Overview:
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Summary:
The Clinical Research Assistant supports the Clinical Operations Team in the conduct of clinical research studies by performing clinical, laboratory, administrative, and data management activities. The role assists with the collection, documentation, and maintenance of clinical trial data while ensuring compliance with study protocols, UK Good Clinical Practice (GCP), Medicines and Healthcare products Regulatory Agency (MHRA) requirements, and Company Standard Operating Procedures (SOPs).
Responsibilities:
Duties/Responsibilities:
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Assist in the conduct of clinical trials in accordance with study protocols, UK GCP, ICH-GCP guidelines, MHRA requirements, and Company SOPs.
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Perform venepuncture, capillary blood collection, and other protocol-required specimen collection procedures within the scope of training, competency, and applicable requirements.
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Support clinical assessments, including vital signs, electrocardiograms (ECGs), phlebotomy, and other protocol-specific procedures under appropriate supervision.
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Process, package, and ship laboratory specimens in accordance with protocol requirements, IATA regulations, and applicable UK requirements.
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Maintain laboratory, study, and clinical supplies, including inventory tracking and replenishment.
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Enter source data into sponsor and/or vendor electronic systems and assist in resolving basic data queries under the guidance of the Clinical Research Coordinator.
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Ensure accurate, complete, and timely documentation in accordance with Good Documentation Practice standards.
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Communicate effectively with participants, colleagues, investigators, sponsors, Contract Research Organisations (CROs), and vendors.
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Support informed consent discussions and processes, ensuring participant understanding and ongoing consent in accordance with GCP requirements.
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Assist with the preparation, maintenance, and filing of essential study documentation and regulatory records.
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Support participant recruitment and retention activities, including pre-screening potential participants by telephone or in person.
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Maintain strict confidentiality of participant, sponsor, and Company information in accordance with UK GDPR and the Data Protection Act 2018.
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Escalate participant safety concerns, adverse events (AEs), serious adverse events (SAEs), and other protocol-defined safety issues promptly to the Clinical Research Team.
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Maintain clean, organised, and compliant clinical and laboratory environments.
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Prepare source documentation and file study-related documents and medical records as required.
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Provide administrative support, including answering telephone calls, scheduling participant visits, issuing reminders, and maintaining participant tracking systems.
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Perform other duties as assigned.
Qualifications:
Education/Experience:
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Essential
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GCSEs (or equivalent) in English and Mathematics.
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Previous experience in healthcare, clinical research, laboratory sciences, or a related life sciences environment.
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Desirable
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Level 3 qualification, such as A-Level, BTEC, NVQ, or equivalent, in a life sciences, healthcare, or scientific discipline.
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Previous experience within a clinical research setting.
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Knowledge of GCP principles.
Required Skills:
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Basic knowledge of medical terminology.
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Strong verbal and written communication skills.
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Good organisational and time-management abilities.
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Ability to work effectively within a multidisciplinary team.
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Ability to follow written procedures and regulatory requirements.
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Proficiency in Microsoft Office applications and standard office technology.
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Strong attention to detail and commitment to data accuracy.
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Ability to manage multiple priorities in a fast-paced environment.
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Flexibility and adaptability to changing study and site requirements.
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Commitment to participant safety, confidentiality, and quality standards.
NOTE: The duties and responsibilities described above are intended to describe the general nature and level of work performed in this position. They are not an exhaustive list of all duties, responsibilities, or qualifications required. Duties may change based on business and operational requirements.
