Clinical Research Associate I - Monitoring Excellence Academy

<h2>Job Overview:</h2><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Clinical Research Associate I</strong></span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Monitoring Excellence Academy</strong></span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Montreal or Toronto, Home-Based, Remote</strong></span></p><p style="margin: 0in; margin-bottom: .0001pt;"> </p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Start date: November 29, 2021</strong></span></p><p style="margin: 0in; margin-bottom: .0001pt;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Are you ready to redefine what’s possible, and discover your extraordinary potential at Labcorp Drug Development? </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative workplace, along with access to comprehensive benefits. </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Conducts site monitoring of clinical research studies according to our Standard Operating Procedures, ICH Guidelines and GCP.</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"> </span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide clinical support for project according to Covance Standard Operating Procedures, ICH Guidelines and GCP.</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"> </span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Site management responsibility for clinical studies according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.</span></p><p style="margin: 0in; margin-bottom: .0001pt;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Essential Job Duties: </span></p><ul><li style="color: #000000;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for aspects of registry management as prescribed in the project plans</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">General On-Site Monitoring Responsibilities:</span><ul><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Monitor data for missing or implausible data</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 Labcorp travel policy</span></li></ul></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Travel, including air travel, may be required as per essential job functions.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prepare accurate and timely trip reports</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance by Labcorp or client data management systems, as assigned by management</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide coverage for clinical contact telephone lines, as required</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Update, track and maintain study-specific trial management tools/systems</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Generate and track drug shipments and supplies, as needed</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Track and follow-up on serious adverse events as assigned</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Implement study-specific communication plan as assigned</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Attend investigators’ meetings, project team meetings and teleconferences, as needed</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform other duties as assigned by management</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="list-style-type: none;"><ul><li style="color: #000000;"><span style="color: #1a1a1a; font-family: arial, helvetica, sans-serif; font-size: 12pt;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt; margin-top: 0.95pt; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #1a1a1a;">AND</span> </span></li><li style="color: #000000;"><span style="color: #1a1a1a; font-family: arial, helvetica, sans-serif; font-size: 12pt;">A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)</span></li></ul></li></ul><h2>Experience:</h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements</span></li><li style="color: #000000;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Basic understanding of the clinical trial process</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Valid Driver’s License</span></li></ul>