Job Description

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:

Why Choose Ohio University?

About the Clinical & Translational Research Unit ( CTRU ):

Position Summary:
The 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 Senior Research Nurse. The first duty is to independently perform medical tasks or assist with medical procedures performed in the clinical research setting, including but not limited to 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). 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 Responsibilities:
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 Included 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: Jordyn Stimel, jordyn.stimel@ohio.edu

Employment Type: intermittent regular

Advertised Salary:

The target hiring range is $36.35/hour to $40.96/hour. The final offer will be commensurate with the candidate's education and experience in relation to the minimum qualifications for the position.

About Ohio University

Ohio University is home to one of the nation’s friendliest and most picturesque campuses. But more importantly, it’s where you can become part of a two-century tradition of excellence and embark upon a rewarding career that will make a real difference. From teaching and research to admissions, facilities maintenance, and residence life, our faculty and staff propel Ohio University’s mission of helping students become their best selves. OHIO offers competitive compensation and outstanding benefits. For a complete list of employment opportunities, please visit University is an equal access/equal opportunity affirmative action institution. For more information about Ohio University’s policies prohibiting discrimination and harassment, visit

Connections working at Ohio University

Job Tags

Work experience placement, Interim role, Relief,

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