Briana S. Email and Phone Number

Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.Responsible for multiple projects and must work both independently and in a team environment.Verifies that the investigator is enrolling only eligible subjects.Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.Provides mentorship, training and direction to Clinical Research Associates when needed.Responsible for the scheduling and conducting of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.Verifies the rights and well-being of trial subjects are protected.

Implemented and monitored clinical trial to ensure investigator obligations are met and are compliant with protocol, FDA and ICH guidelines. Independently prepared and performed Investigator site visits relevant to the phase of the study: (Qualification, initiation, regular monitoring and site closure) as specified in the project plan and the monitoring guidelines.Ensured compliance of the trial conduct with the protocol and the applicable guidelines and regulations (FDA CFR21 / ICH-GCP).Ensured site's source documents were compliant with the ALCOA principles.Write/review patient documents (informed consent, subject information sheet), clinical study protocol, CRF and trial related financial agreements.Reviewed on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current and is documented appropriately.Identified site issues and initiated correction plans based on monitoring reports. Performed investigative site file reconciliation: requested any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH - GCP guidelines, Standard Operating Procedures (SOPs), and sponsor requirements. Verified data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner. Assured timely reporting of protocol violations as well as Adverse Events (AE)/ and or Serious Adverse Events (SAE).Verified drug accountability logs and storage requirements.

Monitored investigator sites (initially under close supervision from CRAs and SrCRAs) to ensure compliance with project SOPs, requiring overnight travel up to 50% of the time.Generated study-specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports.Selected specialists for support in clinical trials.Conducted project feasibility assessments.Resolved queries of CRF data with study site personnel.Obtained, review for appropriateness, and process regulatory and administrative documents from investigator.Prepared investigator sites for sponsor audits and assisting sites with resolution of audit findings.Provided support to Investigators, Study Coordinators and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.Participated when required, in other areas of study management and staff training and contribute to continuous improvement and the review of systems and procedures as appropriate.Established a gauge of monitoring competence to inexperienced/less experienced colleagues.Studied and conducted Drug Accountability at every Interim Monitoring Visit.Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, GCP guidelines, Standard Operating Procedures (SOPs), and CRO requirements.Performed source document verification, retrieved Case Report Forms (CRFs) and performed query resolution in a timely manner and oversaw drug accountability and safety at investigative sites.

Assisted with recruitment and coordination of subjects by obtaining informed consent, determining eligibility, adhering to safety regulations, and resolving compliance issues.Generated study-specific forms and documents on Microsoft Word, dispensing and accounting for investigational products, overseeing sponsor audits, and communicating with sponsor and authorities.Collected and managed data, obtaining medical histories and vital signs, performing phlebotomy, processing and shipping lab samples, recording adverse events, completing case report forms, resolving queries, filing and archiving.Screened patient records, databases and physician referrals to identify prospective candidates for research studies.Followed informed consent processes and maintained records.Gathered, processed and shipped lab specimens.Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.Maintained compliance with protocols covering patient care and clinical trial operation