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Medix™

Clinical Research Nurse

Medix™, Nashville, Tennessee, United States, 37247

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Overview Base pay range

$35.00/yr - $43.00/yr

Direct message the job poster from Medix™

Recruitment Advisor, Clinical Research & Life Sciences at Medix™

Fully Onsite 40 hours a week - Mon-Fri 8-5.

Qualifications include active RN license with oncology experience and at least three years of RN practice, or RN with prior clinical research experience (no oncology required in that case).

Responsibilities

Knowledge and understanding of policies, procedures, and regulations governing human subjects research and incorporation of them in the conduct of research and care of participants

Possesses a basic awareness of the Federal regulations governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, HIPAA)

Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse events according to institutional policies and federal regulations

Possesses a basic awareness of client policies and regulations governing the protection of human subjects

Knowledge and understanding of the management and implementation of clinical trial operations

Understands the procedures required of each study protocol and obtains training needed to perform or assess required procedures

Prepares and stores critical documents required to be maintained and provided to the sponsor before, during, and after the conduct of a clinical trial

Performs packaging and shipping of study medication and specimens to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines

Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation, and procedures

Participates in the determination of eligibility and recruits candidates for study participation

Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through effective screening and recruitment documentation

Provides education and training to appropriate personnel and participants in research methodology and procedures

Maintains open and positive communications with investigators, participants, co-workers, other departments, and sponsors

Digests complex clinical information to ensure documentation is accurate and complete, and that procedures contain appropriate safeguards

Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner

Understands standard of care versus research and assesses need for additional protections for participants and research data accuracy

Utilizes nursing skills to identify participant and study problems, develops solutions, and ensures goals are met

Contributes to quality improvement through ongoing assessment and planning for improvements

Serves as an advocate for human subjects by maintaining communication with investigators, sponsors, participants and regulatory bodies

Assesses and evaluates potential participants to ensure appropriate enrollment in trials

Participates in ongoing informed consent discussions with subjects and families

Uses nursing skills to complete research procedures including recruitment, scheduling, visits, assessments, laboratory tests, and medication handling

Documents and uses the nursing process to plan and deliver safe, age-appropriate care in the research setting

Performs protocol procedures and reports any deviations to the Principal Investigator for review

Maintains accurate records of recruitment efforts and data collection

Monitors for adverse events and reports them to the principal investigator and regulatory authorities as required

Conducts literature reviews to stay current with developments affecting risk/benefit in the research context

Engages in ongoing training and professional development to sustain and enhance performance

Participates in and/or leads opportunities for continuing education and certifications relevant to clinical research nursing

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with applicable federal, state and local laws including city and state fair chance regulations.

This position is subject to a background check based on job duties, which may include working with vulnerable populations and handling confidential information.

Qualifications

Active RN license

Oncology experience and at least three years of RN practice, or RN with prior clinical research experience (no oncology required if the candidate has clinical research background)

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