Clinical Trial Coordinator

Clinical Trial Coordinator

3month initial contract

8am-5pm

$30-$32/HR including health benefits

Chaska, MN

Orion Group is now seeking a Clinical Trial Coordinator to work onsite for our premiere medical device manufacturer in Chaska, MN.

The Clinical Trial Coordinator will report to the Sr. Manager of Clinical Affairs for Chemistry & Immunoassay businesses.

The Clinical Trial Coordinator (CTC) is responsible for providing administrative and operational support for the day-to-day execution of clinical trials.

The Clinical Trial Coordinator CTC will conduct routine duties associated with a study(s), supply management, payments, document tracking and filing, as well as assisting with the activities of the study team and associated vendors.

Clinical Trial Coordinator Responsibilities:

• Support clinical study team(s) as an expert in document management.
• Collect, review and file essential clinical trial documents; identify and track issues to resolution.
• Prepare, manage and archive clinical trial documentation in accordance with applicable regulations.
• Conduct quality checks of clinical trial documentation/files.
• Prepare shipments, maintain stock levels and manage tracking and reconciliation of study supplies.
• Assist with financial accruals, site and vendor payments, and maintenance of associated payment systems.
• Create and maintain internal study-specific tools (e.g., site lists, contact information).
• Manage the generation, translation, assembly and distribution of study materials.
• Support clinical trial sites directly/indirectly through assigned site managers, as needed.
• Generate and disseminate clinical trial correspondence including newsletters, global correspondence, etc.
• Handle confidential and proprietary information in accordance with applicable laws and regulations.
• Ensure optimal communication with internal and external partners specific to administrative tasks of the team.
• Proactively identify and resolve operational project issues and participate in process improvement initiatives as required.
• Provide general logistical support for clinical trials, such as creating agendas and taking minutes at meetings, and assisting with purchasing and/or budget activities.
• Works under the general guidance of Staff Clinical Scientist or assigned Clinical Study lead for the project to prepare deliverables for the internal and external activities for one or more assigned projects.
• May be asked to perform other clinical responsibilities as directed by the project or functional leader of Clinical Affairs.

Clinical Trial Coordinator Qualifications:

• Bachelor's degree in field with 2+ years of experience or a Master's degree with 0-2 years of experience.
• Flexible.
• At least 2-3 years supporting clinical trials in an administrative capacity.
• Working knowledge of Good Clinical Practice and FDA regulations.
• Excellent computer skills including proficiency in Microsoft office.
• Self-motivated, detailed oriented, and capable of working independently.
• Strong organization and time management skills; ability to work on multiple projects simultaneously.
• Must be detail-oriented; demonstrate excellent verbal/written communication and interpersonal skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.