Senior Clinical Trials Assistant (IDCRC)

The Infectious Disease Clinical Research Consortium (IDCRC) is an NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases. 
   
FHI 360 has partnered with Emory University to participate in leadership activities and serve as the Protocol Management Center for IDCRC driven research, leading study development and implementation funded by the Division of Microbiology and Infectious Diseases of the U.S. National Institute of Allergy and Infectious Diseases.  

The Senior Clinical Trials Assistant (CTA II) performs clinical research development activities with senior research staff for the IDCRC and assists in development, implementation, and oversight of IDCRC multi-site clinical research studies (from protocol development through study closeout). The CTA II closely observes, evaluates and reports on study progress and site operations through study tracking, data management reports, and monitoring follow up.  

The primary role of the CTA II is to assist clinical research teams by developing study specific documents, creating and maintaining filing and tracking systems to coordinate study progress, drafting and issuing meeting minutes, and facilitating communication. All activities are performed under supervision of senior staff. 

Responsibilities: 

Supports clinical research teams by performing tasks related to study management from protocol development and study start up, to study completion and publications, such as: 

• Maintaining shared filing systems (e.g., SharePoint, MS Teams); collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF]) 

• Developing and maintaining systems to coordinate and track study activation, study conduct, site performance, and timelines 

• Assisting with the preparation, submission and/or tracking of regulatory materials 

• Reviewing study documents, operational policies, and procedures; coordinating internal and external reviews; and tracking key decisions 

• Communicating directly with one or more research sites, providing technical assistance to research sites and study staff, including review of materials, site updates, and query resolution, under supervision 

• Assisting with study monitoring activities, including Quality Control (QC) of the eTMF and identifying issues for review 

• Provides overall administrative support to the clinical research team, such as: 

• Drafting and issuing meeting minutes, including action items and decisions under supervision; tracks action items to resolution 

• Developing and maintaining email alias lists 

• Scheduling conference and video calls and providing technical management 

• Assisting in the coordination of meetings, conferences, and trainings 

• Performs other duties as assigned 

Requirements:  

• Associate degree or its international equivalent in clinical research, health, behavioral, life or social sciences or other related field; Bachelor’s degree preferred 

• 0-3 years of experience in research or healthcare-related fields; previous work experience in clinical research is strongly preferred 

• Familiarity with applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines) is preferred.

• Ability to write clearly and succinctly, able to synthesize and summarize information; must be able to accurately record meeting minutes and document action items and decisions. Knowledge of medical terminology is preferred.  

• Strong interpersonal skills and ability to communicate in a professional, clear and positive fashion 

•  Ability to work independently and in a cross-cultural team and geographically diverse environment 

• Ability to prioritize and multitask, proactively follow-up on tasks, effectively manage time, assess, meet and/or adapt to changing priorities and deadlines effectively 

• Proficiency in Microsoft Office 365 (i.e., Word, Excel, PowerPoint, Outlook, Teams) 

• Demonstrated effective organizational skills 

• Demonstrated strong attention to detail 

• Must be able to read, write and speak fluent English 

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 o