Title: Clinical Research Specialist / Clinical Safety Specialist
Remote: Fully remote candidates considered (EMEA based candidates are open for this role)
Hours: 32- 40 hours
Duration: 24 months
Description:
- Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).
- Conduct Case Management in the Clinical Safety Database.
- Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.
- Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies).
- Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
- Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centres for protocol(s).
- Liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
- Write Clinical Safety plan for assigned protocol(s).
- Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.
- Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
- Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.
- Performs other duties as assigned.
BASIC QUALIFICATIONS:
- Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
- Proficient with MS Office products, word processing, spreadsheets, etc.
- High attention to detail and accuracy and ability to manage multiple tasks.
- Good prioritization and organizational skills.
- Excellent problem-solving skills.
- Flexible and dependable.
- Works effectively on cross-functional teams.
EDUCATION REQUIRED:
- Bachelor?s degree
YEARS OF EXPERIENCE
- 2+ years safety experience (preferred)
SPECIALIZED KNOWLEDGE REQUIRED
- Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
- Affinity for data: logic statements, data visualization
- Fluent with medical terminology
DESIRED/PREFERRED QUALIFICATIONS (optional)
- Health professionals including Biomedical Engineer, Biomedical Scientist, RN, PA (Interested in biomedical engineers, RNs (BSNs), paramedics, etc.)
- Experience with Business intelligence tools (Spotfire, Business Objects, Power BI, etc.) and SharePoint environments
- While Cardiac experience would be nice, we don?t need any clinical trial experience (Exposure to clinical trials and cardiac experience is a plus)
Nice to Have's
- Medical background (biomedical engineer, allied health professional, nursing, etc.)
Good to Have's
- Top three skills: Experience with Excel/logic statements, previous Safety experience would be a plus, proactive. Affinity for data: logic statements, data visualization
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: RU-119-2
Website: Achieva Group Limited
- Posted: 5th January 2023
- Expires: 2nd February 2023
