Clinical Trials Associate I - IMPAACT Network

Job Summary:

Accountabilities:

• Supports clinical teams by performing tasks related to study management from start up to study completion.
• Provides administrative support to the project team.
• Assists the clinical project management team with written and verbal communications with study staff and sites.
• Assists the clinical project management team with the creation of study-specific documents and materials, and with the acquisition of study supplies.
• Utilizes technology effectively to support clinical development processes; develops mastery of relevant systems (e.g. study management tools) and identifies new innovative ideas and shares best practices.
• Prepares and issues meeting minutes, including action items, under the direction of project management.
• Maintains the study-specific TMF and associated electronic archives.
• Assists the clinical project management team with the organization of meetings.
• Support the clinical operations teams with ongoing conduct of studies.
• Assists in the close-out of projects by performing a final Quality Control (QC) of the TMF, identifying items and issues for review and/or follow-up by the CRAs and/or project management.
• Assist in the production of slides, overheads, etc. as needed for department, project, and sponsor and or business development.
• Performs other duties as assigned.

Applied Knowledge & Skills:

• Needs a basic understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
• Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items.
• Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
• Ability to prioritize and manage multiple tasks.
• Familiar with applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Proficiency in Microsoft Office, spreadsheet software and other technology required.
• Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
• Demonstrated effective organizational skills.
• Demonstrated strong attention to detail.
• Must be able to read, write and speak fluent English.

Problem Solving & Impact:

• Works on problems of limited scope that require a review of various factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Decisions generally affect own job or specific functional area.

Supervision Given/Received:

• Receives general instructions on routine work, detailed instructions on new projects or assignments.
• Does not have direct supervision responsibilities.
• Typically reports to a Manager/Associate Director.

Education:

• High School/GED Diploma or its International Equivalent in Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
• Bachelor's Degree preferred.

Experience:

• Typically requires a minimum of 0 - 3 years’ experience in clinical research, other research or health care related field.
• Related prior work experience preferred. Prior work in a non-governmental organization (NGO).
• Non-governmental organization (NGO) experience preferred.

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit and stand for extended periods of time.
• Ability to lift 5 - 50 lbs.

Technology to be Used:

• Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, e-mail), office telephone, cell phone and printer/copier.

Travel Requirements:

• Less than 10%