Clinical Research Nurse 2 - Full-Time, Miami FL

University of Miami•Miami, FL

5d•Onsite

About The Position

The Clinical Research Nurse 2 ensures the integrity and quality of clinical research studies are maintained and conducted in accordance with practice guidelines, federal and sponsor regulations, and institutional policies and procedures. Additionally, the Clinical Research Nurse 2 plays a key role in the recruitment of participants and achievement of research objectives.

Requirements

Bachelor’s degree in relevant field required
Minimum 3 years of relevant experience required
Valid State of Florida RN license required
Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Teamwork: Ability to work collaboratively with others and contribute to a team environment.
Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
Bachelor’s degree in nursing (BSN) from an accredited Nursing school.
Valid Florida Registered Nurse Licensure (RN)
Basic Life Support Certification (BLS)
Pediatric Advance Life Support Certification (PALS)
Advanced Cardiovascular Life Support Certification (ACLS)
Minimum 3 years of relevant experience in Nursing.
Minimum 3 years clinical research experience.

Responsibilities

Assesses, troubleshoots, and reports problems with data collection to appropriate managing staff.
Identifies desired research outcomes and evaluates and monitors subjects’ responses.
Conducts initiation visits and registers patients in clinical studies.
Performs study data collection and entry using charts, correspondence, medical records, and relevant communications. Identifies and procures equipment and supplies needed to fulfill project requirements.
Educates staff and subjects about protocols, treatment, possible side effects, and complications. May also collect and handle specimens as required by individual study protocols.
Prepares and processes new research proposals and amendments and continually monitors applications and adverse events.
Assists with study completion, data lock, study closeout, and archiving of study files to ensure completeness and continuity of all study data.
Completes ongoing checks of clinical data entered on the case report forms to ensure accuracy and revises any discrepancies.
Adheres to University and unit-level policies and procedures and safeguards University assets.
Work with CTRS lead nurse to ensure that nursing services, policies, and procedures are in alignment with the regulatory and compliance guidelines at institutional and federal levels.
Participate in the oversight of participant visit scheduling to ensure adequate coverage.
Assist the lead nurse in weekly meetings of clinical research staff to ensure that challenges and issues are addressed promptly and efficiently.
Assist with review and updates of SOPS relating to the CTRS as needed.
Participate in the onboarding of all new CTRS clinical research nurses and medical assistants.
Partner with Lead Nurse and participate in CTRS in-service protocol meetings.
Maintain required training, credentialing, competencies, and other requirements as specified by MSOM, UHT, JHS, and other relevant entities (including Citi Training, Bio Safety, Lab Safety, OSHA, and HIPAA).
Participate in quality review to ensure accurate and compliant documentation.
Reviews Serious Adverse Events documented and reported per the protocol and regulatory requirements for protocols serviced by the CTRS.
Work closely with principal investigators and staff across multidisciplinary teams to ensure seamless protocol execution and high-quality patient care.
Demonstrate knowledge and understanding of policies, procedures, and regulations governing human subject research.
Implementation of clinical trial protocols requiring CTRS services, ensuring adherence to Good Clinical Practice (GCP), FDA, HIPAA, and IRB regulations.
Assess and document protocol-related patient compliance and response to treatment according to physician treatment orders.
Educate staff about protocols related to treatment, possible side effects, and complications.
Enter research-related orders and results in UChart / Cerner as per protocol.
Receive Investigational Products from Research Pharmacy and administer the drug according to physician treatment orders.
Serve as primary contact for PIs, staff, and departments regarding protocol-related issues to ensure a safe environment for patients while maintaining compliance and adhering to regulatory guidelines.
Assist in participant recruitment, screening, informed consent process, and retention efforts when required.
Maintain a safe working environment by adhering to established policies and procedures within the unit.
Ensure alignment with the University's strategic mission, vision, values, and Code of Business Conduct in planning research-related patient care and clinical research.