Research Registered Nurse

Summary GENERAL

SUMMARY:

Essential in managing clinical research studies, requiring adaptability to various medical areas for effective participant evaluation and support of diverse protocols. Responsible forensurinjg the safety, rights, and well-being of participants participating in clinical research studies. This role integrates clinical expertise with regulatory compliance to support ethically conducted research while maintaining the highest standards of patient-centered care.

* Commits to the mission, vision, beliefs and consistently demonstrates our core values.

Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.

Assists with the preparation of Institutional Review Board (IRB) applications including protocol and informed consents and obtaining approval to conduct the study.

Maintains appropriate correspondence with the IRB, including adverse events, protocol deviations, annual renewals, and protocol amendments.

Designs and develops accurate source materials and workflow procedures in accordance to study protocols and standard operating procedures.

Schedule and conduct interviews along with an investigator for potential participants, obtain informed consent, and enroll subjects to the research study.

Performs medical tests, including, but not limited to, vital signs, imaging studies, electrocardiograms, and phlebotomy.

Disperses and administers investigational medications and performs participant assessments during and after clinic visits to determine presence of side effects; notifies investigator of critical findings/issues.

Provides participant education and medical information to ensure understanding of proper medication dosage, administration, and management of their disease.

Learn and troubleshoot medical devices used in studies, train medical center and clinic staff on device usage, and ensure safety.

Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.

Provides accurate and timely data collection to ensure data quality as required by study protocols and Standard Operating Procedures. This includes all documentation, data entry, and reporting in both sponsor and EMR databases.

Collaborate with multidisciplinary teams (including but not limited to: surgeons, surgery staff, procedure/diagnostic/clinic schedulers, cardiology , radiology and bedside and clinic staff, etc.) to support study workflows, scheduling of procedures, and managing participant appointments.

Ensures appropriate credentialing and training of the entire Bryan Health team.

Perform rapid eligibility assessment and enrollment for acute care emergency research studies. Managing complex protocols in critical care settings, coordinating with intensivist, bedside nursing and pharmacists.

Ensures timely monitoring of post-operative outcomes and adverse events documentation.

Ensures maintenance of regulatory documents in accordance with Bryan Health standard operating procedures and applicable regulations.

Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsors, monitors, investigators, and study participants.

Ensures compliance with research protocols, by providing ongoing quality control audits, maintaining investigational product accountability.

Participates with the investigator and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.

Adhere to HIPAA requirements and maintain confidentiality.

Develop…