Clinical/HC Research Associate - Cardiology

University of IowaIowa City, IA
Onsite

About The Position

This position applies clinical skills requiring a RN license to deliver and evaluate research protocols in adult cardiac electrophysiology. Key areas of responsibility include research/clinical activities, protocol development, contracting and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility.

Requirements

  • A Bachelor's degree in Nursing or an equivalent combination of education and experience is required.
  • A Current, valid Iowa Registered Nurse license is required.
  • ACLS certification is required.
  • Ability to work some weekends, evenings, and nights per study protocol as required.
  • Excellent written and verbal communication skills are required.
  • 6 months of nursing experience is required.
  • Knowledge of cardiovascular medicine procedures and cardiovascular medicine terminology is required.
  • Recent (within 1 to 5 years) clinical nursing experience is required.
  • Previous nursing experience with the cardiovascular medicine diseases patient population is required. This includes prior experience with telemetry monitoring and IV drug therapy and placement and administration of cardiac specific medications.

Nice To Haves

  • 6 months of research experience is desirable.
  • Proficient in using electronic medical record systems is desirable.

Responsibilities

  • Perform clinical/health care research activities for EP research which includes bedside management of subject participants before, during and post interventional procedures.
  • Research activities involve the coordination and collection of research data for subjects with arrhythmias, permanent pacemakers or implantable cardiac defibrillators.
  • Prepare and participate in monitoring visits; may perform activities such as patient assessments and review of medical history and medications prescribed.
  • Assure compliance with study protocol.
  • Obtain and process clinical trial specimens.
  • Dispense study-related medications and document effects.
  • Assist participants with problems related to their protocol therapy such as consultation when calling reporting concerns related to: returning for emergency evaluation in the case of side effects, assisting with emotional problems, questions related to treatment procedures or other related issues.
  • Maintain a comprehensive understanding of the study protocol in order to recruit qualifying subjects, administer investigational product, collect required study data and maintain subject safety.
  • Assist in protocol development and provide input into descriptions of routine research procedures.
  • Resolve queries.
  • Perform randomizations.
  • Develop study materials.
  • Assure study visit compliance within window of visit schedule.
  • Screen, recruit, and obtain informed consents for clinical trials/studies.
  • Provide thorough explanation about clinical trial to potential subjects. Seek out clarification from principal investigator or sub investigator when necessary.
  • Assist principal investigator to determine subject eligibility.
  • Schedule trial related procedures and visits within required study protocol windows.
  • Assist with subject assessments during study participation.
  • Notify principal investigator or sub-investigator of an abnormal finding when assessing the subject and schedule follow-up as requested.
  • Collect and enter concise clinical research data required by the sponsors according to the sponsors’, Institutional Research Board and Good Clinical Practice requirements
  • Assist with determining validity of data obtained.
  • Collect and maintain regulatory documents from subjects and assist in preparation of required regulatory forms and documentation according to protocol.
  • Report any reportable events to appropriate party.
  • Adhere to institutional policies and guidelines.
  • May provide functional and/or administrative supervision.
  • Accept direction, assignments, feedback, coaching and counseling to assure outcomes are achieved.
  • Provide direction, assignments, feedback, coaching and counseling to assure outcomes are achieved.
  • Assist in budget development and management of resources/supplies for study.
  • Contribute to identification of increased cost/inefficient spending and cost containment measures.
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