The IRB Coordinator will serve as the primary contact and initial resource for investigators, faculty, and staff at Campbell University and partner organizations. A firm understanding of human subject research regulations and federal guidance documents is critical. Work is completed in accordance with the approved university processes and procedures that ensure compliance with federal and state regulations and institutional policies relative to human subjects research. The incumbent is a staff member of the Provost’s Office and reports to the Assistant Provost for Administration.
Essential Duties and Responsibilities:
1. The IRB Coordinator shall perform the following primary IRB functions in support of research protocols:
Review new research applications for consistency, completeness, and compliance with Federal and state regulations and institutional guidelines prior to convened IRB review.
Review all complete project submissions, verify review type, recommend assignment of reviewers, and verify exempt status based on university guidelines.
Review Informed Consent Documents (ICDs) for protocol and amendment?specific content and to ensure presence of federally mandated elements of informed consent.
Communicate to Principal Investigators items that require clarification, or documents required for submission, to complete a research application for IRB review.
Write correspondence to Principal Investigators to communicate the decisions of the IRB.
Evaluate reports of unanticipated problems, amendments and continuing review forms, and prepare correspondence for review by the committee.
Report serious non-compliance issues to the IRB chair and/or the Research Integrity Officer of the university.
Monitor the regulatory environment and recommend changes, as needed, to the university and IRB chair.
2. The IRB Coordinator shall perform the following IRB administrative duties in support of Institutional Review Board operations:
Coordinate with the IRB chair to produce the monthly IRB agenda for each meeting and ensure that materials are distributed within established guidelines.
Work with other members of the IRB, attend IRB meetings, record deliberations, and write meeting minutes. Ensure that minutes for each meeting are accurately recorded; finalize minutes for IRB Chair approval.
Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
Assist with training and orientation tasks of new committee members.
3. The IRB Coordinator shall perform the following additional functions, as needed, in support of Institutional Review Board operations:
Attend seminars, workshops, and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations.
Participate in, or present at, research?related educational sessions for faculty and staff of Campbell University.
Work collaboratively with the IRB Chair to facilitate ongoing development, implementation, and maintenance of the human subject’s protection program.
May assist preparing Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes, and other related duties as required.
Knowledge, Skills and Abilities Required:
Minimum of a Bachelor’s degree required.
Must possess excellent written and verbal skills, as well as strong problem solving and decision making skills.
Must have knowledge of, and experience in, the interpretation of Federal and State regulations particularly regarding the protection of human subjects (to include working knowledge of Federal regulations for human research: 21 CFR parts 50, 56, 312, and 812; and 45 CRF 46).
Ability to interpret laws and regulations to ensure overall protection of human participants.
Ability to advise on matters of general research compliance and ethical human participant research practices.
High level of experience and comfort working independently with senior leadership, faculty, staff, students, medical professionals and external agencies in complex organizations.
Proficient with relevant computer programs.
Experience in designing, operating and implementing electronic IRB applications.
Ability to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities.
Must possess discretion and mature judgment as confidential information is routinely encountered.
Salary will commensurate with qualifications and experience. A review of applications will begin immediately and continue until the position is filled.
Campbell University is unable to accept paper or email applications. Visit us online at http://www.campbell.edu/about/employment/ to apply. Applications should include: 1) letter explaining why your experiences and accomplishments make you a viable candidate for this position; 2) a resume / CV; 3) a list of three references (name, title, contact information, and relationship to applicant); and 4) copies of undergraduate, and graduate transcripts (if applicable) for all institutions attended. Unofficial transcripts are acceptable for initial application purposes. If you have any questions, or if you are an individual with a disability and need assistance completing an application for employment contact the Human Resources Department at 910-893-1256 or email email@example.com. Campbell University is an Equal Opportunity Employer.
Please Note: All positions at Campbell University require honesty, integrity and an understanding of the Mission Statement of Campbell University.
Campbell University maintains a continuing policy of nondiscrimination in employment. It is our policy to provide equal opportunity in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations. Accordingly, the University is committed to administering all educational and employment activities without discrimination as to race, color, sex, sexual orientation, gender identity, age, ethnicity or national origin, religion, disability, genetic information, protected veteran status and any other characteristic protected by law, except where appropriate and authorized by law. This policy of nondiscrimination shall include, but not be limited to, the following employment decisions and practices: hiring; upgrading; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Employees and applicants of Campbell University will not be subjected to any form of harassment or discrimination for exercising rights protected by, or because of their participation in, an investigation or compliance review related to Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act, the Americans with Disabilities Act, Executive Order 11246, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, the Veterans Employment Opportunities Act of 1998, or any other federal or state nondiscrimination law, rule, or regulation.
Campbell University also maintains affirmative action programs to implement our equal employment opportunity policy. Employees or applicants who wish to review appropriate portions of these affirmative action programs may schedule an appointment to do so by contacting the Vice President for Business and Treasurer at the Buies Creek campus, during normal business hours.
Celebrating its 130th year, Campbell University is a private university of the liberal arts, sciences, and professions that embraces its Christian heritage, yet sees no conflict between a life of faith and a life of inquiry. Located in the Research Triangle region of North Carolina, the university enrolls more than 6,800 students across five campuses throughout the state and online. More than 100 ...undergraduate, graduate, and professional degree programs are offered within the university's eight schools.
In recent years, Campbell has experienced unprecedented growth. By leveraging the success of its law and pharmacy schools, the university has addressed the shortage of professionals in other critical fields, such as health and medicine. Campbell opened the Jerry M. Wallace School of Osteopathic medicine in 2013 and recently added graduate degree programs in physical therapy, physician assistant, public health, and undergraduate degrees in nursing and engineering.
Fueled by a higher calling, Campbell provides a transformational learning experience that prepares students for servant leadership and equips them with skills and habits to make a difference in the lives of others.