Reporting to the Director of Operations, the Accreditation Specialist is responsible for providing ongoing coordination, support, monitoring, education, evaluation, and consultation to clients in achieving and maintaining AAHRPP accreditation. The position requires working collaboratively with all AAHRPP staff to ensure continued support of the organization and its clients.
1. Coordinates Step 1 review process by working with reviewers, quality checking reviews and answering questions posed by reviewers.
2. Faciliates interaction between clients and reviewers.
3. Facilites communication between site visit team and AAHRPP during and after site visits.
4. Assists clients in responding to reports.
5. Works with Director of Operations to support the Council on Accreditation.
6. Trains site visitors and staff on the accreditation standards and the regulatory and ethical foundation of the accreditation standards.
7. Maintains a working knowledge of significant developments and trends in the field of human research protections. Analyzes proposed regulations and guidance and prepares reports, when needed.
- Previous experience interacting with AAHRPP or preparing accreditation application(s) to AAHRPP, senior regulatory affairs management at pharmaceutical and medical device companies, or compliance staff at FDA and OHRP.
- Demonstrated success in leading and working collaboratively to motivate people.
- Knowledge of FDA regulations, HHS regulations, and ICH (E6) guideline, and AAHRPP Accreditation Standards.
- Excellent oral and written communication skills.
- Proficiency with MS Office Suite. Knowledge of SharePoint and CRM preferred.
- Bachelor degree required; master degree preferable.
- Strong commitment to quality
- Strong attention to detail
- Strong client service and communication skills
- Team player and ability to work effectively with staff and with management