Clinical Trial Administrator: Study Coordination & Compliance

Coloplast; Minneapolis (MN); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Kerecis in Minneapolis seeks a Clinical Trial Administrator to support daily trial activities, prepare and maintain trial documents, and coordinate with Clinical Research Associates.

The role involves ethics submissions, site communications, and invoice processing with travel <5%. Strong English, organizational skills and clinical study experience are required; a Bachelor’s degree is preferred.

Qualifications

• One year of experience as a clinical research coordinator.
• Experience with device or pharmacology trials or clinical studies.
• Very good knowledge of English (verbal and written).
• Conscientiousness, precision and consistency in tasks.
• High interpersonal and teamwork skills.
• Ability to work with a large team and manage multiple tasks.
• Motivation and commitment to the role.
• Strong organizational skills and time management.
• Experience processing payments / invoices through accounting.
• Openness to new challenges and willingness to improve skills.
• Knowledge of ICH GCP is a plus.
• Good knowledge of Microsoft Office.

Responsibilities

• Assist in the preparation and maintenance of trial documentation.
• Submit clinical trials to ethics committees.
• Cooperate with Clinical Trials Monitors.
• Participate in Clinical Trials team meetings.
• Conduct correspondence with study sites and phone contact.
• Report ongoing progress to project managers.
• Maintain and report identified metrics and study materials.
• Prepare study binders, enrollment logs, and accountability logs.
• Submit required forms and update study documents.
• Establish and organize study files and regulatory binders.
• Assist principal investigator/site communication.
• Weekly calls to study centers for shipment coordination.
• Document site recruitment and patient status; upload to SharePoint.
• Prepare monthly progress updates for meetings and Clinical Newsletter.
• Prepare agendas and take notes for Clinical Development meetings.
• Serve as Administrative Secretary of Trial Council.
• Submit vendor invoices and POs; ensure Net 30 terms.
• Compile study binders for sites and ship as needed.
• Track and file study documentation; label materials for shipment.
• Request study materials and facilitate shipments.
• Anticipated travel <5%.
• Adhere to ethics standards and company policies.
• Other duties as assigned.

Skills

English proficiency

Time management

Organizational skills

Interpersonal skills

Team collaboration

Communication

Education

Bachelor's degree in science-related field

Tools

Microsoft Office

SharePoint

Job description

Kerecis in Minneapolis seeks a Clinical Trial Administrator to support daily trial activities, prepare and maintain trial documents, and coordinate with Clinical Research Associates.

The role involves ethics submissions, site communications, and invoice processing with travel <5%. Strong English, organizational skills and clinical study experience are required; a Bachelor’s degree is preferred.