellness benefits.
  • Access to unique resources and programs.

Join us in making a meaningful impact in the field of clinical research.