Location: Pittsburgh,PA, USA
Supports clinical research projects by facilitating finalization on medical research protocols, managing final approvals of procedures, and assisting research faculty with future trials by study protocol drug and device advisement. Prepares, writes, and presents updated protocols. Works directly with patients and takes medical histories, performs exams, obtains biological specimens, assists with procedures, schedules tests, and performs study-specific protocols. Acts as liaison to regulatory bodies and reports to auditing bodies. Ensures regulatory adherence.
Essential Functions* Oversees review and finalization of all medical research protocols. Manages final approvals of procedural testing, imaging, and physical exams. * Advises research faculty on study protocol drug and devise use. Assists research faculty in setting up future study trials. * Collaborates across departments and with funding agencies in study protocol coordination. * Assists in protocol development and implementation; serves as a resource for coordinators at other sites. Writes and presents protocols, revisions, and amendments for department and regulatory committees/bodies. * Takes medical histories, screens patients, performs physical exams, obtains biological specimens, and assists with procedures. Obtains consent to participate, schedules, and coordinates tests. Performs study protocols including, but not limited to, administering oral study drugs, collecting blood samples, and ensuring appropriate test data is collected. Follows study patients and fosters effective relationships to limit losses. * Educates the parent and/or participant regarding study product, medication, protocol procedures, treatments, and illness prevention. Triages parent telephone calls and provides consultation. * Acts as liaison to federal and regulatory bodies; reports to auditing bodies. * Ensures all protocol and regulatory standards are adhered to.
Physical EffortTravel is required. Moderate physical effort is required. May be required to stand/move for several hours at a time. May be required to move objects up to 50 pounds with or without the assistance of equipment.
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The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
Assignment Category: Full-time regular Job Classification: Staff.Clinical Research Nurse Practitioner Job Family: Research Job Sub Family: Clinical Research - Nursing Campus: Pittsburgh Minimum Education Level Required: Bachelor's Degree Minimum Years of Experience Required: No experience required Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement. Work Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m., may vary depending on recruitments Work Arrangement: Monday - Friday, 8:30 a.m. - 5:00 p.m., may vary depending on recruitments Hiring Range: $64,875.96-$97,314 Relocation_Offered: Yes Visa Sponsorship Provided: Yes Background Check: For position finalists, employment with the University will require successful completion of a background check Child Protection Clearances: Not Applicable Required Documents: Resume Optional Documents: Not ApplicablePlease see job descriptionPI256854508