Job Description:

• Work on research trials that will include multi-centered cooperative group and intergroup trials at a national level, multi-institutional pharmaceutical trials and single and multi-centered trials, designed, implemented, and coordinated in the Section.

• Participate in established and future research programs in the Section.

• Assess, diagnose, and initiate delegated medical treatments, perform independent nursing interventions, and evaluate care for current and prospective research patients.

• Work collaboratively within a multi-disciplinary team, using advanced clinical skills to manage a caseload of research subjects.

• Participate in the conduct of COVID-19 and HIV clinical research projects/studies involving various modalities of treatment for patients in the Department of Medicine.

• Serve as liaison between P.I., sponsoring agent, regulatory groups, patient, family members, referring MD's/community MD's, pharmacist, statistician and other members of the research team.

• Provide assistance with IRB submission.

• Instruct investigator and research staff on submission process and provides instructional materials for reference.

• Work with PI, sponsoring agencies, Medicine Administration, Office of Research Services, and the Clinical Research Support Office to assist with amendment submission, changes or corrections to protocols/and or consent forms.

• Work with Medicine Administration and University Research Administration to submit and revise Clinical Trial Agreements as needed.

• Assist in setting up regulatory documents, shadow file systems, databases, screening logs, adverse experience reporting mechanism, and regulatory binders.

• Train and participate in trial-related activity from the initial entry to complete follow-up of patients enrolled into research protocols including compassionate studies, draw blood specimens, and administer injections.

• Work as a Sub-Investigator under the direction of the PI. These responsibilities include physical examinations, clinical assessments, consenting of subjects, AE/SAE evaluation and interpretation, writing orders for study specific procedures and dosing administration of study drug. Data Collection and Interpretation:

• Evaluate all lab results for signs of toxicity or complications related to either the treatment or disease..

• Report adverse drug reactions and submit the appropriate documentation within 10 working days to the FDA, NCI and IRB.

• Responsible for all follow-up lab tests specified by the study; and additional tests at the discretion of the P.I. to evaluate toxicities and treatment.

• Responsible for educating potential research subjects concerning clinical aspects of their disease, purpose and nature of the protocol, and impact on the patient should they agree to participate (i.e. treatment schema, tests, clinic visits, etc).

• May be required to teach patients and their family members about injections, signs and symptoms of side effects.

• Designs patient education programs that include information required to make informed health care and treatment decisions.

• Develop diagnostic strategies and therapeutic interventions needed to achieve the goals and outcomes of the patientâ™s plan of care.

• Perform other related work as needed.

Preferred Qualifications

Experience:

• Previous experience as an Advanced Practice Provider.

• Two years of clinical experience in infectious diseases.

• Two years of research experience.

Preferred Competencies

• Demonstrated clinical competency, effective leadership and teaching skills.

• Ability to interview and obtain medical information.

• Ability to conduct physical examinations and health assessments.

• Strong interpersonal skills and the ability to work independently.

• Strong organizational skills .

• Demonstrated written and verbal communication skills and strong analytical skills.

• Proficiency in the use of computers.

Application Documents

• Resume (required)

• Cover Letter (required)

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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.

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