Randstad Regulatory in Spring, Texas
Tuesday, October 4, 2016
Randstad Life Sciences
Job Title: Regulatory Specialist
Project manages collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through CTMS. Evaluates accuracy and GCP compliance of received documentation, accepts or rejects the documents.
Maintains study trial master file in paper/electronic formats. Ensures file is continuously updated and prepared for audits. Broad based understanding of US Oncology Research processes and operational goals.
Manages process for study modifications: examines sponsor correspondence to identify changes and assess whether new information has been appropriately incorporated in companion materials. Alters patient informed consent as needed to ensure new information is captured. Reviews informed consents and ensures all required elements are captured to ensure compliance and patient protection. Translates protocol schema into lay terms to create study-specific patient informed consent document on behalf of physician investigators.
Facilitates IRB approval and renewal of clinical protocols, IDB, advertising materials, consent forms and other items required by the IRB, trial sponsor or FDA as required by federal research regulations.
Establishes process and timelines for clinical trial activation for regulatory readiness on behalf of each participating site as well as ongoing study maintenance phase. - Communicates with sponsors and CROs on study logistics, troubleshooting and resolving issues to maintain integrity of the clinical trial. Identifies, analyzes, researches complex regulatory and business process issues and makes appropriate recommendations.
Leads coordination of trans-departmental review of patient informed consent. Collaborates with representatives from multiple departments including project management, finance and IRB; research staff including the study investigator; and external clients including study sponsor and sponsor s authorized representatives to analyze patient informed consent document for accuracy, consistency and adherence to study protocol, budget and regulatory requirements.
Other duties as assigned
4-year degree in related field or equivalent experience required.
Possesses up to date knowledge of the profession and industry; accesses and uses other expert resources when appropriate
2 years in Clinical Research experience required, 1 year regulatory affairs required.
Proficiency with computer systems and Microsoft Office (Outlook, Word, Power Point, and Excel) required.
Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them.
8am - 5pm, M-F
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance