職位描述
藥品臨床監查
職位描述 CRAI
Duties and Responsibilities (including but not limited to):
- Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
- Conduct study feasibility and site selection activities
- Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
- Assist with investigator meeting activities including organization, preparation and attendance
- Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
- Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
- Establish and maintain good rapport with study sites.
- Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
- Representation of CRAs during an audit or inspection when assigned
- Coordinate timely shipment of clinical supplies and study drug to sites.
- Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
- Maintain adequate site tracking records
- Follow up of drug safety issues and safety reports in timely manner, if applicable
- Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly
- Develop and implementation of corrective actions when appropriate
- Assist with data query form (incl. query process)
- Prepare /review all patients tracking records
- Input and maintain study information concerning subject status of financial reimbursement to sites.
- Conduct and assist with administrative activities as a member of the project team.
- Bachelor’s Degree in allied health fields: Medical, Nursing, Pharmacy, Psychology, Veterinary or Health Science
- Minimum of 1 years experience as a Clinical Research Associate
- Excellent verbal and written communication skills
- Good verbal and written English language skills
- Strong computer literacy e.g. MS word, Excel, PowerPoint, internet
- Excellent organizational, record retention, and time management skills
- Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements
工作地點
北京朝陽區正大中心-南塔
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愛恩康臨床醫學研究(北京)有限公司At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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