• Provide guidance to IRB members, the administrative staff, research sponsors, and investigative sites on regulatory compliance issues pertaining to the conduct of human research. • Monitor new policy or revisions to existing policy, to ensure proper implementation by the Board and/or administrative staff, as designated by the IRB Chairman and Institutional Official.• Evaluate the Training and Education Program for the Board and Staff, Board meetings to ensure compliance with policy and regulations, meeting minutes to ensure that IRB meetings are accurately documented, and Internal file audits to ensure compliance with Sterling IRB policies and procedures and applicable regulations.• Assist in the development of training and education sessions for the administrative staff and Board at the request of the Director of Quality Management & Regulatory Compliance.• Assist prospective/new Board members and new employees in the orientation process.• Attend Sterling IRB meetings for the evaluation of Board activities and to provide regulatory guidance, as needed.• Assist with scheduling, preparing for, facilitating and/or responding to sponsor/CRO, site and for cause audits of research sites.• Assist with the completion and response to vendor questionnaires. • Investigate and resolve subject or regulatory compliance concerns from research subjects, sites, and Sponsors through communication with Sponsors, sites, subjects, and the Board.• Assist in the generation and processing of regulatory correspondence including correspondence for non-compliance, compliance, and unanticipated problems as directed by Institutional Officials, Chairman and the Board.• Assist in maintenance of SOPs, Meeting minutes, IRB Records, Sterling IRB Web Site.• Responsible for other specified duties or projects assigned by the Director of Quality Management & Regulatory Compliance Analyst as needed.

Works with the Operations Department management and/or Quality Management Department on job assignments as assigned on a PRN bases. All job functions are performed remotely.

• Responsible for developing a set of quality standards applicable to client deliverables.• Responsible for establishing a system for quality control review of client deliverables prior to issuance.• Performs quality control reviews of client deliverables prior to issuance in accordance with established system.• Performs cross-training of additional operational staff member(s) to perform quality control reviews.• Responsible for collecting client feedback via Account Management Department and Operations Department regarding deliverables to incorporate into deliverable standards.• Responsible for working with the Operations Department management and/or Quality Management Department to generate corrective actions and/or training when patterns of quality deficiencies in client deliverables are noted.• Managed, supervised, and performed annual job performance evaluations for direct reports.• Acted as the team’s primary point of contact for incoming work requests from the Account Management Department.• Monitored workload of team members and distributed workload among cross-trained team members as needed to ensure responsiveness to the needs of the Account Management Department.• Responsible for overseeing the team’s processing of submissions for Principal Investigator and Site reviews in single and multi-site studies.• Responsible for managing the processing of requests for a change in the Principal Investigator.

• Responsible for overseeing all activities related to the review of changes in approved research.• Primary point of contact for Sponsor and Principal Investigator inquiries.• Managed, supervised, and performed annual job performance evaluations for the administrative staff positions that are direct reports.• Reviewed protocol amendment submissions for completeness and made an initial determination as to whether they will be reviewed by Expedited or Full Board review.• Communicated the determinations and requests of the Primary Reviewer/or the Full Board to Sponsor and/or Principal Investigators.• Generated Expedited/Full Board review approval documents.• Managed the generation of letters of acknowledgment for documents received that do not require approval.• Managed the activities related to the translation of study materials and informed consent documents.• Managed the review process of recruitment and retention materials.• Oversaw the Quality Assurance review of IRB correspondence generated by the Modifications and Amendments Department.• Managed the preparation and manager check of assigned sections of the IRB meeting minutes.

• Responsible for overseeing all activities related to the review of changes in approved research.• Primary point of contact for Sponsor/Principal Investigator inquiries.• Managed, supervised, and performed annual job performance evaluations for the administrative staff positions that are direct reports.• Reviewed protocol amendment submissions for completeness and determined if they will be reviewed by Expedited or Full Board review.• Generated Expedited/Full Board review approval documents.• Assisted with the Quality Assurance review of IRB correspondence generated by the Modifications and Amendments Department prior to issuance to Sponsors and research sites.• Assisted with activities related to the translation of study materials.

• Served as Team Leader for both the Quality Control Department (QCU) and Sample Control Unit (SCU).• Performed yearly performance evaluation for team members, continuous training for teams, team building activities and handled employee personnel issues.• Supervised employees responsible for auditing method validations, bioanalytical studies, pharmacokinetics, reports, and computer validations.• Ensured integrity of studies through instatement and revision of Standard Operating Procedures, Good Laboratory Practices and Business Continuity Disaster Recovery Plan.• Ensured all raw data, correspondence files, reports, equipment records, and other archived materials were archived properly, in a timely manner, and could be easily retrieved.• Implemented electronic system for tracking employee training records and Standard Operating Procedures.• Participated in client and FDA audits to provide answers on archiving, company process, QC procedures or Sample Control procedures.

• Audited and inspected method validations, bioanalytical studies, pharmacokinetic data, reports, training records, and equipment records to ensure compliance with SOPs, protocols and GLP regulations.• Monitored, inspected and audited regulated clinical and non-clinical studies.• Performed inspections of CEDRA’s laboratories, off-site archive facility and vendors.• Maintained active and historical Standard Operating Procedures and Master Schedule.• Ensured that proper in-process inspections were performed on 21CFR Part 58 GLP regulated studies.• Ensured all raw data, correspondence files, reports, equipment records, and other archived materials were archived properly, in a timely manner, and easily retrieved.

• Audited and inspected method validations, bioanalytical studies, pharmacokinetic data, reports, training records, and equipment records to ensure compliance with GLP regulations.• Monitored, inspected and audited regulated clinical and non-clinical studies.• Communicated audit/inspection findings to Project Directors and Management.• Performed inspections of CEDRA’s laboratories/facilities, off-site archive facility and vendors.

• Quality Controlled bioanalytical raw data. • Audited for proper GLP documentation.• Involved in preparing Excel and Access worksheets of raw data.• Generated summary worksheet data into summary tables for reports.• Performed control checks on folders containing raw data, tables and reports.