Responsibilities: 

The CRM I assists in the management of one or more clinical studies, partnered with a clinical trials assistant, through the following activities, all under appropriate supervision:

• Assisting in the coordination of cross-functional study teams through communications with clinical sites, sponsors, and vendors
• Contributing to protocol development by drafting operational protocol sections, ensuring consistency throughout the document, coordinating reviews, and ensuring compliance with regulatory authorities
• Assisting in the preparation, submission, and tracking of IRB materials
• Developing and coordinating team review of training materials, procedural manuals, and other materials; tracking training completion
• Facilitating and delivering components of study-specific training
• Providing technical assistance and supporting clinical sites through:
  • Tracking site activation and performance, which may include study accrual, timelines, and close-out
  • Identifying and communicating potential problems
  • Working with sites post monitoring visit(s) on action items
• Facilitating team meetings/calls including:
  • Writing and/or reviewing meeting minutes
  • Ensuring key decisions are documented
  • Tracking action items to resolution
• Maintaining study files including:
  • Setting up and maintaining shared filing systems (e.g., SharePoint, MS Teams)
  • Developing and maintaining tracking tools (e.g., Excel/Word document tracker, study timeline)
  • Collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF])
  • Contributing to the study specific eTMF Management Plan
• Drafting, reviewing, providing input on and/or finalizing documents, such as study progress reports and/or IDCRC specific work instructions.
• Assisting Working Groups and Committees with meeting coordination, reviews, and other operations
• Coordinating reviews of and providing input on abstracts, presentations, manuscripts, final study reports
• Performing other duties as assigned

Supervision Given/Received:

• Receives general instructions on routine work, and detailed instructions on new projects or assignments
• Mentors Clinical Trials Assistants (CTA)
• Does not have direct report/supervision responsibilities

Requirements:

• Bachelor’s degree or its international equivalent in clinical research, health, behavioral, life or social sciences, or other related fields. Master’s degree preferred.
• Minimum of 2 years of experience in clinical research, or other research or healthcare-related field.
• Basic knowledge of the conduct of clinical trials, related systems, and procedure.
• Strong understanding of applicable clinical research regulatory requirements, e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and FDA regulations, to maintain site(s) essential regulatory documents per sponsor requirements.
• Ability to work independently and in a cross-cultural team and geographically diverse environment.
• Ability to prioritize and multitask, proactively follow up, effectively manage time, assess, meet and/or adapt to changing priorities and deadlines effectively, with strong attention to detail.
• Proficiency in Microsoft Office 365 (i.e., Word, Excel, PowerPoint, Outlook, Teams) and familiarity with webinar platforms, such as Zoom.
• Articulate, professional, and able to communicate in a clear, positive fashion with external partners and staff.
• Ability to write clearly and succinctly; must be able to synthesize and summarize information.
• Must be able to read, write, and speak proficient English.