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Clinical Research Associate Endon United Kingdom,  

Posted on : 13 May 2017

Project Description

Job Title: Clinical Research Associate Job Family: Clinical Operations Department: Medical Grade: 8 Competency: Associate Date: January 2017 Hay Evaluated   JEM Reference Hay   JEM Ref   Date: Xx/xx/16 HCC Compliance Category: Category 0, 1, 2, 3  (edit)   Organisational Fit: Reports to:     Clinical Operations Manager or Clinical Research Manager  Peers: Senior CRAs, Senior CTA and Affiliate Study Leads Subordinates: Clinical trials Administrator   Purpose of the Position: To work within ICH-GCP guidelines, CT Directive, UK regulations and company SOPs. Primarily to provide monitoring support to company driven studies (phase IIIb-IV) with sites in the UK. Deliver patients into these studies by actively managing site recruitment.     Core Tasks, Responsibilities and Authority:     Compliance Embed Compliance Culture across all areas of the business ensuring Integrity in Action is actively applied in all initiatives. Ensure adherence to Astellas policies relating to Ethics and Compliance standards.   Clinical Trials Conduct feasibility, pre-selection, initiation, monitoring and close-out visits of Astellas clinical studies in accordance with relative SOPs and regulations Ensure rapid retrieval of all clinical data, especially with regards to reporting of (serious) adverse events, in accordance with relevant protocol and Astellas SOPs.   Communications Ensure complete and efficient exchange of information between the investigator site and Astellas by regular on-site visits, telephone calls, email etc. Establishing and maintaining a working relationship with the investigator and all relevant site staff. Ensure high quality clinical data by detailed monitoring of data, source data verification, query resolution and maintenance of equipment etc. Ensure that all necessary documents are in place for release of study medication to site, monitor drug accountability at site, account for all medication (used/unused) and ultimate destruction. Assist in MREC and R&D application for studies. Will ensure that all necessary approvals and documents are available/signed before (or at) site initiation     Administrative Responsible for filing and maintenance of Site Files for assigned sites, and where relevant Country Files (ie periodically reviews files and maintains checklist).  At end of study will conduct final check for files ready for review prior to archiving. Liaise with CTA in preparing site payments.  Track payments versus schedule of payments and work done by sites. Maintain site status in Impact (CTMS).   Training Keep training records up to date. Responsible for personal development and training     Other such duties as may be reasonably required by the business.   ALL:  Compliance TRAINING Category:  Paste text for Approved Mandatory Compliance TRAINING Category  i.e. Category 0, 1, 2, 3 (plus any additional specialist categories e.g. Zinc) in this section i.e. Core Tasks, Responsibilities and Authority– stored in separate document entitled ‘AGREED Compliance Text Categories’.       Quantitative Dimensions: Review and approval to CTA for processing under the relevant study PO.   Interpersonal Relationships: Internal ·         Employees at all levels within the UK Affilate ·         All APL departments ·         European personnel (RSMs and ESMs) ·         Work with relevant study team members External NHS Clinical staff at Investigational sites NHS R&D staff with relevant Trusts     Specific Physical Abilities: Significant travel within the UK and some occasional European travel (including overnight stays). Full driving license (UK).     Specific Environmental Factors: Based at the EMEA Operations Headquarters - Chertsey, Surrey, UK Willing to work additional hours as required by the business.   Professional Profile Competencies Experience   Customer Focus:- Acts to support a culture where everything is done to enhance value to patients.  Intentional about meeting/exceeding customer expectations. Proactively seeks feedback to improve service provision.   Strategic Orientation: Understands how personal/team objectives contribute to Astellas’ strategy and functional goals.   Balances ‘bigger picture’ goals and operational requirements, overcoming challenges/barriers to delivery.   Innovation &  Change: Identifies improvements and generates new ideas, methods or solutions.   Positively embraces change. Continuous improvement approach; takes personal ownership to improve ways of working and leverage/share best practice.   Results Orientation: Ability to work autonomously and make evidence-based decisions: judgement to know when to seek guidance or escalate Methodical with ability to prioritise and meet deadlines.  Tenacious to follow up and resolve outstanding matters and explore options. Excellent attention to detail and financial awareness (raise/process/track Purchase Orders etc.) IT literate (Intermediate stage) to type/ create and edit reports, trackers etc. Excel, Word, PowerPoint, Outlook and eLearning and online systems (e.g. LMS, ZINC, TMF etc databases).  Intranet and web.  Good written and verbal communications including ability to prepare updates, summaries, emails to employees and managements.   Communication & Collaboration: Collaborates: values others views and perspective.  Able to challenge respectfully and propose alternative solutions.  Proactively shares knowledge, and adapts approach to build consensus and respect diverse views and cultures.   Developing & Inspiring: Proactively shares knowledge and best practice and encourages others to develop. Learns from own/others experience and proactively seeks to develop personal capability. Regularly seeks feedback on personal contribution and growth areas.   Working as One Astellas: Takes personal ownership and acts as a role model of ethics and compliance treating everyone with respect. Provides honest, constructive and timely feedback.  Seeks feedback on own contribution and ways of working.     Demonstrable on-site monitoring experience. Good communication skills, both verbal and written. Fluent in English. Able to prioritize and deal with a demanding workload. Excellent attention to detail. Good planning and organizational skills. Team player. Resourceful and self-starting Ability to drive; ‘clean’ driving licence.                                         Signed: ……………………………………………………………..     Name ……………………………………………………………… (Block capitals)     Date:- ……………………………………………………2016     Return signed hard copy to HR Function for personnel file.                     Location: Hillswood


Hillswood United Kingdom

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