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Location

Hammersmith, Greater London | United Kingdom

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Job description

Clinical Trial Associate - Contractor

• Duration - 6 months
• Working Pattern – 5 days - Monday, Wednesday, and Thursday in the London office.

Role Summary
You will be responsible for supporting 1-3 project teams and will manage multiple administrative aspects of clinical trials across all project stages including start-up, enrolment, study conduct, and close-out.
You will ensure work products are in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
Key Responsibilities

• Support execution of clinical trials in all aspects of clinical operations from study inception to completion, including:
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
• Actively participates in study feasibility efforts in conjunction with the Clinical Project Manager (CPM).
• Responsible for performing end-to-end drug accountability in collaboration with the study team.
• Prepare and track study documents (e.g., contracts, budgets, IEC/IRB documentation).
• Support with vendor management and associated logistics, as assigned.
• Plan investigator meetings and preparing site training materials in collaboration with the study team.
• Contribute to the creation of presentations, as needed for projects, departmental, sponsor and/or business development needs.
• Provide input for budget development and check monthly costs invoiced based on planned study activities and review of the RFP in collaboration with the CPM.
• Collaborate with business functions to manage study related payments. Interact with external provides during study conduct (e.g., Clinical Research Organization (CRO), Clinical Research Associates (CRAs) and occasionally with investigators and hospital personnel).
• Supports CRA’s and others with the preparation, handling, and distribution of clinical trial supplies and maintenance tracking of information.
• Participate in the preparation of study-specific documentation (e.g., study reference manuals).
• Organize, facilitate, and provide logistical support for the study team, scheduling meetings, distributing agendas, and writing minutes.
• Facilitate training of internal and external CRAs, CRO team members, and investigative site staff.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• Assist in creating, updating and implementing departmental procedures.

Responsibilities / Accountabilities

• Provide general assistance and support to the Global Clinical Operations Department and to CPM(s).
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• Review and input into study specific documentation and guidelines as appropriate.
• Set up, organize and maintain clinical study documentation (e.g., Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Assist in quality control audits of clinical study documentation (e.g., Main Study Files, CRF Files, Monitoring Files, etc.).
• Direct project teams with trial progress tracking by updating the Clinical Trial Management Systems (CTMS).
• Submit system requests for the Clinical Operations teams and vendor representatives when applicable.
• Conduct initial submission QC in Veeva Vault and assist in completing quarterly QC of the TMF.
• Complete study metric trackers and reports.
• Co-ordinate document translation, if required.
• Assist in the production of slides, etc., as needed for project, departmental, and/or business development presentations. Manage and co-ordinate study team member tracking.
• Other duties as assigned.

Requirements
Education:

• Bachelor’s degree (BSc, BA or RN equivalent) in biological or science-related field is essential and/or combination of education and experience.

Experience:

• Demonstratable experience in similar position within Biotech, Pharmaceutical or CRO industry and in R&D environment.
• Must have worked Sponsor-side at a Biotech and/or Pharmaceutical company.
• Extensive experience managing electronic TMF, including set-up, maintenance, QC/QR and query management. Familiar with DIA reference model.
• Knowledge of ICH/GCP and applicable regulations.
• Experience in cell/gene therapy clinical trials.
• Experience in Hematology/Oncology Clinical Trials.
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive timelines.
• Experience in performing inspection readiness activities.

Skills/Specialist Knowledge:

• Proficiency in Microsoft Office Suite of Products (Word, Excel, Power Point etc.).
• Experience in eDC systems (e.g., Rave EDC).
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Excellent oral and written communication, and planning skills.
• Willingness to travel as needed.

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Salary