Clinical Research Coordinator 2

7 days ago

Stanford CA, United States Stanford University Full time

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 conduct clinical research and work independently on increasingly complex projects and assignments. The CRC2 will be primarily responsible for managing several hepatology research projects, specifically focusing on a new research project startup called the Tracer Study. Responsibilities include completing feasibility forms, assessing patient populations using the STARR database, and documenting laboratory, radiological, and other clinical testing platforms. Additionally, the role involves independently managing significant aspects of a large study or all aspects of one or more small research studies.
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. 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 determining, recommending, and implementing improvements to policies/processes; 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. Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Proficiency in Microsoft Office and database applications.
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations,
Knowledge of medical terminology.

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 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.

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.

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 Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Supporting this mission is our diverse and dedicated 17,000 staff. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
We provide superb retirement plans, generous time-off, and family care resources.
Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at stanfordelr@stanford.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

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