Clinical Research Coordinator, Stanford ChEM-H
- Assist investigators in the design of molecular hypothesis-driven studies involving human subjects, including reviewing the literature for analogous study designs, clinical protocol formulation, drafting table of events, drafting, submitting, revising, and renewing IRB applications, and registration on ClinicalTrials.Gov.
- Oversee subject screening and recruitment to meet study enrollment goals. Determine effective strategies for identifying and 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.
- Supervise, train and/or mentor students or postdoctoral fellows associated with the project in the design and execution of studies involving human subjects. Advise faculty and staff involved in the study on all aspects of the study, including competencies required by themselves and their trainees in order to initiate and successfully complete the study.
- Develop study budget with principal investigators, identifying standard of care versus study procedures. Track all invoices associated with clinical study. Provide principal investigators guidance on how to keep the overall study within budget.
- 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.
- 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.
Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
- 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.
- Experience with electronic patient record systems required to pre-screen human subjects for eligibility to participate in individual studies (e.g. EPIC)
- Experience with relevant electronic systems to support clinical studies (e.g. eProtocol, RedCap)
- Familiarity with best practices for working with clinical professionals in order to identify and consent eligible human subjects in individual studies
- Advanced degree in a relevant field, such as chemistry, biology, biochemistry, or engineering.
- Research mentoring experience.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification.
- Valid California Driver's License.
- 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 the job.
- 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.
- 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, http://adminguide.stanford.edu.