Clinical Research Coordinator Associate

The Childhood Research Obesity Prevention Lab under the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition (Pediatric GI) within Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies.  Coordinate moderately complex aspects of one or more clinical studies.  Work under close direction of the principal investigator and/or study coordinator/supervisor.

The Pediatric GI Division has approximately 40 pediatric gastroenterologists with nationally recognized expertise through their research, teaching, and clinical programs which attracts leading candidates to their fellowship program.  We have a mission of healing children with digestive disease through innovation.  Our Pediatric GI Specialty provides comprehensive GI care to children throughout our region. We lead global destination programs that deliver highly specialized care and train the next generation of pediatric gastroenterologists, and inspire hope through innovation.  Our high quality, collaborative care is driven by cutting-edge research and active partnerships between doctors, nurses, and staff throughout the Stanford Medicine Children’s Health network, scientists at Stanford University, and patientfamilies.  Together, we are changing the lives of children today and shaping care for tomorrow.

The Department of Pediatrics is a dynamic, stimulating place to work and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

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.

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 $27.88 to $36.54 hourly.

DESIRED QUALIFICATIONS:

• Excellent oral and written communication skills
• Experience in conducting study participant screening
• Experience with maintaining clinical data in a research setting
• Proficiency in using computers, software, and web-based applications in a previous administrative setting

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.

Additional PHYSICAL REQUIREMENTS: (remove if none)

WORKING CONDITIONS:

Occasional evening and weekend hours.