Clinical Research QA Specialist - Pulmonary

Cincinnati Children's•Orleans, MA

8d•$56,846 - $72,488•Onsite

About The Position

The Clinical Research QA Specialist - Pulmonary will be responsible for reviewing and analyzing clinical trial data and related documentation. This role provides guidance to clinical faculty and staff on clinical research documentation and clinical trials. The specialist will develop monitoring plans with indicators of quality, reliability, and adherence to SOPs, and develop and communicate outcome measures. A key aspect of this role is developing comprehensive data safety monitoring plans to ensure trials comply with protocols, SOPs, ICH GCP, and regulatory requirements. The specialist will also prepare and execute monitoring plans, conduct site visits, ensure data integrity, verify essential documents, and coordinate follow-up activities. Additionally, this role assists in the development and implementation of action plans for external monitoring/audit follow-up, prepares for and conducts audits/surveys/inspections, and develops improvement plans using quality improvement methods. The specialist will provide input into new protocols and implementation plans, participate in the development of investigator-led protocols, and develop and maintain SOPs for clinical trials. They will serve as a primary resource for clinical trials staff, responding to questions regarding study documentation and GCP. The role also involves assisting in developing and providing clinical trial training and consultation for faculty, staff, and affiliate sites, including training on ICH GCP, FDA, DHHS, state, local, and institutional requirements.

Requirements

Bachelor's degree in a related field
2+ years of work experience in a related job discipline
SoCRA or ACRP certification within 18 months of external hire

Responsibilities

Review and analyze clinical trial data and related documentation (internal and external).
Provide guidance to clinical faculty and staff in clinical research documentation and clinical trials.
Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs.
Develop and communicate outcome measures.
Develop comprehensive data safety monitoring plans for all clinical trial activities within the assigned department to ensure that trials are conducted in compliance with the protocol, SOPs, ICH GCP, federal, state, and local regulatory requirements.
Prepare and execute monitoring plans both internally and at affiliate sites, including site visits to ensure protocol and regulatory compliance; data management tasks to ensure study data integrity; verify essential documents are accurate, complete, and maintained; and coordination of applicable follow-up activities.
Assist in the development and implementation of action plans for external monitoring/audit follow-up.
Assist in preparation and conduct of audits/surveys/inspections by FDA, DHHS, institutional, and accreditation agencies.
Develop improvement plans using quality improvement methods (process improvement, continuous improvement, total quality management, etc.).
Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers.
Participate in the development of investigator-led protocols, e.g., data safety monitoring plans.
Develop and maintain SOPs for clinical trials.
Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested.
Assist in developing and providing clinical trial training and consultation for faculty, staff, and affiliate sites.
Provide training (ICH GCP, FDA, DHHS, state, local, and institutional) and/or other training initiatives to faculty and staff, as assigned.