Tonya LaClair

Review committee and expedited level review submissions to the Institutional Review Board

(IRB) for completeness as well as general review and assessment of compliance with local requirements, federal regulations, and ethical standards.

Provided expert support to investigators on submission and approval processes' policies and procedures.

Review expedited level and select committee level review submissions to the board for completeness as well as general review and assessment of compliance with local requirements, federal regulations, and ethical standards.

Provide investigators with support regarding policies and procedures during the submission and approval processes.

Maintain expertise in interpretation of federal regulations and guidance to ensure best practices at the local level and aided in modification of local Standard Operating Procedures as required.

Voting IRB member.

Act as a reviewer on behalf of the IRB for exemption.

Provided administrative support to the staff and members of the Committee for the Protection of Human Services (CPHS), to enhance the efficiency of the CPHS operations, and to expedite communications between CPHS staff, members and the research community.

Management of tasks included, but were not limited to: Conflict of Interest, Protocol Deviations, Serious Adverse Events and Proposed Studies, organize and manage print and digital records, correspondence and other files, responsible for the primary data entry to databases and database updates, arranged CPHS education sessions, prepared education materials, maintained the CPHS education database, and provided researchers with education certificates, organized and obtained information for the CPHS meetings, prepared monthly meeting materials for CPHS members, tracked attendance to ensure quorum, generated the meeting agenda and distributed the meeting materials to members prior to the meeting, handled post-meeting tasks, including review and organization of each study file, updated the databases, followed up with communications, management of approved meeting minutes, provided back-up for the IRB Analysts, Assistant Director and Director in all office tasks. Provided assistance with developing a new database system (RAPPORT) for CPHS. Maintained and managed the RAPPORT database for CPHS.

The CPHS office is a service center with a high volume of production and compliance responsibilities with federal regulations. As such, the staff has high expectations for accuracy, efficiency, an responsiveness to the needs of the Dartmouth College and DHMC research community.