Clinical Research Nurse I

ICONMA, LLC • United States, United States • 23h ago

Our Client, a Pharmaceuticals company, is looking for a Clinical Research Nurse I for their Miramar, FL location. Responsibilities:

The Clinical Research Nurse is a primary point of contact for study participants, the Primary Investigator (PI), the Clinical Study Manager (CSM), and Department Managers in all study conduct and/or participant-related matters on the clinical research unit floor.

Performs procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP's), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable

Overseas and monitors the well-being and safety of study participants by active assessment as well as by serving as a visible point of contact at all times

Facilitates verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensures appropriate follow-through

Assists the PI with the review of laboratory data results for both the selection and randomization of study participants and for the monitoring of safety parameters while study conduct is ongoing

Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs), ensures proper documentation and reporting of all AEs, including follow up of open AEs when subjects are not in-house, and provides any appropriate clinical care or instructions to subjects, as directed by the PI or as deemed medically necessary by their professional judgment

Continuously communicates the progress of study conduct to PI, CSM, and members of the clinical study team through various methods of communication

Immediately notifies the PI, CSM, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event (SAE) by a study participant and initiates documentation of the event

Enforces rules and regulations with study participants and handles participant complaints efficiently and effectively, maintaining participant satisfaction

Maintains compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study

In the absence of the Clinical Study Manager, performs as the floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor

Demonstrates professionalism and provides leadership to the various members of the clinical study team

Administers study medication according to study protocol, demonstrates thorough understanding of study medications, and administers concomitant medication as directed by the PI and maintains accurate and timely documentation of the process

Coordinates with the scheduling department to ensure coverage of clinical conduct activities

Works with CSM and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction and feedback as needed

Oversee the completion of all End of Study or Early Termination activities by study participants, inclusive of follow up for the close-out of any outstanding items (i.e. AEs, physical exams, lab repeats, etc.) after subjects have been discharged from the clinic

Provides administrative and operational support to ensure successful conduct of study protocols

Requirements:

Education A nursing degree and in-state licensure is required.

One to two (1-2) years of experience in a clinical research environment

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific experience listed above.

Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)

Possesses leadership skills and abilities

Able to provide excellent customer service, with experience in public relations

Able to communicate professionally and effectively both verbally and in writing with participants from diverse backgrounds

Able to work independently and handle multiple competing priorities

Able to multi-task working within tight deadlines

Able to function independently within a team environment

Possesses excellent organizational and time-management skills and a strong attention to detail

Why Should You Apply?

Health Benefits

Referral Program

Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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