Regulatory Specialist for Oncology Research in Conroe, TX

Conroe, Texas
Job Type
US$ 20.00 - US$ 24.00 per hour, $20 - 24 per hour + none
Ref. Number
Wilson, Jasmine, Spherion
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Job Description

- Demonstrates fundamental understanding of US Oncology Research processes, business and operational goals. Collaborates with team initiatives and serves as support for senior members of the team to deliver action items and products to our sites, IRB and sponsor/CRO clients. Understands the importance of building relationships with key stakeholder and business partners. Ensures accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Analyzes regulatory requirements, identify potential conflicts, and have thorough knowledge and ability to apply federal regulations and USOR policies. Maintains awareness, excellent comprehension and appropriate application of relevant regulations. - Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation. Ensures all assigned trial regulatory obligations are managed compliantly with FDA regulations. Maintains compliance and integrity of study trial master file in paper/electronic formats. Ensures file is continuously updated and prepared for audits. - Manages, completes, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, deviations, etc. Reviews study procedures to determine whether supporting documents (i.e. patient diaries and surveys) are required. - Establishes process and timelines for clinical trial activation for regulatory readiness on behalf of each participating site as well as ongoing study maintenance phase. - Leads coordination of trans-departmental review of patient informed consent. Notifies IRB of trial changes, enrollment status and protocol deviations.

Working hours: M-F, 8-5

- 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
- 3 years in Clinical Research experience required, 2 years regulatory affairs required, 2 years oncology experience is preferred.
- Proficiency with computer systems and Microsoft Office (Outlook, Word, Power Point, and Excel) required.
- Shows Work Commitment: Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them.
- Discretionary decision-making and independent judgment skills. Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines. Must be precise, thorough, reliable, and perform daily activities with minimal supervision.
- Knowledge of clinical research process and regulations. Demonstrated analytical skills; ability to create ad hoc reports, tracking tools, and professional documents; and the ability to interpret and apply complex government regulations.

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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