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Job #03276

About our client Our client is a clinical supply company based in Phoenix, Arizona. They focus on supplying the global clinical world with products that improve health care. Their products range from surgical materials, needles, personal care items to lab products and uniforms. They boast two distribution warehouses in Phoenix that handle products arriving daily from their manufacturing facilities located both in the US and on the Pacific Rim. They strongly believe in creating a working environment for people with a drive for success, an entrepreneurial spirit and a family-oriented nature. They have many programs that reward employees for their dedication and contributions. This is an excellent opportunity for the right candidate! Position Location Clinical Research Associate Phoenix, Arizona Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate proactively in planning, preparing (writing/editing), managing, analyzing, reporting, training and coordinating all clinical trials, technical studies as well as research projects 2) Assist in developing all clinical research documents, training materials, CRFs, investigator brochures, etc., ensuring appropriate accuracy, completeness and reading level (physician, staff, patient etc.) 3) Oversee project staffing requirements and tracking supplies to clinic and Investigator 4) Provide ongoing, objective updates on progress and problems with projects as well as track and follow up on action items 5) Assist clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up as well as throughout the conduct of the study 6) Conduct on-site training and educational sessions at clinical trial sites 7) Ensure clinical investigators and trial personnel are well informed and understand the expectations and requirements of the studies 8) Monitor clinical activities to identify issues, variances and conflicts as well as analyze/recommend solutions 9) Conduct ongoing site visits throughout the course of the trials/research projects to ensure regulatory and protocol compliance 10) Manage requirements of GCP, SDV requirements, AE reporting, CRFs, patient information sheets and informed consent 11) Handle requirements for the Ethical Committee, supplies presentation, storage and accountability, biological sample preparation, storage as well as transportation 12) Maintain awareness of local regulatory requirements and to conduct studies as per IPC SOPs, other guidelines and ICH GCP guidelines 13) Liaise with investigators or site staff during studies to ensure proceedings are as per agreed protocols and time schedules as well as the data being recorded is accurate and returned to IPC in the required timescales 14) Review all data produced from each study and resolve any data queries/protocol deviations identified 15) Liaise with the safety officers to clarify, respond to/and resolve adverse events as they arise 16) Conduct source data verification (as required) to data monitoring guidelines 17) Ensure that data is entered into the database and is secured 18) Manage other project-related tasks as appropriate (e.g. in-house assessments, studies, health screenings, planning of Investigator meetings, etc.) and non-project related tasks (if required) 19) Track the progress of the study by providing routine reports (as required) of the status of the studies as well as make any necessary recommendations for contingency planning 20) Maintain effective communication with other members of the Clinical Team and management 21) Manage all practical arrangements (e.g. budgets, supplies, travel, etc.) Requirements 1) B. Sc. in Life Sciences 2) 2 – 3 years of experience in the pharmaceutical or biologic industry with CRO/clinical trial monitoring experience either as a CRA or a CRC 3) Official CRA training (participation in a CRA training course) 4) Expertise in dermatology/allergies preferred 5) Knowledge of GCP guidelines, medical terminology and clinical trial processes 6) Biostatistics experience preferred 7) Excellent communication (written and verbal) and organizational skills 8) Superb IT (MS Office, Adobe Acrobat, Access, etc.) skills with strong attention to detail 9) Willingness to travel domestically and internationally (up to 70%)