Position Summary The Compliance Specialist assists Villanova University and its research community in complying with federal regulations and institutional policies by coordinating the daily tasks related to research protocols submitted for Committee review (IRB, IACUC, IBC). Process protocols, responds to inquiries, and conducts all facets of protocol review management to assist the Investigators and the Committees. Assists the Associate Director on other Research Compliance matters as assigned.
Villanova is a Catholic university sponsored by the Augustinian order. Diversity and inclusion have been and will continue to be an integral component of Villanova University's mission. The University is an Equal Opportunity/Affirmative Action employer and seeks candidates who understand, respect and can contribute to the University's mission and values.
Duties and Responsibilities
Processes new protocols, modifications, renewal, and other submissions, and coordinates the review process; determines difficulty level of protocol issues; assists in preparing submitted protocols for Committee action; assigns reviewers; delineates revision requirements; reviews investigators responses; provides action letters to Investigators.
Coordinates Committee meetings; prepares agenda and materials to meet Committee deadlines; works with Associate Director to ensure meeting results are managed and documented appropriately.
Gathers information and background material in response to inquiries; responds to requests for information regarding research compliance matters.
Assists with maintenance and revision of standard operating procedures, forms, and system configuration.
Identifies areas of needed education based on interactions with Investigators and Committees; informs Associate Director of any broader issues observed.
Assists in education initiatives.
Attends workshops or conferences relevant to assigned duties; maintains current regulatory knowledge.
Performs other duties as assigned.
Bachelors Degree required.
Understanding of regulatory review process required. Basic knowledge of federal regulations and their implementation in the higher education setting. Ability to understand policy and procedure in this context.
Attention to detail, decision-making skills, and collaborative attitude required. Excellent written and verbal communication skills; courteous and professional in all communication; ability to maintain discretion and confidentiality in all professional matters.
Fluency in Microsoft Office suite. Ability to master electronic systems and processes required.
3 years experience in a research regulatory environment preferred.
Physical Requirements and/or Unusual Work Hours
Special Message to Applicants Applications must include contact information for 3 references. References will only be contacted for finalists.
Posting Date: 04/12/2017
Closing Date (12am ET):
Open Until Filled:
Salary Posting Information: Salary commensurate with experience.
Villanova is a Catholic university sponsored by the Augustinian order. Diversity and inclusion have been and will continue to be an integral component of Villanova University's mission. The University is an Equal Opportunity/Affirmative Action employer and seeks candidates who understand, respect and can contribute to the University's mission and values. Villanova University is committed to providing leadership in the attainment of equal employment for all individuals. It is the policy and practice of Villanova University to recruit and select applicants on the basis of their qualifications and abilities. This effort is in compliance with all federal and state laws, including Title VI and VII of the Civil Rights Act of 1964, Title IX of the Educational Amendments of 1972, Section 504 of the Rehabilitation Act of 1975, Executive Order 11246, and the Americans with Disabilities Act.
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Villanova was founded in 1842 by the Order of St. Augustine, and to this day, Villanova's Augustinian Catholic tradition is the cornerstone of an academic community where students learn to think critically, act compassionately, and succeed while serving others. Villanova prepares students to become ethical leaders who create positive change everywhere life takes them.
As a Villanova University ...employee you will be part of a dynamic community where each individual and their contributions are valued. Working at Villanova will give you the opportunity to contribute to our mission and values, while working with some of the most experienced educators and staff in the country. We invite you to join the more than 2,500 faculty and staff at Villanova University who have already discovered what Villanova has to offer.
Diversity and inclusion have been and will continue to be an integral component of Villanova University's mission. The University is an Equal Opportunity/ Affirmative Action employer and seeks candidates who understand, respect and can contribute to the University's mission and values.