Regional CRA - CNS
One of our clients is currently seeking to fill multiple Regional Clinical Research Associate (CRA) roles across the US! The Senior CRA role will report to their manager as assigned and will ensure that clinical trials are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs), the principles of ICH/Good Clinical Practice and all applicable regulations governing the conduct of clinical trials. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually.
In this role you will be responsible for:
- Ensure clinical trial sites are audit ready via assisting to resolve monitoring and auditing findings.
- Responsible for all aspects of study monitoring process (including site selection visits, initiation visits, interim monitoring visits, close out visits) to ensure site’s compliance to the study protocol, subject safety and applicable regulatory requirements including on time reports, conf. and follow up letters.
- Serve as main point of contact for Investigative Sites to facilitate the proper conduct of the study by ensuring compliance with GCP/ICH guidelines, regulations, SOPs, ALCOA principles and training/ study/ safety monitoring plans. Activities include but not limited to source data verification and review of all required essential documents necessary for study initiation to close of study to ensure subject safety, reporting of quality data, Investigator oversight, drug accountability, ISF/ regulatory compliance, AE reporting and audit ready study files through duration of study.
- Ensure and mentor and in cases, where appropriate, manage jr staff in integrity of site collected data, accurate resolution of data queries, creation of clean data within timelines for database locks. Identifies site performance trends, with escalation and re-training as needed.
- Effectively communicate, facilitate exchange of ideas, and collaborate with Investigators, site staff, cross functional teams and other internal and external stakeholders. Oversight and review of training materials for site teams.
- Create back up plans as needed for successfully assisting sites reach agreed upon goals, serving as an escalation for jr. staff having issues getting goals met.
- Prepare and lead others in the preparation of study materials such as training slides and/ or other study documents
- Prepare, review, maintain, and mentor staff in accurate monitoring reports and sponsor/ Site correspondence within assigned timelines
- Collect, manage, file and archive study documentation and correspondence. Assist in the accuracy and completeness of the Trial Master Files (TMF)
- Ensure each site has the trial supplies needed to safely conduct the study. Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
- A bio-medical related scientific degree or relevant experience with a strong interest in clinical research.
- Minimum of Bachelor degree preferred.
- 3-4 yrs CRA, site management and monitoring experience on behalf of a sponsor/ CRO/relevant site or lab experience as it pertains to the role is required as well as knowledge of U.S. (or relevant country) regulations governing clinical trials.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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