Clinical Research Support Specialist

Velocity Clinical Research, Inc.; Plymouth; Presencial; GBP 21.000 - 27.000; Jornada completa

Descripción de la vacante

Velocity Clinical Research, Inc. is seeking a Clinical Research Assistant to support the Clinical Operations Team in conducting clinical research studies.

You will perform clinical, laboratory, administrative, and data management activities while ensuring compliance with UK GCP, MHRA requirements and SOPs. You will assist with data collection and documentation, support participant recruitment, and maintain confidentiality in accordance with UK GDPR.

Formación

• GCSEs (or equivalent) in English and Mathematics.
• Previous experience in healthcare, clinical research, laboratory sciences, or a related life sciences environment.
• Level 3 qualification, such as A-Level, BTEC, NVQ, or equivalent, in a life sciences, healthcare, or scientific discipline.
• Knowledge of GCP principles.

Responsabilidades

• Assist in the conduct of clinical trials in accordance with study protocols, UK GCP, ICH-GCP guidelines, MHRA requirements, and Company SOPs.
• Perform venepuncture, capillary blood collection, and other protocol-required specimen collection procedures within the scope of training, competency, and applicable requirements.
• Support clinical assessments, including vital signs, ECGs, phlebotomy, and other protocol-specific procedures under appropriate supervision.
• Process, package, and ship laboratory specimens in accordance with protocol requirements, IATA regulations, and applicable UK requirements.
• Maintain laboratory, study, and clinical supplies, including inventory tracking and replenishment.
• 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.
• Ensure accurate, complete, and timely documentation in accordance with Good Documentation Practice standards.
• Communicate effectively with participants, colleagues, investigators, sponsors, CROs, and vendors.
• Support informed consent discussions and processes, ensuring participant understanding and ongoing consent in accordance with GCP requirements.
• Assist with the preparation, maintenance, and filing of essential study documentation and regulatory records.
• Support participant recruitment and retention activities, including pre-screening potential participants by telephone or in person.
• Maintain strict confidentiality of participant, sponsor, and Company information in accordance with UK GDPR and the Data Protection Act 2018.
• Escalate participant safety concerns, adverse events, SAEs, and other safety issues promptly to the Clinical Research Team.
• Maintain clean, organised, and compliant clinical and laboratory environments.
• Prepare source documentation and file study-related documents and medical records as required.
• Provide administrative support, including answering telephone calls, scheduling participant visits, issuing reminders, and maintaining participant tracking systems.
• Perform other duties as assigned.

Conocimientos

Strong communication

Organisational skills

Attention to detail

Teamwork

Regulatory knowledge

Educación

GCSEs in English and Mathematics

Level 3 qualification in life sciences/healthcare

Herramientas

Microsoft Office

Descripción del empleo

Velocity Clinical Research, Inc. is seeking a Clinical Research Assistant to support the Clinical Operations Team in conducting clinical research studies.

You will perform clinical, laboratory, administrative, and data management activities while ensuring compliance with UK GCP, MHRA requirements and SOPs. You will assist with data collection and documentation, support participant recruitment, and maintain confidentiality in accordance with UK GDPR.