Clinical Research Coordinator 2- BMT

JOB PURPOSE:

Conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

CORE DUTIES:

• 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.

MINIMUM REQUIREMENTS:

Education & Experience:

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:

• 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.

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.
• Ability to drive day or night, if applicable.
• • 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.
• Full timeor part time:
• Number of hours per week: 40
• Shift timing/schedule: Day
• Number of temps required :1
• Will the resource be working with minors? NO
• How many years of experience are required? 2+
• Will this role extend or possibly convert to a FTE? yes
• Top 3 requirements to hire? Oncology treatment trials, Phase I, EPIC and onsite at a health institution (not looking for CRO or Pharma CRA experience)
• Location Address: 780 or 800 Welch Road, Palo Alto
• Remote/onsite/hybrid: Hybrid

This is the pay range that RightSourcing (a part of Magnit) reasonably expects to pay someone for this position, however, as a supplier your expected pay range may vary and/or include certain benefits like: Medical, Dental, Vision, 401K.