CRA (LEVEL II)

Cra (Level Ii) - 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. 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. 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 Clinical TeamManager (CTM) as required. Ensures study systems are updated per agreedstudy conventions (e. g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the clientcompany and the PPD project team through written, oral and/or electroniccontactsResponds to company, client and applicable regulatoryrequirements/audits/inspections. Maintains & 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.