Summary of Position
This individual will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, Trial Master File management and reconciliation, tracking of lab samples and investigational product as well as clinical quality oversight.. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to Director Clinical Operations.
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manger (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- Creates and reviews site feasibility assessments required for study participation.
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
- Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.
- Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team.
- Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
- Participates in the development, review and implementation of departmental SOPs and processes.
- Other duties as assigned.
Job Requirements (Essential knowledge, skills and attributes)
- Bachelor’s degree in nursing, science or health related field required with at least 3 years of clinical research experience. Clinical trial experience with vaccines, infectious diseases or hepatology indications a plus.
Altimmune is an equal opportunity employer that values diversity
Email your cover letter and resume or CV to:
Please reference Position Req#17-100
Posted on June 7, 2017