Randstad Regulatory Analyst in Valencia, California
salary:$33.55 - $40.26 per hour
date posted:Friday, February 8, 2019
industry:Miscellaneous Manufacturing Industries
Contract position: Our client in Valencia is a leading medical device manufacturer, and they have an immediate opening for a Clinical Trial Coordinator. In this role the ideal candidate will act as a Trial Operations Clinical Research Associate, and work with clinical project teams and Clinical Research Associates to support the completion of clinical trial documentation processes, budgets, contracts and device management. You will also provide support to clinical functions and site customers through study and site start up, enrollment, follow up and closure phases of clinical trial activities.
Responsibilities for the Regulatory Analyst
Collect study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database.
Process core study documents (upload, assigning of attributes, filing, review and approval of subset of documents in eTMF).
Manage Study Master files and heavy documentation
Ensure successful study start-up (e.g. site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study
Requirements for the Regulatory Analyst
Bachelor's degree and 5+ years of related experience or an equivalent combination of education and experience
Experience in human clinical study experience required
Experience following SOP and WIs in a quality environment
Experience working with CTMS and eTMF systems, ICF (Informed Consent Form) review
Solid understanding and working knowledge of Clinical Study Regulatory requirements.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.