.Summarized Purpose:Performs and coordinates different aspects of the clinical monitoring and site management process.Essential FunctionsMonitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (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 andCRF review as applicable through on-site and remote monitoring activities.Assess investigational product through physical inventory and records review.Documents observations in reports and letters in a timely manner usingapproved business writing standards. Escalates observed deficiencies and issuesto clinical 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, that previouslyidentified issues are being resolved and that the data is being recorded in atimely manner. Conducts monitoring tasks in accordance with the approvedmonitoring plan. Participates in the investigator payment process. Ensures ashared responsibility with other project team members on issues/findingsresolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. May help to identify potentialinvestigators in collaboration with the client company to ensure the acceptabilityof qualified investigative sites. Initiates clinical trial sites according to therelevant procedures to ensure compliance with the protocol and regulatory andICH GCP obligations, making recommendations where warranted. Performs trialclose out and retrieval of trial materials. Ensures that required essential documents are complete and in place, accordingto ICH-GCP and applicable regulations. Conducts on-site file reviews as perproject specifications. Provides trial status tracking and progress update reports to the team asrequired. Ensures study systems are complete, accurate and updated per agreedstudy conventions (e.G. Clinical Trial Management System). Facilitates effective communication between investigative sites, the clientcompany and internal project teams through written, oral and/or electroniccontacts. Responds to company, client and applicable regulatoryrequirements/audits/inspections. Maintains and completes administrative tasks such as expense reports andtimesheets in a timely manner. Contributes to the project team by assisting in preparation of projectpublications/tools and sharing ideas/suggestions with team members.Contributes to other project work and initiatives for process improvement, asrequired.Qualifications:Education and Experience:Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent andrelevant formal academic / vocational qualification
