In-House Clinical Research Associate (iCRA)

Becton Dickinson & Company - Franklin Lakes, NJ3.9

Full-time
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Job Description Summary
Job Description
The In-House Clinical Research Associate (iCRA) supports the day to day operations associated with the execution of clinical trials. The primary objective and purpose of this position is to provide support to clinical
project teams, with remote-review of site documentation and study data to ensure the overall quality of clinical trials.

The iCRA is the primary contact with remote- and field-based CRAs, and may serve as a secondary point of contact with clinical investigators and BD study team members, as assigned. The iCRA is responsible regulatory document collection, tracking screening and enrollment, supporting safety reviews and reporting. The iCRA will be assigned to support multiple clinical trial sites and studies. The iCRA is expected to contribute to the development and improvement of company procedures, processes, and templates in support of Global Clinical Development efforts towards continuous quality improvement.

Duties:
Supports global business units with TMF ownership and accountability
Builds new eTMF study, country and site binders; manages permission groups with direction from eTMF Business and Technical Owners
lServes as a Study eTMF Owner, Provides Level 1 support, completes QC review
Serves as a CTMS Power User, providing Level 1 support and maintenance in areas of
troubleshooting, contact, account, document and site management, monitoring visit report process and troubleshooting
Assist in the preparation of study binders, manuals, or other site specific tools
Provide monitoring visit support as a co-monitor as needed, and supports: site qualification, site training, routine monitoring and close out visits, monitoring visit reporting
Account for investigational devices ensuring the devices are available, stored appropriately, and accurately inventoried and documented
Verify appropriate reporting and documentation of adverse events and protocol deviations per internal and protocol requirements
Ensure TMF and site regulatory binder are current and aligned

Requirments:
BS / BA in a related scientific area, or demonstrable experience of prior performance in similar role
Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment
Minimum of 1 – 3 years of clinical research experience
Medical device, pharma or biotech experience
Mastery of MS Office Suite of products
Demonstrable problem solving skills, and developing conflict management skills
Excellent interpersonal and communication skills
Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
USA NC - Research Triangle Park
Work Shift
1st Shift 830am-5pm (United States of America)