Clinical Trial Associate - Remote

Overview

DiaMedica Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments where there is a significant unmet clinical need or where no current therapies are available. We are committed to improving the lives of people suffering from preeclampsia and acute ischemic stroke and we are currently advancing our lead candidate, DM199, through the clinical development process.

In Short

• Provide administrative support to Clinical Operations team members in the execution of clinical trials
• Assist with the collection, organization, and filing of essential clinical trial documents in the electronic Trial Master File (eTMF)
• Track and maintain study-related documentation, including regulatory documents, training records, and site activation materials
• Support the coordination and documentation of protocol deviations, site issues, and trip report reviews under direction of the Clinical Trial Manager
• Schedule meetings, prepare and distribute agendas, capture meeting minutes and action items for internal and external project meetings
• Assist in the management of study to ensure adherence to timelines and achievement of study goals while ensuring high quality
• Identify clinical study and investigative site risks and propose corrective actions, where applicable
• Coordinate the logistical aspects of investigator meetings, site trainings, and other key study meetings throughout the trial, including meeting materials and attendance tracking
• Assist in the development of critical study documents
• Provide oversight of activities related to safety reporting compliance

Requirements

• Bachelor's degree is required; scientific/health care field preferred, but not required
• Minimum of 2 years’ experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor)
• Strong skills in collaboration, communication, organization, attention to detail and multi-tasking
• Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency
• Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred
• Must be comfortable working in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands

Benefits

• Diverse work environment
• Equal employment opportunity