Clinical Research Associate

3 weeks ago

Memphis, Tennessee, United States Urology America, MSO Full time
Job Description

Urology America, MSO is seeking an experienced Research Coordinator to join our team. This is an exciting opportunity to build and lead a growing research department, working closely with a highly motivated group of urologists.

Key Responsibilities:

  • Develop and implement research protocols, ensuring compliance with federal and state regulations.
  • Recruit and manage studies, including budget evaluation and negotiation.
  • Maintain certifications in FDA, GCP, ICH, and other relevant regulations.
  • Obtain and maintain patient consent, ensuring the highest ethical standards.
  • Lead a team of research staff, providing training, delegation of responsibilities, and management.
  • Work directly with patients to screen, consent, and complete necessary exams.
  • Communicate with patients and their families, providing support and education.
  • Manage EMR and data management systems, completing EDC, eCRFs, and maintaining records.
  • Stay up-to-date with relevant software and programs, including trial design and statistical methods.
  • Triage, record, and report adverse events, as well as protocol deviations.
  • Collaborate with IRB, study sponsors, PIs, and Sub-Is, attending necessary meetings and calls.
  • Develop and maintain department SOPs, NDAs, CVs, certifications, and other essential documents.
  • Evaluate and maintain necessary equipment, ensuring HIPAA compliance.
  • Manage study budgets, monitoring invoicing, billing, and payments.
  • Participate in site visits, SIVs, monitoring, and close-out steps.

Requirements:

  • Minimum 5 years of experience in conducting clinical trials.
  • Urology-based clinical experience preferred.
  • Venipuncture experience preferred.
  • Certification via ACRP or equivalent preferred.
  • Proficiency in computer software, including Microsoft Office, EMR, and Practice Management systems.
  • Effective time management and prioritization skills.
  • Excellent communication and interpersonal skills.

Urology America, MSO offers a competitive benefits package, including medical, dental, and vision insurance, 401(k) with employer contributions, and paid time off.

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