Clinical Research Associate
Thermo Fisher Scientific

Job Description

Company Name: PPD Development, L.P.

Position Title: Clinical Research Associate

Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties: Monitor investigator sites with a risk-based monitoring approach: apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Document observations in reports and letters in a timely manner using approved business writing standards. Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conduct monitoring tasks in accordance with the approved monitoring plan. Participate in the investigator payment process. Ensure a shared responsibility with other project team members on issues/findings resolution. Investigate and follow-up on findings as applicable. Participate in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Perform trial close out and retrieval of trial materials. Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conduct on-site file reviews as per project specifications. Provide trial status tracking and progress update reports to the team as required. Ensure study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitate effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Respond to company, client and applicable regulatory requirements/audits/inspections. Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner. Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contribute to other project work and initiatives for process improvement, as required. Duties may be performed remotely. 85-90% domestic travel required.

Qualifications: Bachelor's degree in Science, Business, Pharmaceutical Science, or related field and one (1) year of experience as Assistant Clinical Research Associate, Site Activation Coordinator, Clinical Data Assistant or related role. Must have one year of experience with: GCP/FDA regulations; Clinical Trials processes: data entry of regulatory documents and maintenance of Investigator information in the Clinical Trial Management System and evaluating the investigator and site staff for qualification and training to confirm adequacy and provide study-specific training as required throughout the trial; Navigating multiple company and vendor systems; Determining IT issues and escalate to resolution through appropriate channels; Adjusting to connectivity: wireless strength signal, Wi-Fi signal issues (areas that are spotty), connecting the laptop to a Wi-Fi source; Clinical Systems: including but not limited to IXRS, EDC, eTMF, CTMS, etc.; Managing sites and studies assigned; Site Management: Subject recruitment, conducting onsite monitoring, and conducting Site Management Calls; Data Administration: Entering data into appropriate systems in real time, using appropriate guidelines to ensure data consistency, and data querying across study systems and platforms; and Data and Metrics Analysis: using available systems, dashboards, data and information that is provided for projects to identify inconsistencies and assessing for root cause and manage an action plan with site for improvement.

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