Intermittent Research Nurse

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Job description

Position Summary:

The Research Nurse is an integral part of the research team, ensuring the integrity and quality of clinical research is maintained and conducted at the Ohio University Heritage College of Osteopathic Medicine's Clinical & Translational Research Unit ( CTRU ) in accordance w/ federal, state, and local regulations, Institutional Review Board ( IRB ) approvals, and policies and procedures.
There are two key duties of the Research Nurse. The first duty is to independently perform medical tasks or assist with medical procedures performed in the clinical research setting. The clinical research nurse must be prepared to encounter diverse populations with a variety of conditions and first-in-human agents. The clinical research nurse must constantly learn new skills while building on prior knowledge from studies initiated in the past. This position is integral to maintaining safety and order within protocol requirements, while promoting retention of the participant through excellent bedside care and supporting the volunteer nature of research studies. The second key duty is being responsible for Study Coordination, which entails coordinating and assisting with day-to-day conduct of clinical research studies. The studies include both sponsored clinical trials (Phases I-IV) and investigator-initiated research studies conducted through the Ohio University's Heritage College of Osteopathic Medicines CTRU .

Primary Responsibilities:

Performing Nursing and Medical Research Tasks and Assisting with Medical Research Procedures:
Clinical research studies vary widely but many require some type of medical task or procedure to be performed. The clinical research nurse must have a demonstrated track record of technical expertise and experience in performing invasive tasks such as setting and maintaining IV lines under time critical conditions, troubleshooting equipment, in addition to:
· Collecting samples (e.g., venipuncture, fingersticks, urine, fecal)
· Assisting in medical procedures including biopsies, insulin clamping procedures, conscious sedation, etc.
· Administering drugs (e.g., IV, injection, oral, etc.) distribution of investigational drug or intervention and provides patient teaching regarding administration or procedures, as necessary
· Obtaining and processing collected samples (e.g., obtaining blood via venipuncture, blood processing, drug infusion, conscious sedation, biopsies, etc.)
· Performing medical tests (e.g. vital signs, imaging studies, electrocardiograms)
· Ensuring compliance with each study's protocol by providing thorough review and documentation at each subject study visit
· Providing education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment
· Documenting medical data to capture protocol requirements
· Obtaining authorization for release of medical information as necessary and assuring follow-up care/continuity of care with participant's personal care provider

Study Coordination:

As Study Coordinator, ensures assigned studies are conducted in accordance with the Food and Drug Administration ( FDA ), Office for Human Research Protections ( OHRP ), Good Clinical Practices ( GCP ) guidelines and approved Institutional Review Board ( IRB ) protocols. Coordinates all aspects of the daily operation of clinical studies. Examples of these duties include but are not limited to:

· Ensuring site compliance with all research protocols and regulatory requirements
· Providing ongoing quality control audits and maintaining ongoing investigational drug accountability or other protocol specific accountability measures
· Assisting with recruitment, consent, and compensation of eligible research subjects per the protocol
· Developing accurate source materials and ensuring compliance from research team
· Providing accurate and timely data collection, documentation, entry, and reporting according to IRB approved protocol
· Maintaining confidentiality of subject Case Report forms, source documents and other study data per HIPAA and CTRU standards and study Principal Investigator and/or sponsor standards
· Ensuring appropriate credentialing and training of the entire research team
· Supporting the maintenance of regulatory documents in accordance with federal, state, and institutional policies, procedures, or other applicable regulations
· Communicating specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
· Coordinating study start-up and close-out activities, which includes coordinating the site initiation/close-out visit, completing investigational product accountability, receipt/return of equipment and completing reports to Principal Investigator and/or sponsor
· Coordinating and conducting data quality activities including interim monitoring visits and data queries
· Collecting and storing research records upon study completion, notifying PI and/or sponsor of storage location, and assisting with maintaining records via multiple and varying technology methods (e.g., cloud based, EDC , REDCap, etc.)
· Responding and reporting adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions to appropriate parties within the appropriate time frames and in accordance with ICH - GCP and other regulations

Other duties including but not limited to:

· Participating in Business Continuity Planning activities for the CTRU
· Participating in regular research team meetings and ORG or CTRU team meetings to discuss current activities or planning activities
· Attending assigned training and maintaining proficiency with required technologies and procedures
· Traveling occasionally to promote CTRU activities or sponsor study training meetings
· Providing training or presentations to university, community, or other groups

The successful candidate will have excellent attention to detail and organizational skills-strong interpersonal and communication skills. The ability to work well under pressure, multi-task, and manage deadlines. Knowledge of GCP , federal, state and local regulations, Including HIPAA policies and procedures. Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative. Must have a professional demeanor, strong communication skills with the public as well as physicians, investigators, and co-workers. Ability to work well independently as well as in a team environment. Nursing competency skills per scope of practice [i.e., performing vital signs, drug administration (IV, injection, oral, etc.), assisting with medical procedures (biopsies, surgical, etc.]
Must be proficient in Microsoft Office Word and Excel, and databases used in research environment (preferred), or have a willingness to learn and demonstrate proficiency within six months of hire.

Job Requirements:
Minimum Requirements:
-Bachelor's degree- BSN or BS with RN certification
-1 year of work related experience
-Valid RN license from the State of Ohio
-Valid CPR /First Aid Certification

Preferred Requirements:
-2 years of clinical research experience
-Experience using databases used in research environments