In-House Clinical Research Associate (iCRA)
San Jose, CA, USA | Becton Dickinson & Company
Functions:Operations / Production
Job Description:53 people have viewed this job
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 help ensuring the overall quality of clinical trials by tracking study- and study site-related data as per the instructions of the project manager (PM). The iCRA works closely with the PM and helps with the monitoring of site adherence to the protocol, adherence to GCP, other applicable regulations and related study documents. The CRA can function as the primary contact with remote- and field-based CRAs, clinical investigators and BD study team members. iCRA is responsible for the tracking of regulatory documents, helps overseeing site screening and enrollment efforts, supports safety reviews and reporting, and acts as the primary point of contact for the ClinOps systems. The iCRA will be assigned to support multiple clinical trial sites and studies in parallel. The iCRA may contribute to the development and improvement of company procedures, processes, and templates in support of BD’s efforts towards continuous quality improvement.
Essential Job Functions:
• Supports sponsoring divisions and 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
• Serves as a Study eTMF Owner, Provides Level 1 support, completes QC review
• Completes CTMS with study- and site-specific data, supports the set-up of the monitoring visit report process, and helps with eventual troubleshooting
• Assists in the preparation of study binders, manuals, or other site-specific tools
• Provides monitoring visit support as needed, e.g. helps with the visit preparation and supports site qualification, site training, routine monitoring and close out visits, as well as monitoring visit reporting, if needed
• Upon request, helps with investigational device supplies and device accountability to help the CRA ensuring the devices are available, stored appropriately, and are accurately inventoried and documented
• Verifies appropriate reporting and documentation of adverse events and protocol deviations per internal and protocol requirements
Ensures TMF and site regulatory binder are current and aligned, performs gap analyses as needed
- Bachelor's Degree in Life Sciences (Chemistry, Biology, etc) or related
- 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
- Two or more years as an on-site or in-house CRA.
- Understanding of GCPs, Site Management, Study Budgets, Working with Clinical Investigators and StudyCoordinators.
- Medical device experience preferred
- Proficient in MS Office Suite of products
- Demonstrate problem solving and conflict management skills
- Excellent interpersonal and communication skills
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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