Clinical Trials Coordinator

Exciting opportunity for an experienced Clinical Trials Coordinator to join the team at Adaptive Phage Therapeutics, Inc. (APT). 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 individual will be expected to work on-site. The position will report to Director Clinical Operations.

Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform these 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 (e.g., 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.

Please note this job description is not an all-encompassing and comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Qualifications

• 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

Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.

*Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through the Adaptive Phage Therapeutics Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Adaptive Phage Therapeutics, and no fee/payment will be paid. Recruiters interested in working with Adaptive Phage Therapeutics can submit their information to hr@aphage.com and we will contact you if needed.