Clinical Research Associate. Job in Aliso Viejo FOX8 Jobs
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Description:
study compliance guide site support closure of data queries follow-up on safety issues and safety reports identify, document, and assist in the resolution of issues relating to subject recruitment, study data quality, and study conduct manage clinical study sites analyze and validate data to maintain regulatory compliance study start up - collection and tracking of documentation creation and preparation of study specific documentation and processes periodic assessments of documents submitted to the eTMF manage an assessment tracking tool timely submission of documents to applicable regulatory authorities awareness of study events and associated documentation requirements site-specific recruitment and retention plan regularly reviewing site recruitment timely implementation of contingency plans point of contact for study-related questions and issues from study sites status of site activity
Skills:
Data analysis, data management, study monitoring, clinical operations, Clinical research, microsoft office, edc, etmf, study start up, clinical trial
Top Skills Details:
Data analysis,data management,study monitoring,clinical operations
Additional Skills & Qualifications:
ICH GCP Guidelines local regulatory requirements Microsoft Office EDC systems eTMF clinical research associate
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.