Company Name: PPD Development,L.P.

Position Title: Sr. Clinical ResearchAssociate

Location: 929North Front Street, Wilmington, NC 28401

Summary of Duties: Monitorsinvestigator sites with a risk-based monitoring approach, applies root causeanalysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV and CRFreview as applicable through on-site and remote monitoring activities. Assessinvestigational product through physical inventory and records review.Documents observations in reports and letters in a timely manner using approvedbusiness writing standards. Escalates observed deficiencies and issues toclinical management expeditiously and follow all issues through to resolution.May need to maintain regular contact between monitoring visits withinvestigative sites to confirm that the protocol is being followed, thatpreviously identified issues are being resolved and that the data is beingrecorded in a timely manner. Conducts monitoring tasks in accordance with theapproved monitoring plan. Participates in the investigator payment process.Ensures a shared responsibility with other project team members onissues/findings resolution. Investigates and follows-up on findings asapplicable. Provides updates on potential trends noted across multiple sitesand discusses potential strategies for their management to the Clinical TeamManager (CTM). Participates in investigator meetings as necessary. Identifiespotential investigators in collaboration with the client company to ensure theacceptability of qualified investigative sites. Initiates clinical trial sitesaccording to the relevant procedures to ensure compliance with the protocol andregulatory and ICH GCP obligations, making recommendations where warranted.Ensures trial close out and retrieval of trial materials. Ensures that requiredessential documents are complete and in place, according to ICH-GCP andapplicable regulations. Conducts on-site file reviews as per projectspecifications. Contributes to the project team by mentoring new members, assistingin preparation of project publications/tools including informed consents, CRFguidelines and monitoring plans, and sharing ideas/suggestions with teammembers. Assists in project specific training for the clinical team wherenecessary. Identifies areas for potential process improvements and sharepotential solutions for improvements. Duties may be performed remotely. Travelrequired 60%-80%.

Qualifications: Bachelors degree inBiology, Science, Chemistry or related field and Three (3) years of experiencein the job offered or as a Clinical Research Associate II, Clinical ResearchAssociate I, Remote Site Monitor or related role. Must have three (3) years ofexperience with: clinical monitoring; FDA guidelines, ICH GCPs, applicableregulations and procedural documents; risk-based monitoring concepts andprocesses; use of various clinical systems such as EDC and CTMS systems; RootCause analysis, critical thinking and corrective and preventative actionplanning; monitoring visit reporting; and site management and communication,retraining of site staff on protocol as needed.

ToApply: Send resume to: Thermofisherjobs@thermofisher.com. Reference Number:

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