Contract Clinical Research Assistant (3 to 6 months)

Summary Of Essential Duties And Responsibilities

• Perform quality checks, uploads and tracking of required regulatory documents to populate the electronic Trial Master File (TMF) for designated studies.
• Generate reports of missing documents and upcoming expiration dates.
• Communicate with sites and/or study team to obtain required documents.
• Ensure the TMF is audit-ready in support of regulatory filings.
• Track and ensure study-related images are obtained from sites and provided to Core Labs for analysis in a timely manner.
• Aid in providing feedback to sites as needed.
• Obtain safety-related source documents from clinical sites in preparation for Clinical Event Committee and Data Safety Monitoring Board meeting packages.
• Work with translation vendors as needed.
• Track device inventory and prepare shipments to sites, ensuring device integrity is maintained (i.e., temperature control and expiration dates).
• Process returned/expired devices.
• Aid in the distribution and tracking of clinical study supplies to Contract Research Organizations (CROs) and clinical centers (e.g., study binders, case report form worksheets, study devices and misc. materials).
• Interface with CROs to obtain study-related documentation and follow up on action items.
• Aid in site invoicing and payment tracking.
• Aid in the organization and filing of study related materials.
• Aid in the organization and execution of Investigator meetings.
• Aid in processing and tracking of study related costs.
• Provide general administrative support as needed.

Education And/or Experience

• Undergraduate degree
• 2-3 years of relevant clinical trial experience

Required Knowledge/Skills

• Minimum of 1-2 years of clinical study electronic Trial Master File experience
• Proficient with basic computer programs such as Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• Detail oriented in document review and error checking
• Effective communication skills

Desired Knowledge/Skills

• Minimum of 1-2 years of Sponsor or CRO experience
• Working knowledge of CDISC TMF Reference Model

Physical Demands/Working Environment

• Frequent sitting or standing for prolonged periods of time, frequently in front of a computer.

Pay

$25.00 - $30.00 per hour