Clinical Research Coordinator

3 days ago

Memphis, Tennessee, United States Urology America, MSO Full time
Job Title: Clinical Research Coordinator

We are seeking an experienced Clinical Research Coordinator to join our team at Urology America, MSO. As a key member of our research department, you will play a crucial role in building and leading our research efforts.

Responsibilities:
  • Build and lead our research department in scope, size, reputation, and professionalism.
  • Assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, and communication with study sponsors.
  • Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations.
  • Obtain and maintain consent of patients with the highest ethical standards.
  • Work with other research department staff in a leadership role, including management, training, delegation of responsibilities, hiring, etc.
  • Work directly with patients to screen, consent, take history, complete necessary exams, including EKG, blood draw, vitals, etc.
  • Communicate with and support patients and their families as necessary.
  • Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records.
  • Maintain knowledge of relevant software/programs.
  • Have a basic and working knowledge of trial design, statistical methods, etc.
  • Triage, record, and report adverse events. Record and report any protocol deviations.
  • Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
  • Create and maintain department SOPs, NDAs, CVs, certifications, etc.
  • Evaluate, purchase, maintain necessary equipment.
  • Maintain HIPAA compliant communication and confidentiality, at all times.
  • Maintain study budgets and monitor invoicing, billing, and payments.
  • Participate in site visits, SIVs, monitoring, etc.
  • Complete necessary study close-out steps and documentation.
  • Assist with other duties assigned.
Qualifications and Skills:
  • Must have knowledge of and experience with relevant federal and state regulatory guidelines.
  • Must have > 5yrs experience with conducting clinical trials.
  • Urology based clinical experience preferred.
  • Clinical experience preferred.
  • Venipuncture experience preferred.
  • Experience with evaluating and implementing study protocols and budgets.
  • Certification via ACRP or the equivalent preferred.
  • Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
  • Effective time management and the ability to prioritize work.
  • Excellent communication skills and the ability to interact with all levels of management, staff, and physicians.

We offer a competitive benefits package to eligible employees, including medical, dental, and vision insurance, short and long-term disability, 401(k) with employer contributions and profit sharing, paid time off, group term life insurance, health care and dependent care flexible spending accounts, health savings account, employee assistance program, competitive wages, paid holidays, and no weekends.

Apply now to join our team and take the first step towards a rewarding career in clinical research

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