"Clinical Research Coordinator Associate (CRCA)"

The Department of Pediatrics, Division of Neonatal and Developmental Medicine aims to provide optimum state-of-the-art care for critically ill and recovering neonates and infants. We are dedicated to the School of Medicine's mission of advancing and exploring innovative and novel biomedical, translational, and clinical research and education through the nurturing stimulation of interactions among basic and clinical scientists, clinicians, and educators throughout the School of Medicine and University, as well as with the private and public sectors. Through our integrated research, education, patient, and community outreach programs, we are committed to maintaining the highest standards of academic medicine and patient care.

The Division is seeking a 1.0 FTE Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies in the LPCH Neonatal Intensive Care Unit. He/she will work as part of a clinical trials research team and report to the Clinical Research Manager and to various Principal Investigators conducting clinical research. The CRCA will support federal and non-federal clinical research studies. Responsibilities include preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advise the IRB of amendment changes to the protocol and complete annual protocol renewals. Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations. He/she participates in data retrieval, reporting and preparation of files and Case Report Forms for the various studies. The successful candidate will interact with subjects by scheduling follow-up evaluation visits, and study related assessments. The coordinator will report all serious adverse events promptly to investigators, sponsors and the IRB and will protect the rights, safety and well-being of human subjects involved in the clinical trials.

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.
• 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 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

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

DESIRED QUALIFICATIONS:

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.
• 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:

Occasional evening and weekend hours.

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 hourly pay range for this position working in the California Bay area is between $31.84/hr. to $37.79/hr. based on commensurate experience and background.