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Job ID: 16308
Location: Raleigh, NC
Facility/Division: UNC REX Healthcare
Status: Full Time
Shift: Day Job
Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve.
Screens and enrolls patients in clinical trials, conducts all patient follow-up requirements, maintains clinical trial regulatory documents. Current trials include cardiac stents and devices, carotid stenting (high and low surgical risk patients), lipid-lowering medications, and anticoagulant medications.
1. Screen patients daily of all current investigators for clinical trial eligibility. Consent and enroll eligible patients.
2. Collect any necessary specimens and prepare shipment to appropriate core laboratory. Collect patient data and/or information from catheterization laboratory, copy patient chart.
3. Complete appropriate case report forms for all patients enrolled.
4. Ship angiography films, ECG's and/or ultrasounds to appropriate core laboratories. Perform drug and/or device accountability.
5. Provide in-service for hospital and cardiac catheterization laboratory staff on currently enrolling protocols. Provide information to Pharmacy regarding all investigational drug protocols. Provide device accountability to cardiac catheterization laboratory procurement and information services department.
6. Attend Investigator and Clinical Research Coordinator meetings for various upcoming protocols. Attend regularly scheduled phone and/or web teleconferences for currently enrolling studies.
7. Maintain regulatory documents for currently enrolling studies. Print and file all sponsor correspondence. Maintain internal databases as needed (carotid artery and left main stenting).
8. Perform office and/or phone follow-up visits.
9. Report serious adverse events and protocol deviations to the appropriate sponsor as required. Prepare data for sponsor and monitor review on a regular basis.
10. Prepare and submit new protocols, protocol amendments, serious adverse events, protocol deviations, sponsor safety reports, and other necessary documents. Accommodate sponsor and/or FDA audits as necessary.
● Associate degree required. Bachelor's degree is preferred.
Professional Experience Requirements:
● Previous experience in clinical or laboratory research field preferred.
Knowledge/Skills/and Abilities Requirements:
● LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. STATISTICAL REPORTING; ANALYZE TRENDS; STATISTICAL ANALYSIS; DATA VERIFICATION; DATA CODING-GENERAL; DATA ANALYSIS/INTERPRETATION. REASONING ABILITY Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Legal Employer: NCHEALTH
Entity: UNC REX Healthcare
Organization Unit: Rex NC HandV Research
Work Type: Full Time
Standard Hours Per Week: 40.00
Work Schedule: Day Job
Location of Job: US:NC:Raleigh
Exempt From Overtime: Exempt: No
The UNC Health System and the UNC School of Medicine are committed to valuing all people throughout our organization, regardless of background, lifestyle, and culture. A diverse and inclusive work environment for staff and culturally appropriate care for our patients, are essential to fulfilling our UNC Health vision of improving the health of all North Carolinians.
UNC Health is an equal opportunity employer. As such, UNC Health offers equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, genetic information, disability, sexual orientation, gender identity or political affiliation.