OCKHAM CRO FULL

* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

* Basic understanding of the drug accountability process * Thorough knowledge of monitoring procedures * Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements * A minimum of at least 9 months of Onsite Clinical Monitoring experience and 2 years total in clinical research experience is required. An equivalent amount of experience can be substituted as appropriate. * University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). * Independently perform CRF review query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management * Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested * Undertake feasibility work when requested * Responsible for all aspects of registry management as prescribed in the project plans

OCKHAM CRO TRIAL

* Act as contact for clinical trial supplies and other suppliers (vendors) as assigned * Interact with internal work groups to evaluate needs, resources and timelines * Participate in writing clinical trial reports as assigned * Participate in the development of protocols and Case Report Forms as assigned * Organize and make presentations at Investigator Meetings * Review progress of projects and initiate appropriate actions to achieve target objectives * Prepare accurate and timely trip reports * Travel, including air travel, may be required and is an essential function of the job. * Responsible for all aspects of site management as prescribed in the project plans * 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 So not matter where you are locating on the globe we have an FSP opportunity for you. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. This allows your expertise to shine through as you also become engrained in the sponsor culture helping to bring more therapies out to patients. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio. You will enjoy the best of both worlds-all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise. Dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.

Who doesn't want twice the perks - working at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. Covance by labcorp gives you the best two for one opportunity for career growth. Clinical Research Associate II, FSP Non-Oncology Ontario, Canada Why settle for one thing when you can have everything.

Ockham cro