Job Description

JOB SUMMARY

A Clinical Research Nurse/LPN is a member of the research team who serves participants in clinical trials with direct patient care. This position is responsible for maintaining tight regulatory control over the health and safety of patients, as well as gathering and analyzing data for scientific study.

RESPONSIBILITIES

• Perform clinical functions i.e. phlebotomy, monitoring vital signs of study participants, etc., when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
• Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow—up, collect patient/ research participant history, collect, and maintain source documentation, perform data entry and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events.
• Under the supervision of an investigator, conduct health assessments as medically necessary or required per protocol to assess or resolve adverse events, safety, and general health of study participants.
• Monitor study participants for adverse events and report any adverse events to the principal investigator, and study coordinator, if applicable.
• Administer study interventions and treatments as directed by the principal investigator, if appropriate for scope of license.
• Prepare and monitor administration, usage, and documentation of investigational products and other required treatments in clinical trials.
• Perform and adhere to clinical functions commensurate with pertinent nursing license scope of practice (i.e., keep within state Board of Nursing scope of practice for license as an LPN, RN, etc.)
• Maintain compliance with required hospital and unit-specific training competencies as well as an active nursing license status with the state Board of Nursing
• Perform diagnostic tests and monitor participants’ health through regular assessments.
• Observe, document, and report any changes in participant’s health status, and provide clinical care where necessary.
• Respond to emergencies and provide medical care as necessary and/or directed by a study investigator.
• Maintain frequent communication with research assistants and research coordinators regarding enrollment and tasks.
• Assist in the informed consent process of research subjects, if appropriate for scope of license.
• Support and advocate for the safety of research subjects.
• Collect, process, and ship laboratory specimens.
• Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines.
• Provide training to new investigator/site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
• Performs all additional duties as assigned.

Qualifications

• Current RN/LPN licensure in the state of employment.
• Associate Degree in Nursing from an accredited school of nursing.
• Certification in Clinical Research Coordination (CCRC) preferred.
• BLS required
• Three years prior experience in a health-related clinic or research setting
• Proficient in the use of Microsoft Office applications
• Understanding of medical terminology
• Strong organizational skills
• Working knowledge of clinical trials
• Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to detail.
• Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients.
• Practice a high level of integrity, honesty, and in maintaining confidentiality.

Benefits (full-time)

• Competitive Salary
• Health Insurance
• Dental Insurance
• Disability Insurance
• Life Insurance
• Paid Time Off
• Vision Insurance

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