385 jobs in Oban, Argyll And Bute

Clinical Research Associa...

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ICON PLC, Scotland-wide.

  • Full time
  • Permanent

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Posted 5 days ago, 15 Jan

Support Worker - Teesside...

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The Avalon Group, Scotland-wide.

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Group Financial Services ...

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Yorkshire Building Society, Scotland-wide.

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Posted 5 days ago, 15 Jan

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Mental Health CYP Case Ma...

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IPRS Health, Scotland-wide.

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Quality Auditor

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Hallmark Luxury Care Homes, Scotland-wide.

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Regional Head of Delivery...

£85464

Fortis Living, Scotland-wide.

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Research Fellow

£19553

University of Surrey, Scotland-wide.

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Solutions Director

£85000

Sopra Steria Limited, Scotland-wide.

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Fundraising and Partnersh...

£67934

Royal National Lifeboat Ins titution (RNLI), Scotland-wide.

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Sitel Group & Sykes are n...

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Sykes Enterprises, Scotland-wide.

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Assistant Project Manager

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Thales Group, Scotland-wide.

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Field Events Co-ordinator

£38706

British Medical Association, Scotland-wide.

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Administrator - Pay Servi...

£26000

Royal Mail, Scotland-wide.

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Head of Quality and Post ...

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Fortis Living, Scotland-wide.

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Senior Electrical Estimat...

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Balfour Beatty PLC, Scotland-wide.

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National Account Manager

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Matthew Clark, Scotland-wide.

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Hotel Duty Manager - Live...

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HR-CL Ltd, Dunbeg, Argyll and Bute

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Heavy Mobile Plant Fitter

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Aggregate Industries, Oban, Argyll and Bute

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Regulatory Services Offic...

£30,001 - £40,000

Argyll & Bute Council, Oban, Argyll and Bute

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Posted 6 days ago, 13 Jan

Houseparent - ARB15494

£20,001 - £30,000

Argyll & Bute Council, Soroba, Argyll and Bute

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Posted 6 days ago, 13 Jan
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Clinical Research Associate - Hematology experience

Salary not available. View on company website.

ICON PLC, Scotland-Wide.

  • Remote working
  • Full time
  • Permanent

Posted 5 days ago, 15 Jan

Job ref: b84ac61ed520421fa311303e456e1f9c

Full Job Description

As a SCRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Your ultimate responsibility as a SCRA include ensuring trial sites are inspection ready through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), International Conference on Harmonization for Good Clinical Practice (ICHGCP), applicable regulations from start-up through data-base lock. Additional responsibilities:

  • Perform all the site management services
  • Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
  • Complies with relevant training requirements.
  • Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team, as required.
  • Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
  • Drive study compliance by executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
  • Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
  • Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
  • Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines.
  • Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
  • Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at all times.
  • Focuses on Investigator engagement through timely follow up with sites. Completes follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team within 15 working days of monitoring visit. Promptly communicates relevant status information and issues to appropriate stakeholders. Follows the corresponding
  • Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
  • Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
  • If applicable, will support negotiation of investigator budgets at site level, support tracking of costs and ensure payments are made at site level, maintaining site relationships.
  • May participate in the HA and IEC/IRB submission and notification processes as
  • Autonomy in execution of site management services
  • Depth of knowledge with site management services
  • Process leadership
  • May provide monitoring support, to less experienced site managers

    Right to work in the UK
  • 3 to 5+ years of clinical trial monitoring experience.
  • BA/BS degree/Degree in a health or science related field or equivalent industry experience
  • Experience working on Hematology trials
  • Working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including
  • monitoring guidelines.
  • Demonstrate proficiency in IT skills for appropriate software and company systems.
  • Willingness to travel with overnight stay away from home according to business needs.
  • Proficient in speaking and writing in English and the country language where services will be provided
  • Effective communication skills, oral and written.
  • Experience with monitoring and site management of complex Early Phase of clinical development, as applicable

    As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
  • ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world's leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact. Why choose a career with ICON Strategic Solutions? Meaningful Work: You'll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives. Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally. Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently. Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization. Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

    Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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Direct job link

www.s1jobs.com/job/clinical-research-associate-hematology-experience-124472527

About this company

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