Job Description

The Division of Pediatric Critical Care Medicine is seeking a Temporary Clinical Research Coordinator Associate (CRCA) to support clinical and translational research aimed at advancing therapies for critically ill and injured pediatric patients. The CRCA will work closely with principal investigators to coordinate moderately to progressively complex aspects of research studies—ranging from managing key components of large studies to independently overseeing smaller projects. This work plays a vital role in translating discoveries from bench to bedside, with the potential to improve outcomes for future pediatric patients.

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

The division has a growing team, including long-tenured faculty, staff, and leadership. The division's activities reach all parts of the mission: patient care, education, and research. The CRCA will have a great deal of exposure to all of these areas and will be communicating with a broad range of individuals, both internally and externally. Supporting the division is a strong operations team of about 30 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.

Additionally, this role is part of the Department of Pediatrics, the second-largest department in the Stanford School of Medicine. The Department offers robust training programs, professional development opportunities, and a vibrant community where staff are supported and valued.

We invite you to learn more about our work and team culture by exploring our website:

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

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.

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $36 - $40/ hour.

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