Study Start-up Assistant

Study Start-up Assistant

The Study Start-up Assistant performs a variety of supportive start-up activities integral to the successful start-up process at AMR Clinical research sites. The Study Start-up Assistant is responsible for performing tasks assigned by the Study Start-up Lead and Study Start-up Manager. The Study Start-up Assistant will perform these tasks to ensure an efficient study start-up process.

To Consistently Embody AMR Clinical’s Core Values:

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

Primary Responsibilities

• Submit Recruitment Materials to the IRB and notify the Study Start-up Lead when they are completed.
• Maintain consistent communication with the Study Start-up Lead and Study Start-up Manager on task progress for all studies in start-up.
• Precise completion of start-up regulatory documents, including but not limited to Financial Disclosure Forms (FDF’s), Data Privacy Consent Forms, and 1572’s.
• Promptly route applicable documents in eISF System (Veeva or Complion) to site staff.
• Enter data into applicable AMR Clinical Systems, including but not limited to Clinical Conductor, One Home, and Excel start-up trackers.
• Create and/or update AMR Clinical Staff CVs.
• Complete start-up eISF filing, ensuring consistency and quality across all AMR Clinical sites.
• Promptly communicate any issues to Study Start-up Lead and Study Start-up Manager.
• Perform all start-up activities in accordance with federal Food and Drug Administration (FDA) regulations and guidelines to ensure compliance with federal law.
• Provide quality service to internal and external teams in a timely manner, whether in person, by phone or email.
• Complete various projects for study start-up, as needed.
• Other duties as assigned.

Desired Skills And Qualifications

• 1 year professional office experience required.
• Willingness to work in a fast-paced environment where processes change and improve continually.
• Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach.
• Ability to effectively devote keen and acute attention to detail.
• Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Outlook, Internet.
• Professional and highly motivated “self-starter” with the ability to exercise initiative.
• Excellent task management and prioritization skills.
• Strong written, verbal and interpersonal skills.
• Excellent follow up.
• Fluent in English.

AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Key skills/competency

• Study Start-up Assistant
• IRB Submission
• Regulatory Documents
• eISF System
• Clinical Research
• Data Entry
• CV Creation
• FDA Regulations
• Attention to Detail
• Task Management