Clinical Research Regulatory Specialist

Job Description

Job Description

Benefits:

• Competitive salary
• Health insurance
• Paid time off
• Tuition assistance
• Vision insurance

SMS Clinical Research is currently seeking candidates for a Clinical Research Regulatory Specialist for their office in Mesquite TX

JOB SUMMARY

• The Regulatory Specialist is responsible for ensuring clinical research studies comply with all applicable regulatory guidelines, including those set by the FDA and ethics committees, by managing regulatory submissions, coordinating with study teams, and maintaining accurate documentation throughout the clinical trial process, acting as a key liaison between researchers, sponsors, and regulatory agencies; their primary focus is to facilitate study start-up, conduct, and closure while adhering to all regulatory standards. 

ESSENTIAL JOB DUTIES:

• Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms.
• Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.
• Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for research project goals. 
• Manages and maintains electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. 
• Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.
• Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. 
• Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.
• Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.
• Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). 
• Maintains compliance with Good Clinical Practice (GCP) guidelines, ALCOA guidelines, patient confidentiality (HIPAA) and any other applicable laws.
• Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. 
• Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial startup and progress.
• Performs QC/QA on all visits as per SOP.
• Performs other related duties as assigned.

OTHER SKILLS/ABILITIES:
 

• Regulatory experience required; paper and electronic. 
• Willingness to work in a fast-paced environment where processes change and improve continually. 
• Able to function independently without constant supervision and adapt to change. 
• Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach. 
• Ability to effectively devote keen and acute attention to detail. 
• Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Internet Browsers
• Professional and highly motivated “self-starter” with the ability to exercise initiative. 
• Excellent task management and prioritization skills. 
• Strong verbal and interpersonal skills. 
• Excellent follow up skill.

EDUCATION AND EXPERIENCE:
· Minimum education is a Bachelor's degree, or an equivalent combination of experience, education and training.
· Knowledge of clinical research practices.

If you meet the above qualifications, please submit your resume for immediate consideration.