Liz Domanski Email & Phone Number

Raleigh, Nc, Us

The Clinical Trial Associate (CTA) is a key member of the clinical team and specifically core member of the trial master file (TMF) team is responsible for providing TMF management and support as well as clinical operational support to multiple study teams through all phases of clinical study management, i.e. planning, start-up, conduct and close-out, and archival in accordance with appropriate quality standards including ICH/GCP and the applicable regulations.

Raleigh-Durham, North Carolina Area

• Lead cross-functional efforts toward standardizing processes and maintaining compliance• Developed and implemented a risk-based quality strategy for the TMF• Expert on TMF Periodic Quality Review process and development• Contribute to ongoing process development, review of SOPs and Procedural Documents, and Work Aids to support process improvements• Ensure quality of eTMF in accordance with SOPs which requires daily QC activity and ongoing reviews to ensure compliance and inspection readiness at all times, including confirming that the content collectively provides an accurate reconstruction of the trial• Drafts TMF Management Plan for assigned projects• Performs Study Set Up processes • Performs TMF close out and return process for assigned projects• Assist and participates in internal/external audits• Liaise with study team as they secure Site Essential Documents, confidentiality agreements, master service agreements, clinical trial agreements as appropriate and prioritize sites for IP Release approval• Collaborate with Project Lead and Lead CRA to obtain/share trial specific issues, trends, and risks with a focus on quality, TMF status, completeness by milestone, and inspection readiness metrics throughout life of study• Manage completeness accuracy for multiple studies by maintaining the placeholders for the study, adding events, updating milestones, and managing priority settings where relevant and by providing expert guidance and applying current trends, risks, and needs identified through study team support• Maintain a thorough understanding of the TMF Reference Model and industry trends• Provide support in identification of training gaps and provision of training as needed to improve skillset and core competency• Develop and deliver training and resources on all things eTMF for internal and external users• Triage and escalate system issues to TMF software• Supports system upgrades, change controls, UAT testing on TMF system upgrades

Chapel Hill

Chapel Hill, Nc

• Assist Lead CRAs with investigative site recruitment/feasibility for study-start up, in-house site management activities, as well as study close-out activities in accordance with the Sponsor, protocol, standard operating procedures, ICH/GCP guidelines, and all applicable regulatory requirements• Responsible for both the collection and review of all essential documents from investigative sites as well as TMF maintenance including frequent quality control checks to assess quality and overall health of trial master files (paper and electronic)• Assist investigators and investigative site staff with regulatory submissions, protocol questions, and vendor support• Assist in Program Management for multiple protocols sponsor drug/device programs• Ensure that all site and sponsor interactions are performed and documented in a professional, accurate, and timely manner• Complete Central IRB submissions and support sites through local IRB submissions• Assist with the creation of Informed Consents (ICF), evaluate and review ICFs as well as study material requiring sponsor and IRB approval• Create study templates and plans, as well as Rho internal process documents, and facilitate communication between internal project team and sites as well as sponsor and sites• Mentor and train, as well as developing further guidelines and tools for training new Research Associates Clinical Monitoring Experience:• Assist site CRA on Close-out Visits, documentation and site regulatory binders and other remote monitoring activities• Ensure site compliance with FDA regulations, protocol, GCP/ICH guidelines and sponsor requirements

Chapel Hill, Nc

• Primary contact for 25-60+ sites for multiple protocols. Responsible for distributing project information and materials, answering questions, and ensuring sites have all needed study related materials. • Communicates with sponsor under the direction of Clinical Lead and Project Manager. • DSMB coordinator; Coordinating DSMB activities including scheduling meetings, distribution of meeting materials, drafting meeting minutes.• Responsible for study start up, study maintenance, and study close out, including collect, review, and track regulatory documents.• Responsible for the creation, management and reconciliation of the TMF.• Maintain CTMS, eTMF system, and other tracking tools.• Provided support throughout multiple sponsor TMF audits.• Supports investigators and investigative staff in fulfilling requirements for submission to the IRB (Local and Central).• Assists in the creation and QC of study documents, template, statistical reports, and project displays.• Content administrator for the study website used for sponsor communication.• Writes internal and external correspondence, such as emails, meeting minutes, letters, and reports. • Assists in the review of Informed Consent templates and advertisements.

Chapel Hill, North Carolina

Cary, Nc

The Barter Business Exchange, Inc. (BBE) is the largest bartering network for smart business owners in North Carolina.BBE has been in business since 1994!BBE has a state-of-the art online membership directory that lists the products and services that are being offered by other active BBE barter members that are accepting BBE barter dollars for payment.Currently BBE has over 850 ACTIVE business listings on the online Barter Business Exchange Marketplace Directory.Once you are a BBE member, you can also spend your BBE barter dollars locally, nationally and globally with hundreds of established, reputable barter exchanges that belong to the National Association of Trade Exchanges www.natebarter.com & the International Reciprocal Trade Association www.irta.com.

Raleigh, Nc

Processed & verified provisional ballots for 2012 General ElectionConducted and certified voting re-count under extreme deadlinesCollected data for election resultsProvided telephone support for voters registered in North CarolinaPerformed administrative tasks as assigned to include data entry & related reports

Cary, North Carolina

Developed and implemented Cardiac Maintenance Program for ResidentsDeveloped and implemented Employee Health Risk Assessment ProgramConducted fitness classes for Elderly ResidentsCreated newsletters for Residents & EmployeesWorked closely with director overseeing wellness & fitness programsMentored student volunteers