Ensure clinical study data are accurate via source verification, query initiation and resolution
Ensure sites are following the clinical study protocol, GCP, and all applicable regulations
Conduct study site selection, qualification, training, start up, and close out
Support IRB submissions
Act as a primary contact between the site and the study sponsor
Ensure proper inventory, storage, shipment, and tracking of study materials
Ensure proper handling, storage, tracking, and shipment of clinical specimens
Assist with data entry as necessary
Maintain Trial Master Files for all assigned clinical studies I
Skills:
Clinical trial, ivd, in vitro diagnostics, clinical research, medical device
Additional Skills & Qualifications:
A BS/BA is required (biology, chemistry, or related scientific or healthcare field preferred)
A minimum of 2 years\' direct experience in clinical study monitoring is required
Experience in IVD studies is preferred, with a proven track record of progressive clinical study responsibility
Knowledge of medical terminology and good clinical practice required
Detail-oriented with a high level of organizational skills; good written and verbal communication skills; excellent interpersonal skills
Advanced computer skills (Word, Excel, Outlook, Access) or equivalent require
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.