Liam Long Email & Phone Number

Morrisville, Nc, Us

Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan• Monitors with knowledge of quality/scope/timeline and budget parameters• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates • Maintains project tracking system of subjects and site information, as applicable • Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts • Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager • Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients • Reviews IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan • Completes all required internal training (general and study-specific) on-time • Acts as a resource for other CRAs and shares knowledge base and best practices• Other activities as designated

Morrisville, Nc, Us

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan• Monitors with knowledge of quality/scope/timeline and budget parameters• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates • Maintains project tracking system of subjects and site information, as applicable • Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts • Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager • Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients • Reviews IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan • Completes all required internal training (general and study-specific) on-time • Acts as a resource for other CRAs and shares knowledge base and best practices• Other activities as designated

Durham, North Carolina, Us

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Build awareness of features and opportunities of study to site.• Collaborate and liaise with study team members for project execution support as appropriate.

Princeton, New Jersey, Us

-Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned-Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study-Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements-Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review-Monitor data for missing or implausible data-Ensure audit readiness at the site level-Travel, including air travel, may be required and is an essential function of the job.-Prepare accurate and timely trip reports-Interact with internal work groups to evaluate needs, resources and timelines-Act as contact for clinical trial supplies and other suppliers (vendors) as assigned-Responsible for all aspects of registry management as prescribed in the project plans-Undertake feasibility work when requestedparticipate in and follow-up on Quality Control Visits (QC) when requested-Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned-Assist Senior CRA with managing investigator site budgets-Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs-Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management-Assist with training, mentoring and development of new employees, e.g. co-monitoring

Princeton, New Jersey, Us

Act as contact for project team and study sitesPerform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by managementAssist with generation and reconciliation of queries to investigative sites/clients to resolve problem dataAssist with the management of study supplies and organize shipmentsCreate, update, track, and maintain study-specific trial management files, tools, and systemsAssist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)Coordinate meetings with clients, investigators, and project team, including taking minutesEnsure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily workProvide input in writing Monitoring Conventions as assignedAssist in submissions and notifications to Ethics Committees and Regulatory AuthoritiesGeneral On-Site Monitoring Responsibilities:o Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)o Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Senior Clinical Research Associates, Project Managers or Project DirectorsPerform other duties as assigned by management

Princeton, New Jersey, Us

As a Project Coordinator I helped manage the training of team members, organize meetings, process invoices for payment, and oversee documentation processes. I also handled administrative tasks such as taking meeting minutes, managing distribution lists and maintaining each study's database of contact information for site staff. In this position I learned to manage a sometimes hectic schedule and maintain customer satisfaction by staying highly organized, always communicating clearly with my team members, and quickly prioritizing tasks.

Dallas, Texas, Us

During my time as a server at the Crescent Club I mastered the ins and outs of customer service. I learned the importance of always greeting customers by name, remembering lots of fine details, and juggling competing demands on my time. I also helped coordinate events at the venue, provided technical support to clients running meetings in the club, and helped direct team members to complete group tasks as quickly and efficiently as possible.

Louisville, Ky, Us

As an apprentice at The Software Guild I've learned the fundamentals of Java including n-Tiered design, unit testing, exception handling, interfaces, and object-oriented programming. I've also learned the fundamentals of web development using HTML, CSS, JavaScript, jQuery, and Spring MVC. I've used mySQL and Spring JDBC to integrate databases into my applications. In addition to these languages and technologies, I've learned to coordinate on group projects using Git, JIRA, sitemaps, wireframes, and agile development methodologies.

I picked up orders at restaurants, reviewed the orders for accuracy, delivered them to customers, and processed their payments. I learned to pay attention to detail, as small mistakes could upset customers. I also learned to be generally courteous and patient with restaurant employees and customers.

Levallois-Perret, France, Fr

I scanned, processed, and relocated inventory, operated electric pallet jacks, and maintained a clean workspace for inspections. I learned how to improve the efficiency of processes and work well with a team.

Bachelor'S Degree, Political Science, Music

Education record