Clinical Research Specialist II

2 weeks ago

Stanford, California, United States Stanford University Full time

Overview:
The Department of Neurology at Stanford University is in search of a Clinical Research Specialist II to lead clinical investigations and manage increasingly intricate projects independently.

Key Responsibilities:
Take charge of critical elements of a large-scale study or manage all facets of multiple smaller research initiatives.

  • Direct subject recruitment and achieve study enrollment objectives. Formulate effective strategies for attracting and retaining research participants in long-term clinical trials.
  • Supervise data management for research initiatives. Create and oversee systems for organizing, collecting, reporting, and monitoring data. Analyze and interpret data effectively.
  • Establish project timelines, targets, metrics, and responsibilities as assigned. Facilitate team meetings and prepare/approve meeting minutes.
  • Provide formal supervision, training, and mentorship to new personnel or students as assigned, which may include hiring and assisting with performance evaluations.
  • Conduct audits of operations, including laboratory practices, to ensure adherence to relevant regulations; lead efforts in identifying and implementing corrective measures.
  • Oversee Institutional Review Board submissions and address inquiries and requests.
  • Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study-related queries.
  • Lead initiatives to recommend and implement enhancements to policies and processes; define best practices.
  • Develop study budgets in collaboration with staff and principal investigators, distinguishing between standard care and study procedures. Monitor patient and study-specific milestones, invoicing sponsors according to study agreements.
  • Ensure compliance with regulatory standards. Regularly review study documentation to maintain ongoing regulatory adherence.
  • Work with principal investigators to ensure Investigational New Drug applications are submitted to the FDA when necessary. Ensure timely completion of Institutional Review Board renewals.

Qualifications:
Education & Experience:
A Bachelor’s degree in a relevant field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills, and Abilities:
Exceptional interpersonal skills.
Proficiency in Microsoft Office and database management applications.
Familiarity with research protocols and regulatory bodies, including HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
Understanding of medical terminology.

Certifications & Licenses:
Preferred certification from the Society of Clinical Research Associates or the Association of Clinical Research Professionals. A valid California Driver's License may be required.

Physical Requirements:
Frequent standing, walking, twisting, bending, stooping, squatting, and fine motor skills are necessary.
Occasional sitting, reaching above shoulders, performing desk-based computer tasks, using a telephone, and writing by hand. Ability to lift, carry, push, and pull objects weighing up to 40 pounds.

Working Conditions:
This position may require working in environments with hazardous materials and potential exposure to chemicals, blood, bodily fluids, or tissues, as well as risks associated with contagious diseases and infections. Extended or unusual work hours may be necessary based on research demands.

Commitment to Safety:
Demonstrates a commitment to personal responsibility and a culture of safety; communicates safety concerns and promotes safe practices based on training and lessons learned.

Stanford University is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

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