Clinical Safety Specialist
- Achieva Group Ltd
- €30 - €40 per hour
- Start date
- 5 Jan 2023
- Closing date
- 4 Feb 2023
- Clinical Research, Clinical Research Associate
- Full Time
- Contract Type
- Experience Level
- Experienced (non-manager)
Remote: Fully remote candidates considered (EMEA based candidates are open for this role)
Hours: 32- 40 hours
Duration: 24 months
- 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.
- 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.
- Bachelor’s degree
- 2+ years safety experience (preferred)
- 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
- 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)
- 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 firstname.lastname@example.org
ACHIEVA is an experienced head on new shoulders.
ACHIEVA comprises five respected specialist recruitment businesses*1, joining forces to become one stronger and more powerful entity, bolstered by research, development and environmental enterprises that share our core values.
We have over three decades of experience in sourcing industry experts across a wide range of specialist sectors including Pharmaceuticals, Primary Care, Occupational Health, Health & Safety, Engineering, Development and Research.
Businesses are people powered. Now more than ever, they want resourceful, motivated and dynamic individuals who have the ability to thrive during times of change as well as the ability to weather any storm. ACHIEVA will find these people and will place them in environments where they will flourish.
ACHIEVA is born out of a recognition that the workplace is evolving and that with change, comes great opportunity. Opportunity for our clients and for our candidates.
ACHIEVA. It’s in the name.
- 01727 811634
22-24 Upper Marlborough Rd
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