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 clientCardiology and/or Hemophilia 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 assignedResponsible for all aspects of site management as prescribed in the project plansGeneral 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 studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure 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 policyTravel, including air travel, may be required and is an essential function of the job.Prepare accurate and timely trip reportsManage small projects under direction of a Project Manager/Director as assignedServe as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assignedReview progress of projects and initiate appropriate actions to achieve target objectivesOrganize and make presentations at Investigator MeetingsParticipate in the development of protocols and Case Report Forms as assignedParticipate in writing clinical trial reports as assignedInteract with internal work groups to evaluate needs, resources and timelinesAct as contact for clinical trial supplies and other suppliers (vendors) as assignedResponsible for all aspects of registry management as prescribed in the project plansUndertake feasibility work when requestedConduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requestedRecruitment 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 assignedNegotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedComplete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by managementAssist with training, mentoring and development of new employees, e.g.
co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assignedPerform other duties as assigned by managementEducation/Qualifications:Minimum Required:External CandidatesUniversity or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),ANDa minimum of 4 years of Clinical Monitoring experience.In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered.Internal CandidatesInternal candidates with a minimum of 4 years of clinical monitoring experience.Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countriesThorough understanding of the drug development processFluent in local office language and in English, both written and verbalPreferred:Thorough knowledge of Covance SOPs regarding site monitoringCovance 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.Experience:Minimum Required:External CandidatesUniversity or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),ANDa minimum of 4 years of Clinical Monitoring experience.In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered.Internal CandidatesInternal candidates with a minimum of 4 years of clinical monitoring experience.Monitoring experienceHave a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsAdvanced site monitoring skillsAdvanced study site management skillsAdvanced registry administration skillsAbility to work with minimal supervisionGood planning and organization skillsGood computer skills with good working knowledge of a range of computer packagesAdvanced verbal and written communication skillsAbility to train and supervise junior staffAbility to resolve project-related problems and prioritizes workload for self and teamAbility to work within a project teamWorks efficiently and effectively in a matrix environmentValid Driver’s LicensePreferred: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 preferredLocal project coordination and/or project management