Clinical Research Coordinator II (CON)

AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.As a Clinical Research Coordinator, you will: (1) work closely with study leadership to satisfy applicable internal and external clinical and regulatory requirements for assigned clinical studies; (2) focus on tasks related to site document management and data collection; (3) work under direct supervision; and (4) develop alternatives and solutions for problems of limited scope and complexity. Document Management: Creates and manages study files. Creates and manages regulatory binder documents. Oversees the distribution of clinical study documents. Tracks site activation progress by ensuring receipt of proper study documentation, agreements, and site approvals. Identifies issues related to site readiness documents. Assists with periodic internal file reviews of clinical study files for completeness. Assists study team with critical study document finalization, such as contract amendments, informed consent revisions, etc. Study Material Accountability: Assists with study material tracking and accountability. Data Management: Completes second-pass data entry. Actively participates in the design of case report forms based on protocol requirements. Actively participates in the design and user acceptance testing of study management reports based on protocol requirements. Actively participates in user acceptance testing of study databases based on protocol requirements. Generates and reviews study management reports (DCFs, compliance reports, etc.). Reviews completed case report forms and DCFs. Assists with clinical report development (interim, final, regulatory, committee, etc.). May assist with training database administration. Interacts with site staff for data collection and follow-up. Compensation: Identifies and tracks site data compensation and other reimbursements (IRBs/ECs, etc.) depending on the needs of the assigned study. Meeting Coordination and Support: Assists with meeting planning and preparation for investigator and committee meetings. Infrastructure Development: Assists with training of new clinical team members. May contribute to ongoing project-specific process improvement efforts. May contribute to ongoing departmental process improvement efforts. Study Closure: Assists study team members with performing study closure activities. Other: Reviews study documents as requested. Supports overall management of project through effective self-management. May provide input into study budget and schedule. Assists with monitoring tasks, such as regulatory file reviews and preparation, as appropriate for the assigned study. Qualifications: Bachelors degree required, health sciences or related field preferred. One plus years of clinical research experience preferred. Computer proficiency with Microsoft Office required. Data entry experience required. ClinDex data entry experience preferred. -For quick consideration apply here We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more. An Equal Opportunity/ Affirmative Action Employer Please, No Agencies Position Information Location: Plymouth, MN Job Category: Biotech/R&D/Science Contact Information reference code: 1189