Amber Joanne Abaigar, BSN, RN

Asses patient's need while complying with HIPAA laws and prevent information breaches. (More details available upon request.)

Administered medications and treatments in accordance with established protocols. Perform patient education. Triage patient phone calls. Monitor patient's laboratory values. (More details available upon request.)

Conducts utilization reviews to evaluate the medical necessity, grievances and appeals. Assist with medication prior authorizations and prescription requests. (More details available upon request.)

Administered medications and treatments in accordance with established protocols. Perform patient education. Triage patient phone calls. (More details available upon request.)

*Institutional Review Board Administrator and Clinical Research Professional role performed duties closely aligned to the role of a Research Nurse. IRB is the clinical research regulatory body of the hospital, ensuring clinical trials adheres to standard protocols and the clinical trial participants are safe and protected.

Responsibilities:

CLINICAL TRIAL PARTICIPANT MANAGEMENT:

Support IRB in ensuring the following activities adheres to safety and ethical standards of the hospital and national regulatory bodies:

• Conduct of recruitment and outreach activities.
• Screening and recruiting of potential participants for clinical trials.
• Conduct of informed consent discussions / obtain informed consent.
• Coordination of study visits with enrolled participants and study personnel.
• Conduct of study visit procedures and assessments per protocol.
• Performance of phlebotomy and peripheral IV placement.
• Facilitation of study drug order preparation and verification.
• Administration of study medications per protocol.
• Conduct of study-related patient education.
• Completion of specimen processing and shipping.
• Answer and resolve participant queries in consultation with PI.
• Performance of phone triage for questions and acute clinical issues and conduct phone assessments as required per protocol.

DOCUMENTATION:

• Document study procedures and assessments in source documents and case report forms.
• Organize and maintain study documents.
• Ensure completeness of documents during IRB submissions by Principal Investigator / Physician.

ADMINISTRATIVE TASKS:

• Ensures that the informed consent submitted to IRB by principal investigators is ethical and complete.
• Manage inventory and procurement of IRB supplies.
• Use of ethical research conduct, research educational, review of informed consent, adverse event monitoring, adherence to study requirements according to protocol; monitor study drug according to protocol; help monitor and/or perform psychokinetic studies as detailed in protocol)
• Support department-level programs focused on patient safety in clinical trials.
  Conducts data abstraction and analysis to identify trends and opportunities in safety adverse events.
• Recommend and implement educational initiatives, policy changes, and system improvements.
  Helps clinical teams in review protocol completion for IRB submission.
• Assist with writing abstracts and preparing presentations for clinical staff.
  Performs a variety of technical and administrative duties on clinical research studies.
• Supports programs on the safety of clinical trial patients.
  Gathers data and performs analysis to identify safety adverse effects of patients participating in clinical trial.
  Recommend and implement educational training programs, policy changes, and system improvements.
• Assist in drafting the IRB (Institutional Review Board) Standard Operating Procedures (SOP) and drafts minutes of the meeting Keeps abreast with latest trainings and educational programs and related to safety of clinical trials participants, FDA guidelines and Good Clinical Practice Guidelines.
• Monitor safety adverse events of clinical trials
• Conduct ethical research practices ensuring compliance with protocols and regulatory standards.
• Monitors and analyzed safety adverse events during clinical trials, maintaining patient welfare as a priority.
• Develops and implemented educational training programs to enhance team knowledge on safety protocols and Good Clinical Practice guidelines.
• Assists physician-investigators in the preparation for Institutional Review Board submissions, ensuring protocol ethics.
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