Job Duration: 6+ months
Location: East Hanover, NJ
- Assist in the operational and logistical aspects of clinical trials according to GCP (Good Clinical Practice) and relevant CLIENT procedures and assist in delegated tasks to support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study.
- Provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth running of clinical trials in compliance with CLIENT processes.
- Collaborate with the CTL in taking action to address issues as they arise.
- Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations.
- Identify issues and take appropriate corrective action as necessary.
- Interactions with Investigator sites e.g. to collect relevant documentation, provision of study materials / documents.
- Liaise with contract organizations, vendors and other suppliers of project support services to ensure study deliverables are met e.g. contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups.
- Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings e.g. internal CTL meetings or external investigator meetings. May attend and present at these meetings as appropriate.
- Help ensure accuracy of clinical trial management databases and resource/budget tracking tools, providing information, maintaining meeting minutes and following up on questions as necessary.
- Help check for discrepancies and take actions to correct as necessary.
- Identify areas for process or technology improvements with regard to tasks undertaken within the role.
- Assist in the ordering of clinical trial supplies.
- Assist in the compilation of the clinical study report and its appendices.
- Responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines.
- Assist the CTL in organizing Investigator/Site Initiation Meetings and/or First Dose/Monitoring Visits. Attend at least 1 of these meetings and assist the CTL in conducting.
- Maintenance of knowledge and training of ICH-GCP, current regulations and procedures.
- Fluent English
- Previous experience in clinical trials (e.g. clinical trial design, execution and operations) is preferred but not required
- Good organizational and interpersonal skills.
- Ability to work in a team as well as independently if required and to manage multiple priorities with support.
- Computer literate.
- A bachelor’s degree or equivalent qualification or work experience in life sciences or nursing.
Kindly call Himanshu (201-489-7705 x 106) to discuss this opportunity in details.
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