Us Covance Gaithersburg, MD, USA
Jul 16, 2018Full-time
Overview:Clinical Research Associate II/Senior Clinical Research Associate (Sponsor Dedicated & home based)(Remote and home-based)Are you ready to make a truly rewarding career change? In this unique CRA you will work closely with an exciting Pharmaceutical client in the cutting edge area of Oncology! As an experienced CRA you ll be involved in initiation, routine & close out visits. Redefine what s possible, and discover your extraordinary potential at Covance!A career here provides the unique chance to create a lasting impact and difference in our patient s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you ll be empowered to own your career journey with mentoring, training and personalized development planning.Essential Job Duties:Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.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 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 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 review. Monitor 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 policyPrepare 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 as assignedReview progress of projects and initiate appropriate actions to achieve target objectivesOrganize and make presentations at Investigator MeetingsReport, write narratives and follow-up on serious adverse experiencesParticipate 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 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-monitoringCo-ordinate 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 managementMultiple positions are available! Please specify your preference for Eastern, Western or Central US.Education/QualificationsUniversity/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e. g., nursing certification, medical or laboratory technology)In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be consideredCovance 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.Experience2+ years Monitoring Experience.Ability to monitor sites independently.Experience working directly with a client strongly preferred.2 or 3 years Oncology or General Medicine experience required.