Job Description

A medical device company is looking to hire a Clinical Research Specialist, onsite in Maple Grove, Minnesota. This direct hire employee will report to the Director of Clinical Operations and under their general supervision, will develop, coordinate, administer the logistical aspects of clinical trials according to GCP and SOPs. This person will act as a pivotal point of contact and communication between department staff, clinical sites, as well as vendors.

What You'll Do:

• Develops, tests, and implements clinical tools to provide relevant information for clinical studies management.
• Manages clinical study site information and documentation.
• Requests, tracks, reviews and assures receipt of proper study documentation (IRB approval letters, Signature Pages, Informed Consent materials, signed Clinical Study Agreements, Confidentiality Agreements, etc.).
• Obtains, reviews, and files site personnel documentation to ensure site compliance.
• Develops and distributes clinical study documents (Protocol, Case Report Forms, Informed Consent, Agreements, etc.).
• Routinely corresponds with clinical study sites.
• Promptly answers sites’ questions and requests with accuracy.
• Generates and submits memos and study documents (protocol amendments, newsletters, brochures, etc.) to clinical study sites.
• Generates, reviews, and responds, to queries
• Coordinates all information regarding reportable Serious Adverse Events and ensures all information is received by the internal team and clinical study sites.
• Manages payments for sites, data management groups, core laboratories, and Contract Research Organizations, as required.
• Maintains accurate records and files of study patient data.
• Coordinates accurate completion of Case Report Forms by timely reviewing Case Report Forms and corresponding with sites to update data and/or creating corrective action plans.
• Coordinates and performs data input and data verification from Case Report Forms retrieved from sites.
• Coordinates on-site and off-site Investigator, Study Coordinator and Technologist training meetings and conference calls.
• Orders, assembles, and maintains supplies of study materials and equipment (handbooks, Case Report Form books, IDE copies, medical equipment, etc.).
• Other duties, as assigned by supervisor. Takes work direction from the department head and/or clinical research project managers.

Must Have Skills:

• Bachelor’s degree in engineering, biology, physical sciences, nursing or another related field.
• One plus years of experience in clinical/medical affairs in the medical device industry
• Strong organizational skills and detail orientation required.
• Ability to handle multiple priorities in a fast-paced environment
• Interpersonal and communication skills necessary to interact with study site personnel and physicians
• Knowledge of medical terminology and anatomy.
• Knowledge of FDA guidelines and regulations governing conduct of clinical trials
• Analytical skills to determine clinical requirements and evaluate software solutions.
• Ability to make independent judgments.
• Intermediate skills in Microsoft Office, Word, and Power Point.
• Advanced skills in Excel, Access, and clinical database software.
• Ability to travel as needed up to 20% for site openings, trainings and conferences

Salary of $75K-$95K annually

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