Job Title: Clinical Data Coordinator
Location: Maple Grove, MN
Duration: 6+ Month W2 Contract
Pay: $36k - 40k/year
Job Summary: Oversee data management activities for clinical studies, ensuring the integrity of study data by entering, reviewing, modifying, reconciling, and organizing data. This role requires working onsite and involves testing and verifying clinical data management systems, managing discrepancies, and complying with FDA regulations.
Key Responsibilities:
- Data Management:
- Develop and maintain Case Report Forms and Edit Check specifications
- Create and update Data Management Plans
- Perform data quality checks and manage discrepancies (creating, routing, and resolving)
- Analyze data and prepare reports, with intermediate-level knowledge of Excel functions such as pivot tables, search functions, and XLOOKUP
- Test database setups and Edit Check programming
- Handle external data and device reconciliation
- Participate in Post Market Surveillance reporting as needed
- Ensure compliance with FDA regulations, ICH guidelines, ISO 14155, and company policies
- Potential for occasional overtime
Qualifications:
- Minimum of 2 years in a comparable or closely related clinical research environment. 1 year of experience may be considered if all other requirements are met. Medical device experience is a plus.
- Proficiency in computer skills, including Excel (pivot tables, search functions, XLOOKUP)
- Ability to manage multiple projects
- Experience with clinical databases (Oracle preferred but not required)
