We are looking to connect with experienced professionals who can support our Clinical Studies of Intimate Care and Personal Care Products on a flexible basis. Flexibility and the ability to work around evolving study schedules are important.
- Acting as the nominated Principal Investigator or Medical Investigator for intimate care, personal care and women’s health-related studies, where required by the study design, sponsor requirements or applicable regulatory expectations. This may include specialist clinical oversight, review of adverse events or clinically significant findings, participant safety considerations, and approval/signature of study documentation where appropriate.
- Reviewing study protocols, amendments and relevant study documentation.
- Reviewing, approving and signing study reports or documentation where professional gynaecological oversight is required, and "approval" claims will be made.
- Providing specialist gynaecological oversight for studies involving intimate care products, feminine hygiene products, personal care products or related cosmetic products.
- Conducting or overseeing protocol-specified intimate health or gynaecological assessments at agreed study timepoints.
- Recording clinical observations and assessment outcomes accurately.
- Advising on participant suitability, intimate health considerations and clinically relevant findings.
- Reviewing and interpreting clinically relevant findings, including irritation, discomfort, tenderness, redness, abnormal symptoms or other intimate health observations.
- Where required for study conduct and participant safety, providing appropriate specialist medical input regarding the availability, prescribing, authorisation, administration or oversight of prescription-only medicines and emergency medications, including anaphylaxis arrangements. This must be undertaken only where within the consultant’s professional scope of practice, legal authority, training and agreed study/site procedures, including any applicable requirements for controlled drugs.
- Reviewing and management of deviations, adverse events or clinically significant findings or participant-reported symptoms and advising on appropriate follow-up or escalation.
- Providing expert consultancy on equipment, room layout and study procedures, particularly given increasing requirements relating to decontamination and clinical environments.
- Providing advice on appropriate gynaecological instruments, equipment and any requirements associated with study conduction area.
- Maintain current professional competence, registration, training and knowledge within their field of expertise, including relevant gynaecology, women’s health, intimate care, participant safety, clinical research, ethical practice and professional standards.
- Working with the Eurofins Alba clinical team to ensure studies are conducted to appropriate ethical, quality and safety standards.
- Undertaking any other consultant duties commensurate with the nature and responsibility of the role as reasonably required.