The Clinical Trial Associate (CTA) is responsible for the management of the clinical trial documents, review of the site file document, assisting with the planning and development of the study documents, and oversight of clinical trial documents while ensuring the trial documents are managed in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable SOPs/Work Instructions.
Responsibilities
Study Planning and Conduct:
Set up eTMF system, as appropriate
Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations
Handle incoming and outgoing shipments, as needed
Assist with all aspects of initial study drug release including regulatory packet review and study-drug release
Assist in the preparation of study-specific training materials
Participate in the planning of investigator meetings
Assist in the development of case report forms and participate in the EDC and IVRS specification process, as appropriate
File clinical documents and maintain clinical research files (i.e., central files for studies)
Participate in support of regional Field Monitors
Interact with sites as needed to respond to issues
Monitor and track ALL monitoring visit reports (in SharePoint and eTMF)
Responsible for tracking of clinical trial progress including status update reports, as required
Participate in the review of clinical data at the case report form, data listing, and report table levels
Assist with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, IND Annual Updates, NDAs, and other documents, as required
Participate in clinical teams, including attending required meeting, and interact in a positive, professional manner.
Maintain training update to date including review and sign off all SOPs
Identify and escalate issues appropriately.
Set up clinical trials in ‘Clinicaltrial.gov’ and maintain until end-of-study
Support study team in IRB submission and updates
Manage study meeting calendar
Draft study meeting agendas and take study meeting minutes
Maintains completion of required corporate training on standards, policies, work instructions by due date
Performs other work-related duties as assigned
Qualifications
A bachelor's degree in biology, life sciences, health sciences, healthcare administration, psychology or business.
At least 1-2 years of experience working in clinical trials, medical research, or a CRO.
Familiarity with Good Clinical Practice (GCP) guidelines and Institutional Review Board (IRB) is essential.
Understanding of relevant regulatory agencies like the FDA is preferred.
Strong organizational skills and meticulous attention to details.
Excellent communication skills, both written and verbal.
What we look for in our people
Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development
Desire to work in a quickly changing and fast-paced growing business
Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done
Ability to overcome ambiguity and challenge the status quo
Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently
Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders
As an equal opportunity employer, Neurocentria is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Employment type
Full-time
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