Abel Ortega RN/BSN

Experience

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  SeaView Research

  Oct 2003 - Dec 2011

  Registered Nurse

  Now, Quotient Sciences

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  University of Miami

  Dec 2014 - Oct 2016

  Clinical Research Nurse

  • Confirm valid and signed informed consent form each study participant from PI and/or their representative• Obtain or review medical history of study participants for clinical studies• Provide direct hands on care in conducting the clinical study components according to protocol and Investigator specifications (i.e. IV insertions/infusions, phlebotomy, frequent blood or other sampling and or metabolic testing, drug administration, anthropometric measures etc.)• Act as a liaison between CRC and study participants, Investigators and/or study personnel.• Maintain compliance with OSHA, University of Miami and all governing agencies guidelines, regulations and requirements.• Responsible for providing complete and timely reporting of pertinent clinical findings and results to PIs and/or study physicians.• Assist with the scheduling of subject appointments that adhere to the CRC and study needs and coordinate subject’s visits with other professional services. Show less

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  Palmetto Subacute Care Ctr Inc

  Oct 2016 - Apr 2018

  Charge Nurse

  • Responsible for patient’s admission assessments and discharge education.• Responsible for evaluating and monitoring patient care through consultation and direct rounds.• Educate families about patient condition and provide support as needed.• Leveraged exceptional detail orientation and supervisory skills to manage LPNs and CNAs.• Member of the CODE team at facility handling emergency situations as per policy with dignity, competency and care.

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  Quotient Sciences

  Jul 2017 - now

  Study Nurse Coordinator

  • Responsible for administering study medication to study participants. • Responsible for supervising staff and study events on the unit according to protocol requirements. • Responsible for making staff adjustments during absences or others unanticipated work circumstances. • Responsible for monitoring study schedules and reviewing study activities as they progress. • Responsible for reviewing, recording and following adverse events. • Responsible for confirming that a complete screening chart containing informed consents, lab results and Investigator approval is available on the day of admission for every admitted subject. • Responsible for monitoring clinical results, compliance, and/or safety issues which would trigger the exclusion or discontinuation of a participant.• Ability to effectively interact with pharmaceutical company representatives (monitors) and clinical research organizations (CRO) in response to queries during the course of the research study. • Participates in protocol meetings with pharmaceutical company representatives. • Assures that all necessary source documents are available on the unit on a timely basis. • Reviews study source documents for completion. • Assists with new employee (regular and per diem) training by providing orientation to general study procedures and responsibilities. • Familiarity with crash cart emergency procedures. • Assists with other nursing duties as assigned. Show less

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  Nicklaus Children's Health System

  Apr 2018 - Oct 2020

  Clinical Research Nurse Phase 1

  • Coordinates team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) applicable guidelines and regulations, and within budget.• Plans logistical activity for procedures as per protocol and ensures thorough resource planning. Identifies risks on study and ensures that actions are implemented to mitigate risks identified.• Ensures study specific training materials, documents, and records are prepared and delivered or coordinate training, dry runs, simulations and tests as required.• Coordinates and executes the collection. compilation, and analysis of clinical research data from studies conducted by PIs and study teams at Nicklaus Children's and the MCRI. • Interacts with patients and families to recruit study subjects and ensures compliance with protocol guidelines and requirements of regulatory agencies,• Attends and participates in investigator meetings, pre-study visits initiation or coordinator meetings. Produces quality documentation, including completion of assessments within the specified time. Develops updates and implements MCHS Standard Operating Procedures and work flows.• Coordinates and performs study specific regulatory processes in accordance to appropriate federal regulations, ICH GCP guidelines, organization policies and procedures, & study specific protocols.• Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.• Assists principal investigators with protocol reviews, IRB applications, annual reports, budget preparation, internal billing and external publication processes.• Participates in the Informed Consent Process In conjunction with Principal Investigator. Show less

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  University of Miami, Miller School of Medicine

  Jan 2021 - now

  Research Nurse Specialist

  • Responsible for performing research and clinical nursing duties• Conduct investigational product infusion in subjects with COVID-19.• Recruit and determine the eligibility of patients for trial• Explain study requirements and obtain consent forms from study participants.• Infuse research investigational product at UM, JMH and Jackson South COVID-19 units.• Follow up subjects after infusion of investigational product as per protocol• Schedule and conduct study visits• Prepare and maintain medical records, case report forms and study files• Evaluate and monitor patient outcomes and response to care and compliance with research protocols.• Communicate significant changes in patient status with PI, Co-PI and research staff, as well as with the patient's primary care providers.• Other duties as assigned Show less