Clinical Research Associate 2

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12.0pt;">Are you ready to redefine what’s possible, and discover your extraordinary potential at Labcorp? 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. 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;"><span style="font-size: 12.0pt;">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: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 18.0pt;">Essential Job Duties: </span></p><p style="margin: 0px;"><span style="font-size: 12.0pt;">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></p><ul><li><span style="font-size: 12.0pt;">Responsible for all aspects of site management as prescribed in the project plans </span></li><li><span style="font-size: 12.0pt;">General On-Site Monitoring Responsibilities: </span></li><li><span style="font-size: 12.0pt;">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;">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;">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><span style="font-size: 12.0pt;">Ensure the resources of the Sponsor and Labcorp 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><li><span style="font-size: 12.0pt;">Prepare accurate and timely trip reports </span></li><li><span style="font-size: 12.0pt;">Manage small projects under direction of a Project Manager/Director as assigned </span></li><li><span style="font-size: 12.0pt;">Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned </span></li><li><span style="font-size: 12.0pt;">Review progress of projects and initiate appropriate actions to achieve target objectives </span></li><li><span style="font-size: 12.0pt;">Organize and make presentations at Investigator Meetings </span></li><li><span style="font-size: 12.0pt;">Report, write narratives and follow-up on serious adverse experiences </span></li><li><span style="font-size: 12.0pt;">Participate in the development of protocols and Case Report Forms as assigned </span></li><li><span style="font-size: 12.0pt;">Participate in writing clinical trial reports as assigned </span></li><li><span style="font-size: 12.0pt;">Interact with internal work groups to evaluate needs, resources and timelines </span></li><li><span style="font-size: 12.0pt;">Act as contact for clinical trial supplies and other suppliers (vendors) as assigned </span></li><li><span style="font-size: 12.0pt;">Responsible for all aspects of registry management as prescribed in the project plans </span></li><li><span style="font-size: 12.0pt;">Undertake feasibility work when requested </span></li><li><span style="font-size: 12.0pt;">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;">Negotiate study budgets with potential investigators and assist the Labcorp legal department with statements of agreements as assigned </span></li><li><span style="font-size: 12.0pt;">Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs </span></li><li><span style="font-size: 12.0pt;">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;">Assist with training, mentoring and development of new employees, e.g. co-monitoring</span></li><li><span style="font-size: 12.0pt;">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><span style="font-size: 12.0pt;">Perform other duties as assigned by management</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: 'times new roman', times;"> </span></p><p style="margin: 0px;"><span style="font-size: 18.0pt;">Required Experience: </span></p><ul><li><span style="font-size: 12.0pt;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)</span></li><li><span style="font-size: 12.0pt;">In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered</span></li><li><span style="font-size: 12.0pt;">Fluent in English</span></li></ul><p style="margin: 0px;"> </p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 12pt;"><strong>Minimum Required:</strong></span></p><ul><li><span style="font-size: 12pt;">Advanced site monitoring skills</span></li><li><span style="font-size: 12pt;">Advanced study site management skills</span></li><li><span style="font-size: 12pt;">Advanced registry administration skills</span></li><li><span style="font-size: 12pt;">Ability to work with minimal supervision</span></li><li><span style="font-size: 12pt;">Good planning and organization skills</span></li><li><span style="font-size: 12pt;">Good computer skills with good working knowledge of a range of computer packages</span></li><li><span style="font-size: 12pt;">Advanced verbal and written communication skills</span></li><li><span style="font-size: 12pt;">Ability to train and supervise junior staff</span></li><li><span style="font-size: 12pt;">Ability to resolve project-related problems and prioritizes workload for self and team</span></li><li><span style="font-size: 12pt;">Ability to work within a project team</span></li><li><span style="font-size: 12pt;">Works efficiently and effectively in a matrix environment</span></li><li><span style="font-size: 12pt;">Valid Driver’s License</span></li><li><span style="font-size: 12pt;">Experience in monitoring device studies preferred </span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt;">Labcorp is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.</span></p>