Clinical Research Regulatory Specialist

The Heart Hospital

Plano, TX

JOB SUMMARY

The Clinical Research Regulatory Specialist helps clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure. The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external and federal policies and regulations pertinent to research involving human subjects. This position also provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures and regulations.

ESSENTIAL FUNCTIONS OF THE ROLE

• Prepares, facilitates and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
• Ensures that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB. Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions.
• Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research. Obtains Sponsor approval of consent form prior to submission to the IRB.
• Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by partnering with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents. Ensures that regulatory binders are audited and maintained.
• Tracks workload and status of pending protocols and associated upholding documents in order to provide efficient customer service to the Research team.
• Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed. Oversees QA initiatives for the department to help research staff and managers during sponsor and FDA audits.
• Facilitates investigator-initiated research by ensuring all regulatory requirements are met, to include ensuring requirements for trial registration, results and reporting are completed in a timely manner consistent with federal regulations.

KEY SUCCESS FACTORS

• Proven written and oral communication skills.
• Proven leadership skills in project management, including project management tools and techniques.
• Exceptional computer skills, including Microsoft Office, Excel and PowerPoint.
• Ability to manage time reactive projects in order to meet deadlines.
• Excellent ability to establish and maintain effective working relationships.

BENEFITS

Our competitive benefits package includes the following.

• Immediate eligibility for health and welfare benefits
• 401(k) savings plan with dollar-for-dollar match up to 5%
• Tuition Reimbursement
• PTO accrual beginning Day 1

Note: Benefits may vary based upon position type and/or level

QUALIFICATIONS

• EDUCATION - Associate's or 2 years of work experience above the minimum qualification
• EXPERIENCE - 3 Years of Experience