Senior Clinical Research Associate
Senior Clinical Research Associate I
Massachusetts, New Jersey, New York or Pennsylvannia
Why settle for one thing when you can have everything. Covanceby labcorp gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at 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, we have 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 and management 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
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms as assigned
- 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
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
#LI - Remote
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
- Thorough knowledge of regulatory requirements
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal
- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- COVID-19 vaccination required
- Thorough knowledge of company SOPs regarding site monitoring
- Two (2) years of Clinical Monitoring experience
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
- One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
- Local project coordination and/or project management experience
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