Permanent and Fixed Term positions available
Due to the nature of the role, which involves administering treatments to female participants on a one-to-one basis in a private clinical setting, and to protect participant privacy and dignity, this position is subject to a Genuine Occupational Requirement under Schedule 9 of the Equality Act 2010 for the postholder to be female.
Overall Job Purpose:
1.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.
2.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.
3.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:
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
