Clinical Trial Assistant Job

Company Name:
Janssen Research & Development, LLC. (60
Raritan, NJ, US
Clinical Trial Assistant
Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Clinical Trial Assistant to be based in Raritan or Titusville, NJ or Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Early Development & Clinical Pharmacology (ED&CP) Clinical Trial Assistant (CTA) is responsible for supporting the ED&CP Trial Manager (TM) and Site Manager (SM). Scope of work includes the management of all documents and logistical and administrative tasks related to trial start-up, execution and close out of clinical trials. The CTA performs the technical regulatory document review, including Informed Consent Forms. The CTA ensures trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements. Focus will primarily be on single country ED&CP trials, but CTA may also support small multi-country studies or local activities for larger multi-country studies. May contribute to process improvement.
Partners with the TM and SM to ensure overall study and site management and adherence to internal SOPs, policies and country regulatory requirements.
Supports the study team in performing study feasibility and site assessments.
Assists TM in management of study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary
Maintains trial, country, and site level protocol information in Trial Management Systems (e.g. CTMS, TMS, etc.).
In liaison with the TM ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.
Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
Supports the TM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
Supports the TM and SM collecting and maintaining all documents throughout the trial and post trial documents in both e-TMF and paper files and complete final reconciliation at the end of the trial.
If applicable, supports study specific SharePoint sites to ensure availability of trial documents to the study team
If applicable, supports the TM in the organization and management of meetings (i.e. takes minutes, follow up on action completion)
If applicable, supports TM in organization of training for SM(s) and/or small investigator meetings
Distributes, collects, reviews, and tracks regulatory documents, agreements and training documentation.
Collects and tracks Financial Disclosure information at appropriate time points.
May contribute to process improvement
Complies with relevant training requirements.
Supports TM with providing study information to vendors (e.g. site contact list ...)
Helps to ensure inspection and audit readiness
Negotiates site requested changes to the Confidential Disclosure Agreement; checks investigators and
IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts. Alerts TM of any deviation
Prepares Trial Center File and prepares or co-ordinates the development of any other document and review them for completeness and accuracy.
Assists the TM in conducting small investigator meetings or in making arrangements for the investigators participating in an international meeting (if applicable).
Supports the TM in drug distribution process.
Provides administrative and logistical support to the TM and SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate.
Supports the TM in compiling the List of Investigators for CSR (Appendix ) is accurate and complete.
Maintains and updates Intralinks contact information to ensure appropriate SUA distribution and if applicable disseminates SUA packet.
Maintains and transmits ERIS Transmittal Summary of 1572 and PI CV to Regulatory Affairs for NDA submission.
Archives off-site paper Trial Master File (TMF).
Supports the TM in compiling accurate/complete regulatory documents for submission to Health Authority/ EC-IRB at country level.
Upon request from TM, reviews Informed Consent Form (ICF) for completeness to facilitate the approval of changes to mandated J&J language in collaboration with legal department
A minimum of an Associate's degree is required. Bachelor's degree preferred. A minimum of 2 years relevant clinical trial experience is required. Must be proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint) is required. Strong interpersonal and negotiating skills are required. Must have excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner. Specific Early Development & Clinical Pharmacology (ED&CP) experience is an asset.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:
North America-United States-New Jersey-Raritan
Other Locations:
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Job Function:
Clinical Trial Coordination
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Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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