RN - Clinical Research Nurse - Full Time - Days

Mohawk Valley Health System•City of Utica, NY

About The Position

Under the general direction of the Director of Clinical Research and the assigned Principal Investigator (PI) the Clinical Research Nurse (CRN) supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The CRN works closely with the PI, designated department, sponsor, and institution (s), liaising and providing guidance on the administration of the compliance, financial, personnel and all related aspects of the clinical study. The CRN reports primarily to the Executive Director of Research Director of Clinical Research/Associated PI and interfaces with MVHS administration, compliance and Investigational Review Board.

Requirements

Bachelor's Degree in Nursing/ Life or Health Science, or equivalent experience
3 years of demonstrated sound theoretical and hand’s-on knowledge of the field of clinical research inclusive of planning, executing, and analyzing clinical research trials; performing protocol and site feasibility. clinical research experience in managing the various aspects of clinical trials at the sponsor, sponsor-designee, CRO, affiliate, vendor, and/or site level
Skills: Excellent Communications Skills, Excellent Interpersonal Skills, General Clerical Skills, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher, Microsoft Word, Experienced with electronic IRB submissions, Clinical Trials Management Systems (e.g. CTMS) and Clinical Trials software platforms (Shared Investigator Platform WCG etc.)
NYS RN License

Nice To Haves

Terminal degree in biomedical or educational sciences or equivalent experience
Diversified industry or investigator initiated clinical research experience demonstrating program and resource management across multiple projects, as well as proven leadership abilities

Responsibilities

Facilitate communication of study requirements to all individuals involved in the study. Provide appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log
Adhere to and educates stakeholders with/in the protocol specifics (study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy, human protections)
Collect documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.)
Work with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals
Conduct or participate in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed
Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
Register participants in the appropriate coordinating center (if multi-site study) and in the billing matrix to ensure billing of study procedures to the appropriate funding source
Coordinate participant tests and procedures
Collect data as required by the protocol. Assure timely completion of Case Report Forms
Ensure adherence to study timelines
Maintain adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or MVHS on Investigational Drug/Device Accountability
Complete study documentation and maintain study files in accordance with sponsor requirements and organizational policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
Retain all study records in accordance with sponsor requirements and organizational policies and procedures
Maintain effective and ongoing communication with sponsor, research participants and PI during the course of the study
Assist PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures
Work with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management
Engage with subjects and understand their concerns
Perform other duties as required.