Job Details

Stanford University

Clinical Rsch Coordinator
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Position Number: 734152
Location: Stanford, CA
Position Type: Laboratory and Research

Stanford University

Clinical Rsch Coordinator

Job Number: 69513

The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) in the Pediatric Division of Stem Cell Transplantation and Regenerative Medicine, Stanford University School of Medicine, seeks a Clinical Research Coordinator 2 to conduct clinical research and independently manage significant and key aspects of a large study or all aspects of one or more small translational research studies in stem cells, cells, and gene therapy. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
The mission of the SCGT-CTO is to translate basic discoveries into innovative therapeutics to treat children with debilitating diseases for which there are no cures at present and the identification of curative therapies for such children will offer them new hope for health, improvement in their quality of life, and a reduction in medical costs compared to their present palliative, but not curative therapies.
The Clinical Research Coordinator is responsible for the overall management and implementation of clinical research protocols, assuring compliance, efficiency, and the safety and well-being of trial participants.

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.

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.

* - Other duties may also be assigned

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:

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.

* - 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:

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.

Job: Research

Location: School of Medicine
Schedule: Full-time
Classification Level: H

To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.