Our client is a clinical state biotechnology company focused on developing innovative therapies addressing the global crisis of antiobiotic-resistant bacterial infections. They have a learning focused culture where individuals can take ownership and cross-train in different areas. 

This Clinical Trials Specialist 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 individual will be expected to work on-site.The position will report to Director Clinical Operations.

Essential Functions

• Create and review site feasibility assessments required for study participation.
• Assist in the development of all study related documents, including but not limited to study protocols, informed consent documents, study manuals and plans, site procedures manual, case report form design, monitoring plan, patient diaries, etc.
• Assist in the logistics of IP supply management and clinical lab sample shipment.
• Manage and track key study milestones such as screening, enrollment, protocol deviations, biological sample shipments, testing and data reporting.
• Assist in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.
• Coordinate, track and maintain documentation for temperature controlled shipments of biological samples collected at clinical sites for testing.
• Receive shipments of biological samples reconciling against manifest and database.
• Assist in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
• Coordinate and track site correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team.
• Participate in the development, review and implementation of departmental SOPs and processes.
• Update clinicaltrials.gov as needed.
• Other duties as assigned.

Job Requirements

• Bachelor’s degree in nursing, science or health related field required with at least 3 years of clinical research experience.
• Proficient in Microsoft office (Word, Excel, Project, Power Point)
• Excellent verbal and written communication skills
• Local Candidates preferred