Clinical Research 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 in search of a dedicated full-time Clinical Research Coordinator Associate (CRCA). This role is essential for managing multicenter clinical trials that focus on plasma and lung biomarkers, as well as innovative treatments for patients suffering from sepsis, pneumonia, and lung injuries. The CRCA will be integral to a passionate clinical trials research team and will report directly to the Clinical Research Manager along with various Principal Investigators engaged in clinical research.

Key Responsibilities:

  • Act as the primary liaison for research participants, sponsors, and regulatory bodies, overseeing studies from initiation to completion.
  • Assess participant eligibility and obtain informed consent in accordance with study protocols. Assist in the formulation of recruitment strategies.
  • Coordinate the collection and processing of study specimens.
  • Manage patient and laboratory data for clinical research initiatives, maintaining research project databases and preparing necessary documentation.
  • Ensure strict adherence to research protocols, conducting reviews and audits of case report forms for accuracy and completeness. Prepare submissions for regulatory bodies and ensure timely Institutional Review Board renewals.
  • Assemble study kits for participant visits, oversee scheduling of procedures, and participate in monitoring meetings with sponsors.
  • Monitor project expenditures and ensure compliance with study budgets, addressing any billing discrepancies in collaboration with financial staff.
  • Engage regularly with the principal investigator to uphold patient safety and maintain compliance with study protocols.
  • Ensure proper documentation and recording of patient and research data in accordance 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 providers.
  • Familiarity with Institutional Review Board policies and the informed consent process.
  • Proficient in timely communication regarding Serious Adverse Events and protocol amendments.
  • Aptitude for reviewing medical records and maintaining accurate documentation.
  • Proficient computer skills, particularly in Microsoft Office applications.
  • Experience with clinical trials, particularly those funded by industry or NIH.
  • Familiarity with data management systems such as REDCap, EPIC, and OpenSpecimen is advantageous.
  • Fluency in Spanish is preferred.
  • Commitment to a minimum two-year tenure in this position.

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 skills and 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 perform fine motor tasks.
  • Occasional requirements to sit, reach, perform desk-based tasks, and lift objects up to 40 pounds.
  • Rarely kneel, crawl, or climb, with minimal lifting of heavier objects.

Working Conditions:

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

Working Standards:

  • Demonstrates effective collaboration with colleagues and external organizations.
  • Commits to safety and promotes safe practices based on training.
  • Expected to comply with all applicable university policies and procedures.

Compensation:

The anticipated pay range for this role is between $31.73 and $36.54 per hour, contingent upon various factors including the responsibilities of the position and the qualifications of the selected candidate.

Why Join Stanford?

At Stanford University, we are committed to fostering a diverse and inclusive environment. We offer numerous benefits, including career development opportunities, generous time-off policies, and comprehensive health care plans. Our culture encourages personal and professional growth, ensuring you have the resources to thrive.

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