Regulatory Specialist

Regulatory Specialist SCLA Management Houston, TX Job Details Full-time $50,000 - $55,000 a year 5 hours ago Qualifications Optimizing workflow processes Responsible conduct of research Teamwork Bachelor's degree Process management Full Job Description Job Summary The Regulatory Specialist will be responsible for revising, submitting and maintaining all relevant regulatory documents for all trials that SCLA Management as contracted to participate in. The specialist will be the main point of contact for all coordinators in regards to any regulatory and IRB activities related to clinical trials.

Primary Responsibilities:

Independently develops and submits Study Institutional Review Board (IRB) documents such as consent forms and protocols for initial submissions, protocol amendments, and continuing reviews. Independently maintains appropriate study documentation including regulatory binders and enrollment logs in collaboration with the clinical research coordinator. Responsible for preparing, maintaining and updating electronic regulatory binders for review by internal or external monitoring/auditing groups. Submits Protocol Deviations in a timely manner and in collaboration with the clinical research coordinator according to the Central IRB and sponsor-specific reporting requirements. Assesses current departmental processes and SOPs; provides suggestions for improvement. Assists research team members in assessing and optimizing departmental workflows. Maintains understanding of the professional guidelines and code of ethics related to clinical research conduct. Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies. Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved. Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues. Assist in maintaining current regulatory documents during the entire clinical trial process. Other duties and responsibilities as assigned

Experience:

• Clinical Research experience in a Regulatory or relevant position • Bachelor's Degree preferred but not required

Pay:

$50,000.00 - $55,000.00 per year

Work Location:

In person