Research Specialist II – CIBMTR Data Coordinator - FT - Days - MCI

The CIBMTR Data Coordinator is responsible for consenting hematopoietic transplant and cellular therapy patients and for the collection, review, abstraction, validation, and timely submission of required patient data to the Center for International Blood and Marrow Transplant Research (CIBMTR). The position reviews electronic medical records, completes required pre-transplant, infusion, follow-up, disease-specific, and adverse event forms, monitors reporting deadlines, resolves data queries, and maintains accurate patient records, tracking tools, and databases. The coordinator collaborates with physicians, advanced practice providers, nurses, BMTs, clinical research, data, and quality personnel to obtain complete clinical information and supports CIBMTR and FACT accreditation activities, internal and external audits, quality improvement initiatives, and regulatory compliance while maintaining patient confidentiality in accordance with HIPAA and institutional policies. The coordinator also participates in departmental meetings and continuing education activities to support ongoing program quality and compliance

Responsibilities

Obtains medical history, monitors patient care, assess ongoing patient status and monitors treatment side effects; Documents patient/study results using the electronic medical record (EPIC) and completes data requirements for sponsors; Communicates patient/study results on an on-going basis to research team; Screens and consents patient's for clinical trials using Good Clinical Practice (GCP) guidelines; Provides patient and family support and education regarding protocol related drugs and procedures; Conducts Initiation, monitoring and close out visits with sponsors; Collaborates to ensure compliance with local, state and federal regulations and standards; Assists with preparing for and responding to audits; Participates in audits; Reports Adverse events and resolves data queries with sponsors; Processes and ships study required specimens; Coordinate activities of multidisciplinary team that cares for the patient as well as patient visits and necessary testing

Requirements

Accredited Program (Required); Foreign Medical Doctor Degree (FOREIGN MD DEGREE) - Classroom Training (CLASSROOM TRAINING); Registered Nurse Compact License (RN LICENSE COMPACT) - Compact RN Multistate; Registered Nurse License (RN LICENSE) - State of Florida (FL); One (1) year of clinical experience; At least two (2) years of clinical research experience; Ability to travel for protocol related investigator meetings and research related training; Critical thinking skills; Effective communication; Decisive judgement; Ability to work with minimal supervision; Ability to work in a stressful environment; Proof of Graduation certificate for foreign trained MDs or equivalent clinical programs; Graduate from an accredited professional nursing program or Foreign Medical doctor program or Equivalent relevant degree