Clinical Research Specialist

Job Description

Location: Plymouth, MN

Start date: August 2021


DiaMedica Therapeutics is committed to improving the lives of people suffering serious diseases with initial focus on acute ischemic stroke (AIS) and chronic kidney disease (CKD). We have manufactured, patented and in licensed technology for the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, for the treatment of AIS and CKD.

The Clinical Operations team is seeking a collaborative and thoughtful Clinical Research Specialist to administer, maintain and coordinate the logistical aspects of clinical trials at DiaMedica Therapeutics. The CRS position is focused on providing support during clinical study planning and execution to include: development and maintenance of timelines, budgets, and various study plans. The incumbent maintains focus on intended timelines and achievement of study goals while ensuring quality in accordance with FDA, GCP, and ICH guidelines.

Essential Duties and Responsibilities:

  • Collaborate with Clinical Operations team members to assist in clinical trial management tasks (e.g. trip report review, issue tracking, and protocol deviation review)
  • Acts as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the TMF; reviews TMF documents as part of the Quality Review Process; acts as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to always ensure inspection-readiness
  • Obtains and disseminates schedules and calendars; prepares and distributes agenda and minutes and action items for project team meetings and client meetings
  • Interact with CROs and other clinical vendors to ensure deliverables are met and communication is efficient
  • Provide input during clinical study budget(s) reconciliation
  • Assist in the development of critical study documents
  • Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
  • Manages insurance certificate requirements
  • Provide input of activities related to safety reporting compliance
  • Reviews and maintains study-level training documentation
  • Reviews study-specific essential regulatory document packets prior to site activations
  • Coordinate the logistical aspects of investigator meetings
  • Partner with clinical site staff to ensure optimal Sponsor-Site relationships
  • Assist in the management of study to ensure adherence to timelines and achievement of study goals while ensuring high quality

Professional Experience / Skills:

  • 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
  • Proficient in Microsoft office applications (Word, Xcel, SharePoint)
  • 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

EEOC Statement:

DiaMedica Therapeutics Inc. believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.