Clinical Research Coordinator, Department of Medicine
The Department of Medicine, Division of Stanford Prevention Research Center (SPRC) is a consortium of renowned experts who are world leaders in investigating ways to prevent disease and promote health. Their work is focused on identifying the most practical, science-based solutions for addressing some of society's most pervasive and preventable health issues, such as obesity, diabetes, hypertension, and other chronic conditions and to raise the standards of scientific investigation that matters for health. SPRC investigators are collaborating on numerous, long-term projects designed to translate research into effective ways to promote well-being at every stage of life.
- 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.
* Other duties may also be assigned
- Above proficient understanding of scientific theory and methods.
- Proficiency with Oracle database applications.
- Demonstrated ability to work with older adults specifically in the area of women’s health.
- Previous experience training new staff on protocol adherence, outcome ascertainment, HIPAA compliance, retention strategies.
- Ability to work under deadlines with minimal guidance.
- Excellent organizational skills and demonstrated ability to complete detailed work accurately and in a timely fashion.
- Effective oral and written communication skills.
- Superior working knowledge of medical terminology and treatment including but not limited to cardiovascular disease, stroke protocol, cancer, fractures, dementia, PAD, DVT, and pulmonary embolism.
- Previous experience with electronic medical records and must have a working knowledge of the medical records structure for the large managed care providers in the United States (Kaiser, Sutter, Sharp, Dignity Health …).
- Previous experience with IRB submission and study scheduling.
- Database management skills.
- Experience with participant retention strategy development.
- Previous experience with the coordination of a medical outcome study.
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.
- 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.
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/.
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Grade: H
- Requisition ID: 84405