Clinical Research Associate II

US-PA-Conshohocken Job posted on: 5/6/2008 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.  Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! Seeking CRA2s I. Job Summary: • Assures the implementation of project plans as assigned. • Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP. • Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP. • Registry management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, where applicable. • Act in the project role of Lead CRA as assigned. A. Duties and Responsibilities: • Responsible for all aspects of study site monitoring including in-house site monitoring, routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, EDC review (where applicable); liaise with vendors; and other duties, as assigned. • Responsible for all aspects of site management as prescribed in the project plans. • Responsible for all aspects of registry management as prescribed in the project plans, where applicable. • Undertake feasibility work when requested. • Provide coverage for clinical contact telephone lines, as required. • Assist with collection, review, tracking and preparation of regulatory documents as required. • 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. • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned. • Track and follow-up on serious adverse events 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. • Assist with training, mentoring, evaluation and development of new employees, e.g. co-monitoring, as assigned. • Co-ordinate designated clinical projects (with supervision, if applicable), and may act as a local client contact as assigned. • General Monitoring Responsibilities (a) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. (b) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. (c) 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. (d) 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. (e) Prepare accurate and timely trip reports. • Perform other duties as assigned by management. B. Principal Contacts • Internal – Project team members, Other Covance units and departments • External - Study sites, clients C. Travel Requirements: Yes • Ability to drive and have a valid driver’s license. D. Language Skills Required: • Speaking: Yes English • Writing/Reading: Yes English Experience Required: • Minimum of two (2) years of clinical research monitoring experience to include one (1) year on-site monitoring experience (including pre-study, initiation, routine monitoring and/ or closeout visits). • Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines. • Have a full understanding of the Serious Adverse Event (SAE) reporting process. • Good planning, organization and problem solving abilities. • Ability to work with minimal supervision. • Good communication and interpersonal skills. • Participation in client interactions, as assigned. • Good analytical and negotiation skills. • Computer competency. • Fluent in local office language and in English, both written and verbal. • Works efficiently and effectively in a matrix environment Preferred: • One (1) 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. Education Required: • University/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 will be considered • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements. • Thorough knowledge of monitoring procedures. • Basic understanding of the clinical trial process. Preferred: • Thorough knowledge of Covance S.O.P.s for site monitoring. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). 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