Research Study Associate

2 weeks ago

Stanford, California, United States Stanford University Full time

Position Overview:

The Department of Medicine, specifically within the Division of Pulmonary, Allergy and Critical Care Medicine, is looking for a dedicated full-time Clinical Research Coordinator Associate (CRCA). This role involves overseeing multicenter clinical trials focused on plasma and lung biomarkers, as well as innovative therapies for patients experiencing sepsis, pneumonia, and lung injuries. The studies are primarily conducted at Stanford Hospital and Clinics, frequently involving patients in critical care settings.

Key Responsibilities:

  • Act as the main liaison for research participants, sponsors, and regulatory bodies, managing studies from initiation to completion.
  • Assess participant eligibility and obtain informed consent in accordance with established protocols, while also contributing to recruitment strategy development.
  • Coordinate the collection and processing of study specimens.
  • Gather and manage patient and laboratory data for various clinical research initiatives, maintaining research project databases and preparing necessary documentation.
  • Ensure adherence to research protocols, conducting reviews and audits of case report forms for accuracy against source documents. Prepare regulatory submissions and manage Institutional Review Board renewals.
  • Prepare study kits for participant visits, oversee scheduling of procedures, and coordinate documentation while participating in sponsor monitoring meetings.
  • Monitor financial expenditures related to studies, ensuring compliance with budgets and resolving billing discrepancies in collaboration with finance personnel.
  • Maintain regular communication with the principal investigator to ensure patient safety and compliance with study protocols.
  • Ensure proper documentation and record-keeping of patient and research data according to 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 activities in a dynamic, high-pressure environment such as the intensive care unit.
  • Willingness to learn specimen handling and basic biospecimen processing techniques.
  • Strong interpersonal skills for effective communication with patients and healthcare providers.
  • Familiarity with Institutional Review Board (IRB) policies and the informed consent process.
  • Proficient in timely communication with IRB regarding serious adverse events and protocol amendments.
  • Aptitude for reviewing medical records and maintaining accurate documentation.
  • Good computer skills, particularly in Microsoft Word and Excel.
  • Experience in various phases of clinical trials, including industry-sponsored and NIH-funded studies.
  • Familiarity with data management systems such as REDCap and EPIC.
  • Fluency in Spanish is preferred.
  • Preference for candidates who can commit to a minimum of two years 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:

  • Strong interpersonal and communication skills.
  • Proficiency in Microsoft Office applications.
  • Understanding of medical terminology.

Certifications & Licenses:

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

Physical Requirements:

  • Frequent standing, walking, bending, and fine motor skills are required.
  • Occasional sitting, reaching, and desk-based tasks, with the ability to lift and carry objects up to 40 pounds.

Working Conditions:

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

Why Stanford?

At Stanford University, we are committed to fostering a diverse and inclusive environment. Our team is dedicated to making a meaningful impact in the field of medicine and research. We offer a comprehensive benefits package, including career development opportunities, health care benefits, and a supportive work culture.

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