Cancer Clinical Research Coordinator 2 - Hematology
- Employer
- Stanford University
- Location
- School of Medicine, Stanford, California, United States
View more
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
- Oversee and manage all aspects of clinical trials including industry and investigator initiated trials.,including subsites , if applicable
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Manage data/oversee data management for research projects. Meet DSMC requirements for site management up to date. Develop and manage systems to organize, collect, report, and monitor data collection. Extract and analyze data.
- Maintain site regulatory file,per CCTO guidelines.
- Develop project schedules, keep targets, measurements, and accountabilities, as assigned. Occasionally lead team meetings and prepare/approve minutes.
- Formally mentor new staff or students, as assigned, participate in hiring process, prepare or assist 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/SRC/DSMC submissions, and respond to requests and questions.
- Collaborate with principal investigators, 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, Track patient and study specific milestones, review patient billing and invoice sponsors according to study contract.
- Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Manage audit preparation of clinical trials at Stanford and subsites. Provide oversight to subsites.
- Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
- Strong interpersonal skills
- Proficiency with 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.
- 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.
- 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 disease 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 bases 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
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 87202
Organization
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At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment.
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Student Enrollment
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Campus
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- 5:1 student to faculty ratio
Stanford University is an Equal Employment Opportunity and Affirmative Action Employer and is committed to recruiting and hiring qualified women, minorities, protected veterans and persons with disabilities.
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