Clinical Research Associate I or II
CRA I or II - KS, IA or MN
Why settle for one thing when you can have everything. Covance by labcorp 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.
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 our 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.
Our 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.
Our 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:
- 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
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports
- 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
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
- 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.
- COVID-19 vaccination required
- A minimum of at least 9 months of Onsite Clinical Monitoring experience and 2 years total in clinical research experience is required.
- Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
- Thorough knowledge of monitoring procedures
- Basic understanding of the drug accountability process
- Valid Driver's License
- 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
#LI - Remote
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