Clinical Research Coordinator Associate - Now Hiring

Stanford Medicine Santa Clara, CA
clinical research research coordinator research clinical research regulatory team education coordinate protocols data case report forms report
November 30, 2022
Stanford Medicine
Santa Clara, CA
FULL_TIME, PART_TIME

The Divisions of Pediatric Critical Care Medicine is seeking a Clinical Research Associate to conduct clinical research on progressively more complex projects and assignments. Independently manage significant and key aspects of large studies or all aspects of one or more small research studies.

This is an onsite role requiring you to be on campus in Palo Alto, CA.

We are a growing team including long-tenured faculty, staff, and leadership. The Division activities reach all parts of the mission: patient care, education, and research. The Clinical Research Associate will have a great deal of exposure to all these areas and will be communicating with a broad range of individuals at the Executive level, internally and externally. Within the Divisions and Center, there is a strong operations team of about 15 people. We are a supportive group that prioritizes well-being, with many team events and opportunities for professional development and personal growth. We value balancing home and work life. We foster an environment that leads to fulfilling and rewarding careers at Stanford University for all staff. Please check out our website and social media channels below and come see about working for an organization that directly impacts the lives of children.

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
  • Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
  • Coordinate collection of study specimens and processing-- some protocols may require the CRC to collect and process the research samples.
  • 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 the 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.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Spanish speaking

EDUCATION & EXPERIENCE (REQUIRED):

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 (REQUIRED):

  • Strong interpersonal skills
  • Proficiency with Microsoft Office
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
  • Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

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

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:

  • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
  • May require extended or unusual work hours based on research requirements and business needs.

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