2017 Research Summer Internship: Clinical Trial Assistant
Internship East Hanover (Morris County)
Job description
Job Description
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information.
Translational Medicine/Clinical Sciences & Innovation works to bridge the gap between the pre-clinical and clinical phases of drug development. Promising compounds are selectively chosen from the discovery phase and developed in man.
The Clinical Trial Leader manages all aspects clinical trials. He/she is assigned to a trial 2-6 months before commencement and is responsible for protocol development, study site selection, case report form development, drug supply, clinical database activities, and study site training in protocol procedures. During the conduct of the trial, the main responsibility of the Clinical Trial Leader is to oversee the study execution. After completion of the study, the Clinical Trial Leader is responsible for close-out activities, data management and study report writing.
The intern will serve as the Clinical Trial Assistant, and will be asked to perform a wide variety of tasks, which may include, but are not limited to:
• Compiling trial registrations for the clinicaltrials.gov public disclosure website
• Supporting Clinical Trial Leaders (CTL) in the set-up of an eTMF process for assigned studies
• Supporting CTLs in the maintenance of trial documentation
• Supporting set-up of eTMF Table of Content at study start and update as appropriate during study in agreement with CTL
• Supporting Contribute to the creation/harmonization of templates/guidance's, e.g. trial document delivery plan template, document tracking tools, training materials, TMF QC guidance's
• Assisting in maintaining tracking of trial master file locations (during study and upon archiving)
• Acting as back-up or provide support to other Trial Document Specialists globally depending on local requirements and resource availability, for selected studies
• Helping with generating study specific documents, e.g. study checklists, drug shipment documentation, Vendor Activity Worksheets, Clinical Study Report appendices
• Assisting in the review of study specific documents, e.g. study protocols, Case Report Forms, Informed Consent Forms etc (QC)
• Administrative tasks including e-mailing, printing, copying, faxing, filing and mailing
Novartis is an Equal Opportunity Employer.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Desired profile
Minimum requirements
- Actively enrolled college/university student, sophomore year student preferred
- Ideal candidate would be a self-starter with the ability to work independently and meet timelines
- Interpersonal skills with demonstrated ability to build collaborative relationships across multiple functions
- Intermediate knowledge of Microsoft Office (i.e. word, excel, etc)
- Team player with excellent customer focus
- Strong verbal and written communication skills
- Must be available to work a minimum of 12 week, full time