Clinical Research Associate II (Unblinded monitoring, national travel USA)

Covance - Charlotte, NC

Job Overview:
Discover new opportunities to grow your career as a Covance FSP CRA

Why settle for one thing when you can have everything. Covance gives you the best two for one opportunity for career growth. 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.
As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. 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.
You will enjoy the best of both worlds—all the benefits that come along with Covance’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio. This allows your expertise to shine through as you also become engrained in the sponsor culture helping to bring more therapies out to patients.
Covance’s FSP model is flexible and scalable. 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.
Covance’s reach is global – extending to 60+ countries making us one of the largest FSP CROs. So not matter where you are locating on the globe we have an FSP opportunity for you.
Essential Job Duties: Working within an FSP model, embedded within a client Monitoring experience 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 Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 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 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 Travel, including air travel, may be required and is an essential function of the job. Prepare accurate and timely trip reports Manage small projects under direction of a Project Manager/Director as assigned Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned Review progress of projects and initiate appropriate actions to achieve target objectives Organize and make presentations at Investigator Meetings Participate in the development of protocols and Case Report Forms as assigned Participate in writing clinical trial reports as assigned Interact with internal work groups to evaluate needs, resources and timelines Act as contact for clinical trial supplies and other suppliers (vendors) as assigned Responsible for all aspects of registry management as prescribed in the project plans Undertake feasibility work when requested Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested 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 Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management Assist with training, mentoring and development of new employees, e.g. co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management

Minimum Required: 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. Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements Thorough knowledge of monitoring procedures Basic understanding of the clinical trial process Valid Driver's License

Preferred: Thorough knowledge of Company SOPs regarding site monitoring Experience: Minimum Required: A minimum of 2 year of Onsite 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. Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Good planning, organization and problem-solving abilities Ability to work with minimal supervision Good communication and interpersonal skills Good analytical and negotiation skills Computer competency Fluent in local office language and in English, both written and verbal Worksefficientlyandeffectivelyinamatrixenvironment

Preferred: Two (2) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred, however an equivalent combination of education and experience to successfully perform the key responsibilities of the job.