Background:
CyDen is a British health and beauty company known for developing and manufacturing Intense Pulsed Light (IPL) hair removal devices for home use. Our innovative electronic beauty products are globally distributed across household and medical markets under widely recognized brand names. CyDen offers a dynamic, fast-paced environment with a supportive and welcoming team culture. We're seeking a dedicated and detail-oriented Clinical Trial Assistant to join our expansive clinical research team.
The Role
The Clinical Trial Assistant (CTA) will work hands-on in CyDen's newly established Research Facility in London, performing high-rigor clinical research activities under time-sensitive constraints. This role involves thorough training and testing, with extensive resources provided. Reporting to the Clinical Operations Coordinator and working under the Principal Investigator's direction, the CTA will support daily clinical trial operations, from study preparation and recruitment through to closeout.
Following training, the CTA will independently manage patient appointments, administer investigational treatments, capture high-quality, real-time photos, and conduct non-invasive skin measurements. You will also liaise with participants, providing detailed information and ensuring accurate data management.
This position requires flexibility with shift patterns, including evening work, and strong communication skills to work within our team-based, collaborative culture.
Overall job purpose:
- Support the planning, coordination, and administration of clinical trials to ensure they are conducted accurately, efficiently, and in compliance with regulatory and ethical standards. This role is essential for maintaining trial documentation, managing participant appointments, ensuring data accuracy, and upholding Good Clinical Practice (GCP) and study protocols.
- Perform administrative and clinical tasks that facilitate the trial's progress, including data entry, documentation management, communication with participants, and coordination with clinical team members.
- Provide valid, high-quality data that contributes to the safety and efficacy evaluations necessary for advancing products and treatments.
Key Responsibilities:
- Trial Preparation: Prepare and review all study-related documents before study commencement.
- Participant Recruitment: Recruit and maintain contact with trial participants throughout the study.
- Scheduling: Maintain an accurate and up-to-date appointment schedule.
- Informed Consent: Conduct the informed consent process with all participants.
- Protocol Adherence: Execute clinical activities according to study protocols, including device treatments, photography, and skin measurements.
- Data Management: Ensure complete and accurate Case Report Form (CRF) entries during trials and transcription of raw data.
- Patient Monitoring: Monitor and report patient status, safety, adverse events, and device effects.
- Inventory Management: Monitor clinical suite supplies and replenish as needed.
- SOP Development: Assist in creating and updating Standard Operating Procedures.
- Quality Control: Promptly address and report concerns arising during studies and maintain utmost confidentiality.
Key objectives/KPI's
- Data accuracy and quality
- Timeliness of document management
- Adherence to study protocols
- Patient recruitment and retention rates
- Timeliness in management of participant appointments
- Response time to participant queries
- Monitoring and reporting Adverse Events
- Inventory and supply management
- Continuous improvement and training participation
- Audit and inspection readiness
Skills, know-how & experience:
Must Have:
Education:
- Bachelor's degree in life sciences, healthcare, or related field; clinical research certification is a plus.
Skills:
- Strong attention to detail and organizational abilities.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office Suite and clinical trial management systems (CTMS).
- Ability to work independently and collaboratively in a fast-paced environment.
Ideal Experience:
- Experience: 1-3 years in clinical research or a related field; previous experience with clinical trial documentation or administration preferred.
- Familiarity with GCP guidelines, ICH regulations, and regulatory submission processes.
Other attributes:
- Problem-solving skills and the ability to anticipate needs and manage multiple priorities.
- A team-oriented approach with a focus on quality, efficiency, and meeting deadlines.
- Confidentiality and professionalism in handling sensitive trial information
- Receptive to feedback and proactive
- Self-motivated, with a can-do-attitude and the ability to work both independently and as part of a team
