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Clinical Research Coordinator 2 Position

1 month ago

Stanford, California, United States Stanford University Full time
Job Title: Clinical Research Coordinator 2

Stanford University is seeking a highly motivated and experienced Clinical Research Coordinator 2 to join our team. As a key member of our research team, you will be responsible for independently managing significant and key aspects of large and multiple research studies at both Stanford's main campus and satellite sites.

Key Responsibilities:
  • Oversee subject recruitment and study enrollment goals, developing effective strategies for promoting and recruiting research participants and retaining participants in long-term clinical trials.
  • Oversee data management for research projects, developing and managing systems to organize, collect, report, and monitor data collection, extracting, analyzing, and interpreting data.
  • Develop project schedules, targets, measurements, and accountabilities, leading team meetings and preparing/approving minutes.
  • Formally supervise, train, and/or mentor new staff or students, 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, providing leadership in identifying and implementing corrective actions/processes.
  • Collaborate with principal investigators and study sponsors, monitoring and reporting serious adverse events, and resolving study queries.
  • Provide leadership in determining, recommending, and implementing improvements to policies/processes, defining best practices.
  • Develop study budget with staff and principal investigator, identifying standard of care versus study procedures, tracking patient and study specific milestones, and invoicing sponsors according to study contract.
  • Ensure regulatory compliance, regularly inspecting study documents to ensure ongoing regulatory compliance.
  • Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable, ensuring Institutional Review Board renewals are completed.
Desired Qualifications:
  • Previous experience with interventional drug and device studies.
  • Ability to work independently on multiple, complex research studies.
  • Excellent oral and written communication skills.
  • Strong background in clinical trials research, including protocol design, screening and recruitment of potential participants, identification and communication of adverse health effects.
  • Must be flexible, dependable, and able to handle multiple priorities with conflicting deadlines.
  • The position has a need for flexible work hours which may involve day or nighttime coverage. Hours will change based on the research needs of the Division.
  • Must be able to work at multiple sites.
  • Previous patient care experience. 200 documented hours.
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 & Abilities:
  • Strong interpersonal skills.
  • 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.
  • Comprehensive understanding of scientific principles.
  • General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications.
  • Strong analytical skills and excellent judgment.
  • Ability to maintain detailed records of clinical research and outcomes.
  • Ability to work under deadlines with general guidance is essential.
  • Excellent organizational skills and demonstrated ability to accurately complete detailed work.
Certifications & Licenses:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License.

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.
Working Conditions:
  • This is an on-site position and may require extended or unusual work hours based on research requirements and business needs.
  • 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 diseases and infections.