Consistent with its founding motto, "No research without therapeutic or policy benefit," New England Research Institutes (NERI) strongly encourages its scientists to implement innovative designs using multi-method approaches and to try new strategies for disseminating results.
The Clinical Safety Specialist is responsible for general safety and compliance oversight on clinical studies. The safety specialist is involved in the scientific conduct of clinical trials to guarantee the release of high quality data.
The Clinical Safety Specialist will review and triage adverse events (AEs) including serious adverse events (SAEs) reported by Sites as a part of clinical trials
Codes adverse events, using MedDRA, where directed by the governing process. Drafts AE narratives as required, for inclusion in reports or regulatory submissions.
Reviews SAE for administrative and medical consistency with other site-reported data; including requesting follow-up and clarification from Sites
Prepares adjudication event dossiers for CEC review
Collaborates with team members in preparation for and potential attendance at DSMB/CEC meetings.
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).
Liaison for safety related questions (e.g. to study team, monitors and study sites)
Write clinical safety plans or safety management plans for assigned protocol(s).
Assist 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.
Maintains knowledge of current FDA, ICH and ISO regulatory rules and polices affecting clinical trials.
Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to ensure compliance and accurate reporting.
Performs other duties as assigned.
Bachelor's degree in a life sciences area or RN. BSN preferred.
MedDRA certification preferred
Strong understanding of adverse events, clinical sequelae, and risk assessment.
Minimum of 2+ years of hands-on related safety experience in a clinical trial environment.
Proficiency in Microsoft Office applications as well as MedDRA coding experience.
Strong knowledge and competence in application of CFRs, GCPs and ICH Guidelines required. FDA audit experience is a plus.
Excellent verbal and written communication skills and ability to interact effectively in a team environment.
Highly organized, self directed and demonstrates a consistent attention to detail.
Ability to prioritize, plan and organize work assignments while working under strict timelines.
Must demonstrate accountability for delivery of results and have good problem solving skills as well as decision making ability.
This is an exciting opportunity to work within an internationally recognized public health research organization, collaborate with leading research scientists and contribute to meaningful, mission driven projects.
NERI is an Equal Opportunity/Affirmative Action Employer