Clinical Research Applications Senior Compliance Manager
University of Virginia

Job Info

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Job location: Charlottesville, VA

Employment Type: Full-time
Posted data: 2021-09-02
Req: R0019365

The Clinical Trials Office (CTO), at the University of Virginia School of Medicine (SOM), is seeking a Clinical Research Applications Senior Compliance Manager.

The Research Applications Senior Compliance Manager provides oversight and compliance management of all clinical research applications managed by the SOM Clinical Trials Office. This position ensures unified integration of the applications, implementation and complete utilization of available functionality of each application, and regulatory compliance of the applications. This position leads the team that supports the applications, resulting in efficient start-up, management, compliance, and reporting of clinical research studies. The Research Applications Senior Compliance Manager will work independently with guidance from Administration.

Clinical Research Applications Senior Compliance Manager Responsibilities Include:

Facilitates policy and workflow development discussions with subject matter experts, administrators and end users.

1. Supervisory Activities:

• Manage the team that provides end-user support, training and education, and continuing development of the research applications managed by the SOM Clinical Trials Office.
• Assign tasks and responsibilities to team members, drives task completion.
• Lead and coordinate project meetings with vendor, team members, stakeholders, subject matter experts, and administration.

2. Application Development and Implementation:

• Lead effort 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.
• Lead the efforts to explore opportunities to leverage applications to add value to clinical trials management. Familiar with basic operations of user groups. Represent study teams' interests in internal workflow development discussions.
• Coordinate and lead project meetings with vendor, team members, stakeholders, subject matter experts, and administration.
• 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.
• Demonstrate 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.
• Lead the team when testing vendor upgrades and proposed workflows to ensure critical systems are supported and identify potential problems that may arise.
• Develop and document the project plan, including timeline, for the implementation of new functionality of existing or new research applications managed by the SOM CTO.
• Identify and work to mitigate risks and roadblocks.
• Track project requirements from initiation to implementation.
• Document progress of the implementation process.
• Communicate updates, decisions, and challenges to project team and stakeholders. Escalate issues that affect deliverables and deadlines to CTO leadership.
• Ensure discussions, decisions and action items from team meetings are documented, communicated and archived.

3. User support

• Lead the team that serves as a primary point of contact for end user support for clinical research applications managed by the SOM Clinical Trials Office.

4. End User Education/Training

• Lead the team that identifies end user educational and training needs.
• Lead the team that develops end user education and training materials, ensuring maintenance to high standards for training, including clinical trials compliance.

5. Policy development and policy compliance

• Identify vulnerabilities and areas for improvement in compliance in the use of the research applications.
• Conduct follow-up with groups, as necessary, to ensure compliance with SOM policies for utilization of the research applications.
• Identify mechanisms to enhance end user compliance with policies and procedures regulating the use of the research applications.
• Facilitate policy and workflow development discussions with subject matter experts, administrators and end users.
• Collaborate with team and CTO leadership to implement policy and procedure changes as they relate to the research applications.

6. Additional responsibilities/duties as assigned

REQUIREMENTS:

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-related field is preferred.

Experience: 8 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.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Demonstrated accountability in project ownership and solution-oriented work approach.
• Experience with identifying and implementing process improvements.
• Accountability in task ownership and solution-oriented work approach.
• Proven organizational skills, attention to detail, with ability to concurrently manage multiple requirements, opportunities and relationships with sometimes competing deadlines.
• 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.

TO APPLY:
EXTERNAL APPLICANTS: please apply through Workday at the following URL, https://uva.wd1.myworkdayjobs.com/UVAJobs , and search for requisition # R0019365. 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 # R0019365. 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 lje5u@virginia.edu .

For more information regarding the application process, please contact Michelle Williams, Faculty Search Advisor, at mew8js@virginia.edu.

COVID Vaccination Requirement

The University of Virginia expects all current and new employees (UVA Health System and Academic), to be vaccinated against COVID-19.

If hired to work within the University Health System, you will be required to provide proof of vaccination or be willing to receive the vaccination. Employees may request a medical or religious exemption from vaccination.

If hired to work on the Academic side of the University, excluding the School of Medicine, School of Nursing, UPG, and the Health Systems Library, you will be required to provide proof of vaccination or be willing to submit to mandatory, weekly prevalence testing. Employees that are working 100% remotely will not be subject to weekly prevalence testing; however, if the employee works on UVA Grounds (including the Medical Center) even intermittently, then they are required to be tested for COVID-19 once per week on an indefinite basis and follow masking mandates.

NOTE: Some medical and safety-sensitive positions require vaccination and are not eligible for an exemption. For more information on how the vaccination and testing requirements will apply to you at your work location, see the UVA New Hire Vaccination Requirements webpage.

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.

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