Clinical Research Coordinator 2 (Gastro Studies)

The Division of Gastroenterology and Hepatology has a long tradition of major contributions in basic research, a new commitment to clinical and outcomes research, a track record of training fellows for academic careers, and a longitudinal commitment to providing care for patients with complex gastrointestinal and liver diseases.

The Kwo Lab is seeking a Clinical Research Coordinator II (CRC2) to provide support for clinical research efforts in the Division of Gastroenterology and Hepatology.

In this role, the CRC2 will independently conduct 4-6 new gastroenterology complex clinical drug studies to test novel therapies in chronic liver disease, including the MERCK IBD Study.

Responsibilities will also include overseeing investigator-initiated studies. These studies will focus on testing novel therapies in human subjects to treat viral liver disease, metabolic dysfunction associated with steatotic liver disease, alcohol-associated liver disease, and cirrhosis, and will include Phase 1, Phase 2, and Phase 3 studies.

The CRC2 will independently manage the studies from start-up through close-out and conduct FDA audits if applicable.

Duties include :

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting / recruiting research participants and retaining participants in long-term 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.

• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare / approve minutes.
• Formally supervise, train, and / or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, 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.

DESIRED QUALIFICATIONS :

Strong organizational skills.

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 in 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 :

Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License.

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.

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.

WORKING STANDARDS :

• Interpersonal Skills : Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety : Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns;

uses and promotes safe behaviors based on training and lessons learned.

Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide.

The expected pay range for this position is $69,100 to $92,000 per annum.

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.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package.

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