Clinical Research Coordinator
Job code: 4923
The Department of Urology is committed to excellence and improving everything we do. From our innovative patient care, to our highest caliber education program, and cutting-edge research, we work together to turn discoveries into reality and improve the lives of our patients. We are excited to announce an opportunity for a Clinical Research Coordinator 2 (CRC2) to join our department as an integral member of our research team. The CRC2 will oversee cooperative group oncology clinical trials, independently manage complex National Cancer Institute (NCI) clinical trials, and be the primary contact for industry sponsored trials and investigator-initiated project that will be undertaken by PIs in the Department of Urology. Experience working with oncology clinical research studies and a minimum of 2 years of experience in clinical research setting is preferred.
- 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
- Experience working with oncology clinical research studies.
- Minimum of 2 years of experience in clinical research setting.
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 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.
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.
- 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.
Add or subtract physical requirements based on the requirements of your specific job. (remove this statement for posting))