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Clinical Research Associate II (CRA II)

Laboratory Corporation of America Holdings (Covance)

Manila, Philippines

<h2>Job Overview:</h2><ul><li><p style="margin: 0px;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP</span></p><ul><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Assures the implementation of project plans as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Responsible for all aspects of site management as prescribed in the project plans</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">General On-Site Monitoring Responsibilities:</span><ul><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy</span></li></ul></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Prepare accurate and timely trip reports</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Manage small projects under direction of a Project Manager/Director as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Review progress of projects and initiate appropriate actions to achieve target objectives</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Organize and make presentations at Investigator Meetings</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Participate in the development of protocols and Case Report Forms as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Participate in writing clinical trial reports as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Internet with Internal work groups to evaluate needs, resources and timelines</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Act as contact for clinical trial supplies and other suppliers (vendors) as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Responsible for all aspects of registry management as prescribed in the project plans</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Undertake feasibility work when requested</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Conduct, report and follow-up on Quality Control Visits (CQC) when requested</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Assist with training, mentoring and development of new employees, e.g. co-monitoring</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned</span></li><li style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Perform other duties as assigned by management</span></li></ul></li></ul><h2>Education/Qualifications:</h2><ul style="margin-top: 0cm;"><li><span style="font-family: 'Calibri',sans-serif;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.</span></li><li><span style="font-family: 'Calibri',sans-serif;">Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements</span></li><li><span style="font-family: 'Calibri',sans-serif;">Thorough knowledge of monitoring procedures</span></li><li><span style="font-family: 'Calibri',sans-serif;">Basic understanding of the clinical trial process</span></li></ul><h2>Experience:</h2><ul style="margin-top: 0cm;"><li><span style="font-family: 'Calibri',sans-serif;">A minimum of 2 (Two) years of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted. Prior acute care monitoring experience or relevant prior clinical experience is an advantage.</span></li><li><span style="font-family: 'Calibri',sans-serif;">Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines</span></li><li><span style="font-family: 'Calibri',sans-serif;">Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</span></li><li><span style="font-family: 'Calibri',sans-serif;">Good planning, organization and problem-solving abilities </span></li><li><span style="font-family: 'Calibri',sans-serif;">Ability to work with minimal supervision</span></li><li><span style="font-family: 'Calibri',sans-serif;">Good communication and interpersonal skills</span></li><li><span style="font-family: 'Calibri',sans-serif;">Good analytical and negotiation skills</span></li><li><span style="font-family: 'Calibri',sans-serif;">Computer competency</span></li><li><span style="font-family: 'Calibri',sans-serif;">Fluent in local office language and in English, both written and verbal</span></li><li><span style="font-family: 'Calibri',sans-serif;">Works efficiently and effectively in a matrix environment</span></li></ul>

Job posted: 2021-12-03

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