Job description
The primary purpose of this position is to support the overall administration of the human research review and approval process, providing high-level support and guidance to investigators and other stakeholders, and streamlining IRB processes. Through these activities, this position helps ensure that the University’s human research activities are in compliance with institutional SOPs and international, federal, state, and local rules and regulations, and the ethical principles regarding the involvement of humans in research to protect their safety, rights, and welfare.
The IRB Analyst will be responsible for screening and processing human research applications in accordance with human research related regulations, rules, and policies. This position will provide assistance to all customers and will analyze and interpret complex regulations, rules, and guidance related to human research in order to serve as a process expert. The IRB Analyst will effectively communicate, both written and verbally, and serve as a dependable resource for a wide variety of customers. This position will also understand and support the technology required for conducting daily business. This position requires interpretation of federal regulations and guidance and evaluating human research applications received by the UMCIRB. Necessary skills to carry out these job responsibilities include critical thinking and analytical skills, and sound judgement. The position will work closely with other staff, investigators with varying levels of experience, and administrative leaders to support the human research enterprise. There will be remote work flexibility after a period of training. Once the person filling this position has met the required years of experience, they will be expected to pass the Certified IRB Professional (CIP) examination.
The IRB Analyst will be responsible for screening and processing human research applications in accordance with human research related regulations, rules, and policies. This position will provide assistance to all customers and will analyze and interpret complex regulations, rules, and guidance related to human research in order to serve as a process expert. The IRB Analyst will effectively communicate, both written and verbally, and serve as a dependable resource for a wide variety of customers. This position will also understand and support the technology required for conducting daily business. This position requires interpretation of federal regulations and guidance and evaluating human research applications received by the UMCIRB. Necessary skills to carry out these job responsibilities include critical thinking and analytical skills, and sound judgement. The position will work closely with other staff, investigators with varying levels of experience, and administrative leaders to support the human research enterprise. There will be remote work flexibility after a period of training. Once the person filling this position has met the required years of experience, they will be expected to pass the Certified IRB Professional (CIP) examination.
Minimum Education/Experience
Bachelor’s degree and one year of experience related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
License or Certification required by statute or regulation
None
Preferred Experience, Skills, Training/Education
Master’s degree in clinical research, health-related or biomedical field; Certification as an IRB Professional (CIP); Clinical Research Professional (CCRP); or Clinical Research Associate (CRA) or eligibility to apply for certification. Knowledge of biomedical research, social and behavioral research, data security and confidentiality, multi-site and collaborative research. Ability to work with people of diverse backgrounds. General knowledge of Good Clinical Practice (GCP), ICH, FDA, OHRP, federal regulations related to human subjects’ research as well as the ethical principles in the Belmont Report. Ability to work with diplomacy and tact while working with high level faculty members and staff. Strong verbal and written communication skills and good customer service skills. Ability to multi-task and prioritize work assignments.
License or Certification required by the Department
None
Special Instructions to Applicant
- Please ensure your full range of knowledge, skills, abilities, experience and education are listed on your application. Do not write ‘see resume’ on your application when completing the job duties section.
- If you answer the questions at the end of the application, please ensure your application reflects the knowledge, skills, abilities and experiences to support your answers (see job duties section of previous employment).
- Failure to answer the questions at the end of the application will not preclude your application from being considered but may result in your application not receiving full consideration of your knowledge, skills, and abilities.
- Applicants must be currently authorized to work in the United States on a full-time basis.
Job Open Date
12/05/2022
Job Close Date - Positions will be posted until 11:59 p.m. EST on this date; If no closing date is indicated, the position will be posted until filled and may close at any time after the recruitment has been completed.
12/16/2022
Open Until Filled
No
Quick Link for Direct Access to Posting
https://ecu.peopleadmin.com/postings/56252
Alternate option
If no applicants apply who meet the required competency level and training & experience requirements, then management may consider other applicants. Salary would be determined based on competencies, equity, budget, and market considerations.
AA/EOE
East Carolina University is an equal opportunity and affirmative action employer and seeks to create an environment that fosters the recruitment and retention of a more diverse student body, faculty, staff and administration. We encourage qualified applicants from women, minorities, veterans, individuals with a disability, and historically underrepresented groups. All qualified applicants will receive consideration for employment without regard to their race/ethnicity, color, genetic information, national origin, religion, sex, sexual orientation, gender identity, age, disability, political affiliation, or veteran status.
Individuals requesting accommodation under the Americans with Disabilities Act Amendments Act (ADAAA) should contact the Department of Human Resources at (252) 737-1018 (Voice/TTY) or ADA -Coordinator@ecu.edu.
Individuals requesting accommodation under the Americans with Disabilities Act Amendments Act (ADAAA) should contact the Department of Human Resources at (252) 737-1018 (Voice/TTY) or ADA -Coordinator@ecu.edu.
Eligibility for Employment
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. ECU participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. If highest degree earned is from an institution outside of the U.S. and its territories, final candidates are required to have their degree validated as equivalent to the degree conferred by a regionally accredited college or university in the U.S.
Office of Human Resources Contact Information
If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (252) 328-9847 or toll free at 1-866-489-1740 or send an email to employment@ecu.edu. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.
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