Required Skills and Experience:

• Bachelor's Degree in a scientific or healthcare-related field or relevant experience
• Minimum of 3 years applicable experience required. Relevant experience may be a combination of related work experience and/or Master's degree obtained (Master's Degree = 2 years relevant experience).
• Proficiency in Microsoft Office and experience with EDC systems
• Excellent communication, organizational, and interpersonal skills

Essential Functions/Responsibilities (other duties may be assigned):

• Works under the direction of experienced project clinical trial managers to assist with day-to day operations of various research studies from trial start-up to database lock.
• Ordering and shipping of study supplies, working with the trial manager to provide supply cost estimates for study materials.
• Ensures adherence to federal or other regulatory requirements in accordance with ICH/GCP and SOPs.
• Coordinate teleconferences and team meetings, including agendas and other meeting materials.
• Assists in the development, implementation and coordination of study specific guidance documents.
• Coordinate all study specific training for the study team within electronic systems.
• Oversight of the Trial Master File (TMF), including management and coordination of the required TMF quality reviews.
• Under supervision, assists with development of study plans and provides overall project coordination, including progress tracking and reporting, quality control, recruitment and research support staff training.
• Coordinates all research project-related activities to assist the research team with meeting project goals and milestones, based on study design.
• Communicates resource needs, issues, project status and milestones met to project team and project leader.
• Assists with assigning access and maintaining electronic systems with up-to-date information.
• Develops and delivers study specific material such as tracking logs, templates, study binders, process manuals, etc.
• Submits requests for data extracts according to the study protocol and direction from the research investigator and project manager.