Susan Perucci Email & Phone Number

San Diego, Ca, Us

New Haven, Connecticut, Us

San Diego, California, Us

• Provides assistance with specific In-house monitoring duties of clinical trial management providing direct support to the Senior Clinical Research Associate/Clinical Research Associate and the senior Clinical Study Manager staff. Assists in planning, implementation and monitoring of clinical trials (Phases I –IV) to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice. • Provides assistance with specified monitoring duties including but not limited to the review and management of metrics associated with CRA and site performance (e.g. Monitoring Visit Report and Follow-up Letter timeline requirements and Protocol Deviation Management)• Assists with the review and tracking of Monitoring Visit Reports with Supervision by the Senior Clinical Research Associate or Clinical Project Manager (Site Selection, Initiation, Interim and Close-0ut)• Assists Senior Clinical Research Associate or Clinical Study Manager with review of the initial Essential Document Packets for IP release• Maintains ACADIA’s CTMS for the study• Manages the Financial Disclosure tracking process• Assists the senior Clinical Study Manager staff with select relevant clinical tasks associated with a clinical trial• Updates and Maintains clinical trackers, reports site/study status to the Clinical Study Team• Maintains and or provides oversight to a Senior Clinical Assistant who manages the CRO with the maintenance of the Clinical Trial Master Files (eTMF), which includes review of received and in-house generated documents for accuracy and completeness. Files documents according to ACADIA defined guidelines and procedures. Responsible for oversight of ACADIA Sr./Clinical Study Assistant deliverables, if this function is outsourced.• Assist with setting up meetings, take meeting updates and distribute meeting minutes.

San Diego, California, Us

 Support Senior Clinical Study Managers with administrative duties in managing clinical trials (Phases I-IV) to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice (GCP) Provide day-to-day departmental/project support activities with primary responsibility for filing and maintaining the Clinical Trial Master File (TMF). Veeva Vault System Admin. Enter site information to CTMS. Report daily enrollment numbers out of Suvoda IRT. Process clinical records and forms; update and maintain clinical trackers; report site/study status to the Clinical Study Team. Review required site documentation to remain current during the conduct of the study. Identify potential compliance gaps as instructed. Complete data entry and maintain clinical study research’s electronic and paper-based filing systems. Ensure all required documentation has been obtained by the Company and is also available in the investigators Site Files. Prepare study and site regulatory binders and miscellaneous study materials. Coordinate the distribution of communications to all sites (e.g. questionnaires, newsletters, mass mailings, etc.). Submit required documentation for completion of a Clinical Study Report (CSR) or inclusion in a regulatory filing. Attend meetings, take meeting notes, and update and distribute meeting minutes.

 Provided project related support and assistance for assigned projects and project teams. Ensured that all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements. Established and maintained all project documentation including all files, records and reports according to the scope of work and SOPs. Assisted with periodic review/audit of files for accuracy and completeness. Coordinated and track all information, communications, documents, materials and supplies for assigned projects. Updated and maintained internal systems, databases, tracking tools, timelines and project plans with project specific information. Identified and escalated discrepancies in project tracking data, timesheet coding, and expense data billing. Prepared and distributed status, tracking and project finance reports, and assisted the project manager(s) with budget allocation and approval of invoices. Prepared presentation materials for meetings (internal/external) and project summary data. Coordinated project team and/or customer meetings including logistics and materials required. Served as primary backup contact for internal project team and for external customers as designated by project manager. Trained and mentored more junior project support staff.

Raleigh, North Carolina, Us

 Ensured that clinical study documentation is in accordance with SOPs, GCP, and ICH guidelines. Performed quality-control review of clinical and regulatory documents. Provided feedback to document submitters for compliance with client-specific requirements / file structure. Verified submission readiness of document formatting per ICH/CA guidelines. Indexed and QC’d documents for electronic and paper Trial Master Files. Worked with Quality Assurance to resolve audit findings where appropriate. Completed assignments in a timely manner.

Raleigh, North Carolina, Us

 Supported study process to ensure adherence to protocol, SOPs, GCP and ICH guidelines, applicable regulatory requirements, and other documentation requirements. Assisted Project Managers and Lead CRAs in preparing the necessary tools to maintain consistency in the study data across all sites and regional monitors as requested.  Reviewed, tracked, and managed study documentation (e.g. eClinical reports, monitoring visits tracker, required Regulatory docs, CRFs, subject enrollment and visit logs) for completeness and accuracy. Tracked and managed the distribution of study drug and clinical supplies as requested. Supported compliance with study timelines. Assisted with the management of vendors and site payments. Assisted in study start-up activities including:o Contacted sites to discuss study specifics.o Tracked sites interest regarding study participation.o Collected and recorded site questionnaire responses.o Compiled and distributed study binders.o Set-up and maintained project files. Supported and interacted with site staff, project team, and Sponsors. Participated in customer and internal teleconferences, drafted and distributed meeting agendas and minutes. Trained team members on Trial Master File and study shared drives.