Actalent Hiring for Clinical Research Associate-Medical Device Job at Aliso Viejo, CA Full Time

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

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.