Research Applications Compliance Analyst
Job location: Charlottesville, VA
Employment Type: Full-time
Posted data: 2020-12-02
The Clinical Trials Office (CTO), at the University of Virginia School of Medicine (SOM), is seeking a Clinical Research Applications Compliance Analyst.
The Research Applications Compliance Analyst will provide end user support, training, development and direction for the clinical research applications managed and supported by the SOM Clinical Trials Office, such as OnCore and CRConnect. The successful applicant will work with end users to provide general subject matter expertise in the use of all SOM CTO managed research applications that are used to support clinical research. The incumbent is also be responsible for assisting end users in achieving compliance with UVA SOM policies and procedures governing the use of the research applications. The incumbent will work independently, but under supervision.
Clinical Research Applications Compliance Analyst Responsibilities Include:
1. User support:
- Serve as a primary point of contact for end user support for clinical research applications managed by the SOM Clinical Trials Office applications. Work with end users to provide general subject matter expertise in the use of multiple applications in management of clinical trials.
- Apply knowledge of the OnCore, CRConnect, and other clinical trials management applications to provide assistance in daily operations to end users. Troubleshoot problems and explain policy.
- Work closely with study teams to support clinical trials efforts.
2. End User Education/Training:
- Maintain current standards for training, including clinical trials compliance.
- Identify end user educational needs.
- Develop training materials for research applications.
- Train end users in the use of the research applications.
3. Outside user access:
- Assist users at other institutions in navigating access to UVA clinical research applications managed by the SOM CTO.
4. Application development:
- Collaborate on efforts to develop/improve clinical trial applications workflows.
- Maintain a working knowledge of how the CTO managed applications impact and are impacted by other UVA systems, e.g. Protocol Builder, IRB On-Line, Research UVA.
- Explore opportunities to leverage applications to add value to clinical trials management. Is familiar with basic operations of user groups. Represent study teams’ interests in internal workflow development discussions.
- Evaluate user requests to determine need and feasibility. Collaborate with study teams, administration, technical support and application vendors, when necessary, to research, identify and implement solutions/options.
- Take opportunities to increase knowledge of current regulatory requirements, as needed. Continuously learn about emerging in-house and nation-wide electronic systems that may be utilized in clinical trials management.
- Participate in testing vendor upgrades and proposed workflows to ensure critical systems are supported and identify potential problems that may arise.
5. Policy development and policy compliance:
- Collaborate on efforts to develop/improve clinical trials applications standard operating procedures that support the systems.
- Identify mechanisms to enhance end user compliance with policies and procedures regulating the use of the research applications.
6. Additional responsibilities/duties as assigned:
Education: A Bachelor's Degree in a relevant discipline is required. Significant relevant experience may be considered in lieu of a degree. Bachelor's Degree in a science or computer science-related field is preferred.
Experience: 2 years of experience working in or with clinical trials, clinical research management/administration, and/or IRBs required. Additional experience may be required in lieu of Bachelor’s Degree. Prefer 3-5 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate, or 3-5 years working in system development or support.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
- Accountability in task ownership and solution-oriented work approach.
- Highly organized with ability to concurrently manage multiple requirements, opportunities and relationships with sometimes competing deadlines.
- Must be able to work independently.
- Knowledgeable in the use of information technology, familiarity with fundamentals of web-based application support (navigation, user administration, data reports).
- Experience identifying and implementing process improvements.
- Excellent verbal and written communication skills, proficient use of desktop tools such as Outlook, Excel, Visio, etc.
- Prefer working knowledge of state and federal guidelines as they apply to the conduct of clinical research.
- Prefer knowledge of GCPs governing clinical research.
- Prefer experience with the following computer applications: OnCore, other clinical trial management system, electronic data capture system.
This is a restricted position; continuation is dependent on funding and satisfactory performance.
Priority review of applications will begin on December 12, 2020, but the position will remain open until filled.
EXTERNAL APPLICANTS: please apply through Workday at the following URL, https://uva.wd1.myworkdayjobs.com/UVAJobs , and search for requisition # R0019366. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address). The successful candidate will pass a criminal background check. Please note that multiple documents can be uploaded in the box.
INTERNAL UVA APPLICANTS: please apply through your Workday Home page, search “Find Jobs”, and search for requisition # R0019366. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address). The successful candidate will pass a criminal background check. Please note that multiple documents can be uploaded in the box.
For more information regarding this position, please contact Lori Elder, Director, SOM Clinical Trials Office, at firstname.lastname@example.org.
For more information regarding the application process, please contact Michelle Williams, Faculty Search Advisor at email@example.com.
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 (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.