Clinical Research Associate

Position Overview

The Clinical Research Associate will play a crucial role in facilitating Abbott's clinical studies at designated sites, specifically in Maple Grove, MN. This contract role spans eight months with a strong possibility of extension. The individual will be integral in ensuring timely site initiation, adherence to protocols, and compliance with regulatory and Good Clinical Practices across all study phases.

Key Responsibilities

• Support activation, maintenance, and close-out procedures of clinical trial sites collaboratively with Abbott's internal teams and external site staff.
• Ensure that the study sites comply with all clinical protocols, regulatory requirements, and Abbott's internal standard operating procedures.
• Review informed consent forms to confirm inclusion of all necessary elements.
• Analyze and verify study data and regulatory documentation for completeness and accuracy while aiding in data query resolutions.
• Manage follow-up activities related to monitoring visits and audits, escalating concerns as needed.
• Serve as the primary point of contact for assigned clinical trial sites, liaising between site personnel and clinical management teams.
• Utilize clinical research knowledge to aid in process improvements and support training of external clinical staff to ensure adherence to study guidelines.
• Maintain up-to-date internal trial documentation and trial master files to support study management.
• Help collect and sustain study-specific communications to streamline study activation and execution.
• Potentially contribute to regional and global improvements in clinical trial processes.

Qualifications and Skills

• A Bachelor's degree with preference in natural sciences, pre-medicine, nursing, bioengineering, or an equivalent blend of education and experience, with at least two years of relevant experience.
• Experienced in Microsoft Office Suite with strong communication, presentation, organizational, interpersonal, and analytical skills.
• Ability to interpret fundamental clinical data effectively and meet deadlines independently while asking for guidance when required.
• Familiarity with clinical trial research processes is advantageous.
• Previous clinical or research experience in a hospital or corporate clinical setting is preferred.
• Certification by recognized professional bodies such as SoCRA or ACRP is desirable.
• Demonstrated work habits including organization, attention to detail, task coordination, and accuracy.

Additional Information

Candidates are expected to keep abreast of current clinical regulations and industry best practices, be engaged with professional societies, and pursue ongoing education about Abbott's medical devices and therapies.