Monitors 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 pplicableProvides updates on potential trends noted across multiple sites and discussespotential strategies for their management to the Clinical Team Manager (CTM).Participates in investigator meetings as necessary. Identifies 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. Ensures 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.Contributes to the project team by mentoring new members, assisting inpreparation 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 & share potentialsolutions for improvements.Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CMCRA) ( trip report review, newsletter creation, lead CRA team calls etc).Provides trial status tracking and progress update reports to the Clinical TeamManager (CTM)as required. Ensures study systems are updated per agreedstudy conventions ( Clinical Trial Management System, CTMS). Perform QCcheck of reports generated from CTMS system where required.Facilitates effective communication between investigative sites, the clientcompany and the PPD project team through written, oral and / or electroniccontacts.Responds to company, client and applicable regulatoryrequirements / audits / inspections federal regulatory requirements / audits.Maintains & completes administrative tasks such as expense reports andtimesheets in a timely manner
