Senior Clinical Research Coordinator

FTE: 50%

The Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition in the School of Medicine is seeking a Senior Clinical Research Coordinator (CRC2) to primarily help with data management for 2 national pediatric liver transplant registry studies. This individual may also conduct clinical research and work independently on complex projects/assignments in the area of Pediatric Hepatology and Liver Transplant. 

The selected candidate must have the ability to implement, organize and conduct all aspects of clinical studies combined with knowledge of good clinical practice (GCP) including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments). They will support patients participating in research studies and medical faculty in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research experience is required.  Previous clinical trial experience at Stanford and/or LPCH is desirable.

The Hepatology Section, within the Pediatric Gastroenterology Division has 7 pediatric transplant hepatologists with nationally recognized expertise through their research, teaching, and clinical programs. The Pediatric Liver Transplant program maintains the highest volume of pediatric liver transplants in the country with innovative destination programs (such as the combined heart liver transplant program). Stanford’s contribution to the two main national registry studies that the CRC2 will be helping to manage (SPLIT and Starzl Network) continues to advance research and innovative quality improvement initiatives that advance the care of all children in need of or who have received a liver transplant. The CRC2 hired for this position will also work closely with a dedicated staff of transplant nurse practitioners (APPs), nurses (RNs), office assistants (OAs) and medical assistants (MA) in coordinating care to consent patients in liver transplant clinic. 

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:

·         Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term registry studies and clinical trials.

·         Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.

·         Audit operations to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.

·         Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.

·         Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.

·         Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.

·         Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.

·         Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

• - 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:

• Relevant work experience in clinical research
• Excellent oral and written communication skills
• Experience with managing clinical data in a research setting
• Proficiency in using computers, software, and web-based applications in a previous administrative setting
• Proficiency in Spanish is preferred, but not required

EDUCATION & EXPERIENCE (REQUIRED):  Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills
• Proficiency with Microsoft Office and database applications.
• 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. May require a valid California Driver’s License.  Additional trainings and competencies obtained through continuing education, training coursework, webinars, etc. in any area of performing clinical research 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 disease and infections.

·         Primary clinic and study sites will be on the Palo Alto campus of Stanford (750 Welch Road and 770 Welch Road).

·         Position may require air flight travels to certain destinations (domestic and international, as needed) in order to participate in research-related events such as Investigator Meetings.

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 $34,550.00-$46,000.00 annually.