Clinical Research Administrative Assistant

We are seeking a highly organized and detail-oriented Clinical Research Administrative Assistant to support our Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams. The successful candidate will be responsible for assisting with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports. They will also participate in the periodic review of study files for completeness and assist with the coordination of tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.

Responsibilities:

• Assist CRAs and RSU team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Participate in periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Coordinate the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications:

• High School Diploma or equivalent required.
• 3-4 years administrative support experience.
• Minimum one year clinical research experience strongly preferred.
• Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Basic knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Benefits: IQVIA is an equal opportunity employer and is committed to creating a diverse and inclusive environment. We offer accommodations for applicants with disabilities and encourage candidates to disclose any needs during the recruitment process.