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Sr. Clinical Research Associate (Sr. LTM)-2972130717
Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for an Sr. Clinical Research Associate (Sr. LTM), located in Raritan, NJ. (Other locations possible: Titusville, NJ; Springhouse, PA; Los Angeles, CA)
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.
Responsibilities include trial operations/oversight at the country level by ensuring study related activities are in compliance with all GCO SOPs, policies and regulatory requirements from start-up through data-base lock. Supervise site/investigator selection process and monitor site performance for his/her country. Partner with the CTA/IDA, SM, Contracts and Grants group and GTM to ensure overall site management while performing trial related activities for assigned protocols. Represent functional area in divisional/company-wide process initiatives.
The qualified individual will be responsible for, but not limited to the following activities:
Supports country/site feasibility assessment in conjunction with Lead LTM, CTA/IDA and GTM.
Collaborates with the RTAE/CPL, GTM and Protocol Owner to select final site list.
Holds weekly RSM meetings and provides SM training when needed (i.e., for implementation of study amendments/changes in study processes).
Contributes to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates for a single country trial.
Creates various trial related documents including Country Feasibility Report, Trial Master Spreadsheet and country specific ICF template.
Submits requests for vendor services and supports vendor selection.
Collaborates and reviews study budget with Global Operations Services and updates budget forecast in CTMS.
Reviews eCRFs/Completion guidelines and participates in EDC UAT in conjunction with Lead SM/SM EDC Specialist; collaborates with CDM during analyses to ensure report accuracy and to resolve site specific data issues.
Partners with vendors to ensure study supplies are provided to sites and participates in IVRS UAT.
Contributes to recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets.
Coordinates/presents at Investigator Meetings as needed.
Attends regularly scheduled team meetings and trainings.
Tracks, reviews and signs-off on SM Trip Reports; identifies trends across the project and escalates to the GTM as needed.
Processes, reviews and approves site and local vendor invoices.
Supports regulatory requests and ensures appendix 1.4.1 is accurate and complete.
Works with SM to ensure CAPP is completed for QA site audits.
Ensures, in collaboration with SM, the timely and accurate data collection, documentation and communication of study progress and issues.
Maintains/updates the eTMF LAF, Trial Master Source and SharePoint.
Responsible for ensuring all activities are executed according to internal SOPs/WIs/IFUs and policies.
Function as Trial Manager for single country trials as needed.
Mentors new hires with supervision.
Participates in special initiatives as needed.
A minimum of a Bachelor's degree is required. Degree in a health or science major is preferred. Minimum of 4 years pharmaceutical experience is required. Specific Oncology therapeutic area experience is required. Previous clinical operations experience preferred. Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations required. Solid communication and computer skills required. Minimal travel may be required.
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Primary Location:North America-United States-Pennsylvania-Spring House
Other Locations:North America-United States-California-Los Angeles, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Administration
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Deadline: Saturday, 3 August 2013