Job Information
Ohio University Intermittent/PRN Senior Research Nurse, CTRU (Pool) - Heritage College of Osteopathic Medicine in Athens, Ohio
Job Description:
About the Heritage College of Osteopathic Medicine:
Mission:
We pride ourselves on our strong focus on our mission: training osteopathic primary care physicians to serve Ohio.
Our medical school educates physicians committed to practice in Ohio, emphasizes primary care, engages in focused research, and embraces both Appalachian and urban communities. Integral to this mission, our college community commits itself to: provide a clinically integrated, learning-centered, osteopathic medical education continuum for students, interns, residents and primary care associates; embrace diversity and public service; and improve the health and well-being of underserved populations.
Vision:
The Heritage College is recognized as the national leader in training osteopathic primary care physicians and the number one producer of primary care physicians in the country.
Essential Values:
These fundamental principles form the foundation of the culture at our college: wholeness and balance within each person; integrity; community of mutual respect; acceptance of others and embracing diversity; pursuit of excellence; a climate of scholarship; and commitment to service, generosity and compassion.
Our Campuses:
https://www.ohio.edu/medicine/about/campuses
Why Choose Ohio University?
https://www.ohio.edu/hr/jobs/working-ohio
https://www.ohio.edu/medicine/community-health
About the Clinical & Translational Research Unit ( CTRU ):
https://www.ohio.edu/medicine/research/ctru
Diversity Statement:
Ohio University is committed to creating a respectful and inclusive educational and workplace environment. Ohio University is an equal access/equal opportunity and affirmative action employer with a strong commitment to building and maintaining a diverse workforce. Women, persons of color, persons with disabilities, and veterans are encouraged to apply.
Special Instructions To Applicant
Please complete the online application and attach required documents. Required documents include a detailed cover letter, current resume, and a list of at least three (3) professional references with current contact details, including email addresses. We seek candidates with a commitment to working effectively with students, faculty and staff from diverse backgrounds.
POSITION SUMMARY :
The Intermittent/ PRN Senior Research Nurse serves as a leader of the research team in all aspects of nursing practice, demonstrating expertise and knowledge in the biomedical research process while ensuring the integrity and quality of clinical research is maintained and conducted at the Heritage College Clinical & Translational Research Unit ( CTRU ).
There are two key duties of the Intermittent/ PRN Senior Research Nurse. The first duty is to independently perform medical tasks or assist with medical procedures performed in the clinical research setting, including highly specialized research techniques and procedures. This involves things like time sensitive sample collections, serial sample collections (e.g., blood draws), drug infusion, conscious sedation, biopsies, and insulin clamping procedures (e.g., setting and maintaining IV lines under time critical conditions). In this regard, the Senior Research Nurse must be prepared to encounter diverse populations with a variety of conditions and first-in-human agents. The Senior Research Nurse must thrive on constantly learning new skills while building on prior knowledge from studies initiated in the past. This position is integral to providing education and training for faculty, students, and other CTRU staff.
The second key duty is being responsible for high level management and coordination of all aspects of conduct of research studies from study start-up activities to close-out. The studies include both sponsored clinical trials (Phases I-IV) and investigator-initiated research studies (qualitative and quantitative) conducted through the Ohio University’s Heritage College of Osteopathic Medicines Clinical & Translational Research Unit ( CTRU ).
PRIMARY ACCOUNTABLES :
Performing Nursing and Medical Research Tasks and Assisting with Medical Research Procedures: Clinical research studies vary widely depending on the protocol, but many require some type of medical task or procedure to be performed. It is expected that the clinical research nurse has 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:
Performing imaging studies with the MRI and DEXA or other specialized equipment
Collecting or assisting with the collection of biological samples (e.g., blood via venipuncture, IV, fingersticks, urine, fecal, tissue)
Processing biological samples in accordance with protocol or study manual
Assesses research subject; completes nursing assessment, documenting findings in research subject records, and notifies appropriate personnel of abnormal findings or results
Assisting in complex and invasive medical procedures including those requiring sterile technique, drug administration, biopsies, insulin clamping procedures, conscious sedation, etc.
Administering drugs (IV, injection, oral, etc.), distribution of investigational drug or intervention and provides patient teaching regarding administration or procedures, as necessary
Performing medical tests (e.g. vital signs, point of care testing, imaging studies, electrocardiograms)
Managing urgent patient care events, for example syncopal events (fainting or passing out)
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
Conduct interviews or focus groups with participants Obtaining authorization for release of medical information as necessary and assuring follow-up care/continuity of care with participant’s personal care provider
Engage study participants at various locations, including but not limited to Heritage College’s campuses, partner hospitals, and in the community.
STUDY MANAGEMENT :
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. Manages operational and daily aspects of research studies. Examples of these duties include but are not limited to:
Submission of protocols and corresponding documents to the Institutional Review Board ( IRB ) for review and approval (i.e. initial, continuing review, deviation, AE/ SAE , close-out, etc.)
May assist PI with research study design and development of the research protocol
May assist with research project budget development
Ensuring site compliance with all research protocols and regulatory requirements
Providing ongoing internal 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 study documents and data tools, including source documents, Qualtrics surveys, REDCap databases, and other study instruments, , etc
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
Maintaining 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
Managing 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
Overseeing and initiating data quality activities including interim monitoring visits and data queries
Management of research record retention schedules upon study completion, notifying PI and/or sponsor of storage location, and assisting with maintaining records via multiple and varying technology methods (i.e., 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
Initiating quality improvement activities and supporting the strategic research mission of the CTRU and Heritage College.
Organizing and leading regular research team meetings and participating in ORG or CTRU team meetings to discuss current activities or planning activities
Attending assigned training and maintaining proficiency with required technologies and procedures
Requires occasional travel to promote CTRU activities or sponsor study training meetings
Providing training or presentations to university, community, or other groups
Training other unit staff on clinical techniques and skills
Minimum Qualifications:
Bachelor’s Degree with BSN or BS with RN certification
8+ years work experience
Valid RN license from the State of Ohio required
Valid Driver’s License required
Valid CPR /First Aid Certification
Preferred Qualifications:
- Master’s Degree
Planning Unit: Heritage College of Osteopathic Medicine
Department: HCOM - Research and Grants
Applicants may contact this person if they have questions about this position: bailey.shooner@ohio.edu
Employment Type: intermittent regular
Advertised Salary:
$36.35-$40.96/hour