Clinical Research Associate

Job Description

Title: Clinical Research Associate

Location:  Plymouth, MN

Start date: January 2022


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 Research Associate will support clinical research activities associated with the clinical research sites that are participating in DiaMedica clinical trials. The Clinical Research Associate (CRA) will assist with site selection, start-up activities overall study execution and monitor sites for study adherence.

Essential Duties and Responsibilities:
  • Oversees all aspects of study site management for clinical studies according to DiaMedica Standard Operating Procedures (SOPs), ICH-GCP and local regulations and to ensure data are up to date per reporting metrics, query resolution, data entry Involved in recruitment of potential Investigators and sites for DiaMedica studies
  • Develops and maintains strong working relationship with Investigators and study staff, serving as an ambassador to promote DiaMedica Therapeutics high quality and ethical image
    • Communicates effectively with site personnel, including the Principal Investigator (PI), to troubleshoot and provide appropriate solutions to study-related issues, as appropriate
    • Prepares Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submission package, notifications to regulatory authorities, and translation of study related documents
    • Organizes meetings and other tasks as directed
    • Performs site qualification and initiation visits: trains Investigators and other trial staff on the protocol and data collection methods to ensure collection of participant data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and DiaMedica SOPs
    • Provide relevant, timely study subject updates to the study team (e.g., upcoming enrollment dates, subject withdrawals, etc.)
    • Maintains study tracking, in accordance with the demands of the study
    • Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, participants' safety, rights and wellbeing are protected and investigational product/biological samples/supplies accountability
  • Professional Experience / Skills:
    • Bachelor’s degree (or higher) health sciences or related field
    • Research experience, minimum of two years as a CRA with clinical site monitoring experience
    • Good understanding of FDA CFR (clinical trials); GCPs and ICH Guidance
    • Communication skills: Strong oral and written
    • Work independently and under general supervision
    • Proven organizational skills and the ability to manage multiple priorities
    • Strong computer skills—proficient in Microsoft Office applications, Word, Excel, SharePoint
    • Travel; Ability to travel with adequate prior notification approximately 60% during peak periods
    • ACP or SoCRA certification preferred

Job Type: Full-time, based in Minnesota (M-W in office, T, Th, Fri remote)

Work Location: Plymouth MN