Clinical Research Coordinator 1, Department Of Pediatrics Cystic Fibrosis Program

The Department of Pediatrics Cystic Fibrosis Program at the University of Virginia (UVA) School of Medicine is seeking an additional Clinical Research Coordinator. Our clinical research program conducts studies involving both pediatric and adult CF patients. Our site is a member of the CF Foundation's Therapeutics Development Network, and we participate in both observational and treatment/drug studies.

The CRC will work under the direct supervision of a Principal Investigator and experienced CRC. The successful candidate will be responsible for coordinating all aspects of clinical research from study start-up through archiving of study records, in collaboration with our existing research staff. The successful candidate will be required to manage multiple clinical trials simultaneously in accordance with current regulatory requirements and maintain study documentation in a manner that is "audit ready." The successful candidate must also possess excellent interpersonal skills, organizational skills and the ability to clearly articulate information to clinicians and other members of the research team.

The successful candidate will be expected to:

• Work closely with an experienced CRC and Principal Investigator to learn the full scope of clinical research duties.

• With the mentorship of a CRC and/or PI, learn how to read and follow a clinical trial protocol as it is written.

• Demonstrate a clear understanding of the importance of patient safety in clinical research and identify the components of a clinical trial protocol that are employed to protect patient safety.

• Engage in the following study conduct activities: screen and identify eligible patients, obtain and document informed consent, enroll subjects in a study.

• Manage ongoing study conduct activities such as: coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.

• Perform or be trained to perform specific study assessments relevant to CF research studies such as lung function testing and sweat testing

• Collect and enter study data in a timely fashion, maintain corresponding documentation.

• Collect, process, store and ship study specimens as needed.

• Assist in preparation and maintenance of existing study documentation such as: study visit schedules, study drug diaries, monitoring and or training logs, equipment records or study communications.

• Prepare and submit basic regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, and minor protocol modifications.

• Become familiar with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.

• Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.

• In addition to the above job responsibilities, other duties may be assigned.

• To be promoted, a CRC 1 must demonstrate a basic understanding of clinical research processes and regulations (federal and local) that govern the conduct of clinical research.

Minimum Requirements:

• Bachelor's Degree Required or equivalent combination of experience, education and or certifications.

• Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

This position is a restricted position and is dependent upon project need, availability of funding and performance. This is a Non-Exempt level, benefited position. For more information on the benefits at UVA, visit hr.virginia.edu/benefits .

This position will remain open until filled. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.

References will be completed via UVA's standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process.

To Apply:

Please apply through Workday , and search forR0050383.

Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. Complete an application online with the following documents:

• CV

• Cover letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

For questions about the application process, please contact Yelena Markazyan, Academic Recruiter at ym3mm @virginia.edu

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.

The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.