Clinical Trial Assistant
Nucleix
Nucleix Ltd. develops, manufactures, and brings innovative non-invasive cancer molecular diagnostics tests to market. The company’s EpiCheck® core technology combines robust and highly-sensitive biochemistries with sophisticated algorithms to detect subtle cancer-specific changes in DNA methylation patterns and deliver excellent clinical performance. Bladder EpiCheck® is the company’s first on-market urine test for monitoring bladder cancer recurrence and is followed by an active pipeline focused on developing best-in-class yet affordable blood tests for early detection of lung cancer.
We encourage you to express your interest in this opportunity by sending your responses directly to us. Please send your application or reactions to: Jobs@Nucleix.com. We look forward to hearing from you!
JOB SUMMARY:
The (CTA) Clinical Trial Assistant, will be working closely with the clinical team to ensure the efficient and effective conduct of clinical studies. Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation, supplies, samples and reports according to the standard operating procedures, and maintenance of tracking information.
Responsibilities:
• Provide general administrative support to the Clinical Department.
• Assist the Clinical team in completion of all required tasks to meet departmental and
project goals.
• Support the Clinical team with study start-up and ongoing conduct of studies.
• Assist project team with study specific documentation and guidelines.
• Set up, organize and maintain clinical study documentation (e.g. Investigator site file, eTMF,
CRFs, etc.) including preparation for internal/external audits, review and reconciliation.
• Process Data Collection Forms i.e. log in, tracking and quality control for the study.
• Coordinate ordering/distribution and tracking of trial materials (e.g. lab supplies, forms
etc.).
• Coordinate and track shipments of trial samples.
• Support project team with trial progress tracking by updating the relevant study systems.
• Assist in coordination and tracking of site payments and other study related
budget/invoices, as applicable (e.g. CRO, vendors and central lab).
• Participate and interact with clinical sites and vendors such as: CRO and Central labs.
• To be familiar with ICH GCP, appropriate regulations, relevant company’s SOP’s and internal
systems.
• To be familiar with the roles of the Clinical Research Associates (CRA) including site visits.
• Contact clinical sites to obtain study documents (e.g., enrollment logs, missing forms, etc.).
• Coordinate translations.
• Assist the project team with coordinating and preparing meetings and generate meeting
minutes.
• Assist in the generation of slide presentations, tracking spreadsheets etc.
• Support Clinical department activities with other tasks as may be needed, from time to
time.
Requirements:
• BA/BSc (or equivalent) in one of the life sciences or health care - required.
• GCP and/or CRA certificate – an advantage.
• Research or health care related work experience - preferred.
• Study coordination or research assistance experience or prior Clinical Research Organization (CRO) experience - preferred.
• Computer skills including working knowledge of Microsoft Word, Excel, PowerPoint and Outlook - required.
• Administrative support experience - an advantage.
• Excellent organizational skills, ability to manage multiple tasks and attention to detail.
• Excellent written and verbal communication skills - must be fluent in both English and Hebrew.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, sites and vendors.
• Willingness to travel for job related activities if required.