Clinical Research Coordinator

• Job Title: Clinical Research Coordinator 2- BMT


• Duration: 6+ months temporary position with possible extension or FTE

• Location : Stanford, CA (HYBRID)

• Schedule : 8am-5pm (3 days on campus) 40hrs per week





Job Purpose

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

Core Duties & Responsibilities


- Oversee subject recruitment and study enrollment goals. Develop effective strategies for 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. Extract, analyze, and interpret research data.
- Develop project schedules, targets, measurements, and accountabilities as assigned. Lead team meetings and prepare or approve meeting minutes.
- Formally supervise, train, and/or mentor new staff or students as assigned. Responsibilities may include hiring, assisting with performance evaluations, and providing instruction on project-related work.
- Audit study operations, including laboratory procedures, to ensure compliance with applicable regulations. Provide leadership in identifying and implementing corrective actions and processes.
- Monitor Institutional Review Board (IRB) submissions and respond to requests and questions.
- Collaborate with Principal Investigators (PIs) and study sponsors. Monitor and report serious adverse events and resolve study queries.
- Provide leadership in identifying, recommending, and implementing improvements to policies and processes and help define best practices.
- Develop study budgets with research staff and Principal Investigators, including identifying standard-of-care versus study-specific procedures.
- Track patient and study-specific milestones and invoice sponsors according to study contracts.
- Ensure regulatory compliance by regularly reviewing study documents and records.
- Work with Principal Investigators to ensure Investigational New Drug (IND) applications are submitted to the FDA when applicable.
- Ensure Institutional Review Board (IRB) renewals are completed on time.






Minimum Requirements

Education & Experience


- Bachelor's degree in a related field and 2 years of experience in clinical research, or an equivalent combination of education and relevant experience.






Knowledge, Skills & Abilities


- Strong interpersonal and communication skills.
- Proficiency in Microsoft Office and database applications.
- Experience working with research protocols and regulatory/governing bodies, including:
- HIPAA regulations
- FDA regulations
- Institutional Review Board (IRB) requirements
- Good Clinical Practice (GCP)
- Knowledge of medical terminology.






Physical Requirements


- Frequently stand, walk, twist, bend, stoop, squat, and perform fine/light grasping.
- Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone, write by hand, and lift, carry, push, or pull objects weighing up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, or lift, carry, push, and pull objects weighing 40 pounds or more.
- Ability to drive during 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.



Position Details


- Employment Type: Full-Time
- Hours: 40 hours per week
- Shift: Day Shift
- Number of Temps Required: 1
- Experience Required: 2+ years
- Working with Minors: No
- Potential Stanford FTE Conversion: Yes






Top 3 Hiring Requirements


- Oncology Treatment Trials experience
- Phase I Clinical Trials experience
- EPIC experience, with clinical research experience in an
onsite healthcare/health institution setting