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Job Title: Clinical Research Associate I/II Immediate Supervisor: Chief Medical Officer

Grade Level / Status Job Type Work Location Last Revision Date
Salaried - Exempt Full-time Plymouth, MN 09/23/19

Primary Function

The Clinical Research Associate will support overall clinical research activities by working directly with the staff at the clinical trial sites. The Clinical Research Associate (CRA) will also assist with site selection, start-up activities, laboratory services, and other 3rd party vendors as required for site participation in the clinical trial.

Major Responsibilities

· Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the Trial Manager

· Assist with the negotiates site and/or investigator budgets and with the execution of site contracts with support from the legal department

· Responsible for overseeing and administering investigator site activities for clinical studies according to DiaMedica Standard Operating Procedures (SOPs), ICH-GCP and local regulations

· 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

· Oversees all aspects of study site management and data capture to ensure consistently low query levels and good Quality Assurance reports

· Provide relevant, timely study participant updates to the study team (e.g., upcoming enrollment dates, participant 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, the protection of participants' safety, rights and wellbeing and investigational product/biological samples/supplies accountability

· Communicates effectively with site personnel, including the Principal Investigator, study coordinator and staff as required to troubleshoot and provide appropriate solutions to study-related issues, as appropriate

· Develops and maintains strong working relationship with Investigators and study staff, serving as an ambassador to promote DiaMedica Therapeutics’ image as a high quality and ethical organization

· Other duties as assigned

Qualification Requirements

· Bachelor’s degree (or higher) in nursing, health sciences or related field

· Minimum of two years of CRA experience, with clinical site monitoring experience preferred

· Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance

· Self-motivated and high degree of task ownership

· Strong oral and written communication skills

· Strong interpersonal skills with demonstrated ability to wide range of individuals, e.g. individuals with various levels of technical training.

· Ability to work independently

· Proven organizational skills and the ability to manage multiple priorities

· Demonstrated ability to work productively in a team environment

· Strong computer skills

· Ability to travel with adequate prior notification approximately up to 40% during peak periods

Work Environment

This position resides within a normal office working environment with very little travel required.