Senior Clinical Project Specialist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Senior Clinical Project Specialist

Entry level position in Study Operations Project Management team. Participates in the execution of Abbott clinical device studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. Dedicated focus is on study management support activities which may include vendor oversight.

Essential Functions:

• Supports Clinical Project Manager in key study execution tasks
• Responsible for maintaining study specific SharePoint sites and study level TMF
• Develops and owns study-specific materials such as training slides, document templates (i.e. DoA, training logs), and newsletters.
• Assists with development of study-related materials such as: SIV slides, patient brochures, patient recruitment material, and presentations.
• Reviews Site Activation Checklist to ensure all required elements and documents are included.
• Assists with site selection processes.
• Coordinates activities with study specific committees, vendor services, and core labs.
• Reviews documents (e.g. study document templates and site activation regulatory documents) for accuracy and completeness.
• Provides periodic updates on site and/or study statuses, as requested by the Clinical Project Manager

• As applicable, communicate effectively with Customers/KOLs, Physician Members, National Principal Investigators, Field Clinical, Medical Directors, and Clinical Science, Research and Development, and other internal personnel.

Requirements:

Required:

• Bachelor's degree. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
• Minimum 3 years in clinical operations or healthcare related field. Medical training/background highly beneficial
• Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem-solving skills. Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.
• Proficiency in Microsoft Office Suite and relevant clinical applications.
• The ability to work independently when necessary.
• The ability to exchange straightforward information, ask questions, and check for understanding.

Desired:

• A general familiarity with cardiac, vascular technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
• Work habits include organization, coordination of many tasks, accuracy, and attention to detail.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.