The Department of Pediatrics at the University of Virginia’s School of Medicine is seeking applicants for a Regulatory Coordinator. The coordinator will work directly with clinical research teams to ensure compliance in preparing, processing, submitting, and maintaining regulatory documents required for clinical protocols. The UVA Department of Pediatrics and the UVA Children’s Hospital share a common goal to enhance the health and well-being of children and families through collaborative medica... more details
The Department of Pediatrics at the University of Virginia’s School of Medicine is seeking applicants for a Regulatory Coordinator. The coordinator will work directly with clinical research teams to ensure compliance in preparing, processing, submitting, and maintaining regulatory documents required for clinical protocols.
The UVA Department of Pediatrics and the UVA Children’s Hospital share a common goal to enhance the health and well-being of children and families through collaborative medical care, education of professionals dedicated to pediatric healthcare, breakthrough research that improves lives, leadership, and community service. For more information on the mission, please visit: https://med.virginia.edu/pediatrics/.
Job Responsibilities:
- Assist with IRB applications and annual IRB reporting (both local and central IRBs).
- Assist with research budget development and invoicing management for multiple research projects.
- Assist with research management including research binders and developing source documentation.
- Assist with data management and research feasibility reports in EPIC and REDCap.
- Ensure completion of deliverables and adherence to timelines, track milestones and timelines across projects.
- Assist with initial data reporting and analysis.
- Assist with writing standard operating procedures and other technical documents.
- Work with outside monitors and sponsors in maintaining research materials and licensure in partner-funded research projects.
- Assist with the development of relevant project IRB submissions and manuals of operation, including submission to IRB and PIs for approval.
- Assist with lab work and lab shipments (IATA trained, can be done once hired), including data management in electronic data record systems.
- Assist in routine office management tasks; including ordering research supplies and preparing research shipments and organizing research materials in the office space.
- Assist with scheduling lab activities including interfacing with Clinical Research Unit and Clinical Trials Office.
- Work directly with PI and other supervisory staff to help support routine and non-routine research activities.
- In addition to the above job responsibilities, other duties may be assigned.
Minimum Qualifications:
Education: Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.
Experience: At least two years of relevant experience.
Preferred Qualifications:
- Clinical Research experience
- Knowledge FDA regulations as they relate to clinical research
- Knowledge of HIPPA and other relevant clinical research regulations
- Research certification such as CCRA, CCRC or CCRP
This position will remain open until filled. This is a restricted position and is dependent upon project need, availability of funding and performance. This is Exempt level, benefited position and will not sponsor applicants for work visas. For more information on the benefits at UVA, visit hr.virginia.edu/benefits.
This position is located in Charlottesville, VA.
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 Careers at UVA, and search for R0062451. Internal applicants must apply through their UVA Workday profile by searching ‘Find Jobs’ or through their “Jobs Hub’. Applicants must complete an application online with the following documents:
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 Karon Harrington, Academic Recruiter at fak3ph@virginia.edu.
For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.
Physical Demands:
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.
The University of Virginia, including 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, pregnancy, sexual orientation, veteran or military status, and family medical or genetic information.
