About The Position

The Clinical Research Registered Nurse ensures the quality and accuracy of clinical trials and that they are conducted in accordance with applicable regulations and IRB approvals. The role is primarily responsible for completing study visit procedures and collecting information from research participants according to study protocols, while protecting participants’ health, safety, and welfare and serving as their advocate. The nurse promotes, educates about, and enrolls participants in clinical trials; maintains accurate patient records and organized study files; manages data for participants on study and in follow-up; monitors data for trends and protocol violations; prepares for research audits; supports regulatory requirements; and submits required data forms to relevant groups within required time frames. The nurse coordinates studies with the research team, reviews protocols before study initiation, and works with research physicians and study staff to complete study activities on time. The role includes recruiting and assessing potential participants, documenting medical history and eligibility, ensuring protocol compliance at each study visit, maintaining regulatory and source documentation, and communicating study requirements with internal and external collaborators, sponsors, monitors, investigators, and participants.

Requirements

  • Current Registered Nurse license in the applicable state.
  • Current American Heart Association BLS for Healthcare Provider Card.
  • Bachelor’s degree in Nursing from an accredited college or university.
  • Experience or knowledge in disease prevention, education, risk assessment, screening programs, and physical examination.

Nice To Haves

  • At least two years of experience in clinical research trials.
  • In South Carolina, a valid driver’s license with a good driving record.

Responsibilities

  • Coordinate clinical research studies in a team approach according to study protocols and applicable IRB and FDA regulations.
  • Review research protocols before study initiation and collaborate with the research team on effective study management strategies.
  • Coordinate with research physicians and study staff to ensure timely completion of study activities.
  • Review and document each participant’s study visit to ensure compliance with the study protocol.
  • Participate in recruitment and selection of study participants, including interviewing candidates and documenting medical history to assess eligibility.
  • Manage accurate and complete data for research participants on study and in follow-up.
  • Monitor data for trends, protocol violations, and patterns that may require action.
  • Review regulatory requirements and support site compliance and regulatory staff in maintaining regulatory documents.
  • Collect, document, and enter data accurately and on time.
  • Create and maintain source documentation and research records; transcribe collected data into study documentation completely and accurately.
  • Record research subject activities to facilitate tracking of sponsor payments.
  • Communicate study-specific requirements and collaborate with internal and external parties, including sponsors, monitors, investigators, study staff, and participants.
  • Prepare for research base audits and assist with regulatory requirements.
  • Submit required data forms to relevant groups within required time frames.

Benefits

  • Competitive pay, incentives, referral bonuses, and a 403(b) with employer contributions when eligible.
  • Medical, dental, vision, and prescription coverage; HSA/FSA options; life insurance; mental health resources; and discounts.
  • Paid time off, parental and FMLA leave, short- and long-term disability, and backup care for children and elders.
  • Tuition assistance, professional development, and continuing education support. Benefits may vary based on market and employment status.
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