Clinical Research Associate - United Kingdom
- 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:
- Embed Compliance Culture across all areas of the business ensuring Integrity in Action is actively applied in all initiatives.
- Ensure adherence to company policies relating to Ethics and Compliance standards.
- Conduct feasibility, pre-selection, initiation, monitoring and close-out visits of company 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 company SOPs.
- Ensure complete and efficient exchange of information between the investigator site and company 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
- 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).
Keep training records up to date. Responsible for personal development and training
Other such duties as may be reasonably required by the business.
Core Tasks, Responsibilities and Authority– stored in separate document entitled ‘AGREED Compliance Text Categories’.
Review and approval to CTA for processing under the relevant study PO.
- 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).
Competencies | Experience
- 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.
- Understands how personal/team objectives contribute to company’s 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.
- Ability to work autonomously and make evidence-based decisions: judgement to know when to seek guidance or escalate
- Methodical with ability to prioritize 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.)
- (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.
- 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.