Clinical Research Associate II, FSP - USA-Remote

<h2>Job Overview:</h2><p style="margin: 0px;"><strong>Clinical Research Associate II - </strong><strong>USA Remote</strong></p><p style="margin: 0px;"><strong>Non-Oncology</strong></p><p style="margin: 0px;"> </p><p style="margin: 0px;">Labcorp Drug Development is seeking a CRA to be r<span style="font-family: Calibri, sans-serif; font-size: 12pt;">esponsible 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 and to be r</span><span style="font-family: Calibri, sans-serif; font-size: 12pt;">esponsible for all aspects of site management as prescribed in the project plans.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">General On-Site Monitoring Responsibilities:</span></p><ul><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">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><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">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><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Monitor data for missing or implausible data</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">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 travel policy</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Ensure audit readiness at the site level</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Travel, including air travel, may be required and is an essential function of the </span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Prepare accurate and timely trip reports</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Interact with internal work groups to evaluate needs, resources and timelines</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Act as contact for clinical trial supplies and other suppliers (vendors) as assigned</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Responsible for all aspects of registry management as prescribed in the project plans</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Undertake feasibility work when requested</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Participate in and follow-up on Quality Control Visits (QC) when requested</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">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><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Assist Senior CRA with managing investigator site budgets</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">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><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Assist with training, mentoring and development of new employees, g. co-monitoring</span></li><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Coordinate 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><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Perform other duties as assigned by management</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"><strong><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;">Minimum</span><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif;"> Required:</span></strong></p><ul><li><span style="font-size: 12pt; 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)</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Basic knowledge of Regulatory Guidelines </span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Basic understanding of the clinical trial process</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Fluent in local office language and in English, both written and verbal</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Covid 19 Vaccination Required</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"><strong>Preferred:</strong></span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Working knowledge of SOPs regarding site monitoring</span></li></ul><h2>Experience:</h2><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of at least 9 months of Onsite Clinical Monitoring experience and 2 years total in clinical research experience is required. </span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Thorough knowledge of monitoring procedures </span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Basic understanding of the drug accountability process</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Valid Driver's License</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, 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 style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good planning, organization and problem-solving abilities</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work with minimal supervision</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif; color: #ffffff;">#LI - Remote</span></p>