JOB SUMMARY

A Senior Clinical Research Nurse is a member of the research team who serves participants in clinical trials with direct patient care. The essential job functions of this position requires the performance of research-related procedures and support, and establish working relationships with the providers, investigators, and research team members. This position is also responsible for high-quality care and assessments of patients participating in clinical trials for assigned studies.

RESPONSIBILITIES

• Provide training and/or orientation to new investigators, nursing staff, and research team members on research expectations and study-specific topics and requirements, as requested. 
• Maintain a culture of compliance and productivity, inclusive of adherence to training and licensure requirements, as requested.
• Collaborates with site physicians to assist in the integration of clinical research and clinical care.
• Collaborates with and/or directs research team members to ensure research studies are integrated with clinical workflows at the Site, as necessary.
• Design and develop strategies for outreach to patients and physicians, as appropriate to meet or exceed performance expectations.
• Perform and adhere to clinical functions commensurate with pertinent nursing license scope of practice (i.e., keep within state Board of Nursing scope of practice for license as an LPN, RN, etc.)
• Maintain compliance with required hospital and unit-specific training competencies as well as an active nursing license status with the state Board of Nursing
• Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow-up, collect patient/ research participant history, collect, and maintain source documentation, perform data entry, and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events.
• Under the supervision of an investigator, conduct health assessments as medically necessary or required per protocol to assess or resolve adverse events, safety, and general health of study participants.
• Monitor study participants for adverse events and report any adverse events to the principal investigator, and study coordinator, if applicable.
• Administer study interventions and treatments as directed by the principal investigator, if appropriate for scope of license.
• Prepare and monitor administration, usage, and documentation of investigational products and other required treatments in clinical trials.
• Perform diagnostic tests and monitor participants’ health through regular assessments.
• Observe, document, and report any changes in participant’s health status, and provide clinical care where necessary.
• Respond to emergencies and provide medical care as necessary and/or directed by a study investigator.
• Maintain frequent communication with research staff regarding enrollment and tasks.
• Assist with and/or perform the informed consent process of research subjects, if appropriate for scope of license.
• Support and advocate for the safety of research subjects.
• Collect, process, and ship laboratory specimens.
• Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines.
• Performs additional duties as assigned.

WORKING CONDITIONS

This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting.  Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination.  Requires standing and walking for extensive periods of time.  Occasionally lifts and carries items weighing up to 50 pounds.  Requires corrected vision and hearing to normal range. 

Due to the nature of this position, employees are expected to work in person.  This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary.  Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.