Job Description

At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under the direct supervision from the management, this position addresses problem solving issues of moderate to complex scope and assists with internal departmental monitoring and research education as identified by the Manager or Director.

Additional Information: Ideal applicants will have prior work experience with FDA Form 1571 (Investigational New Drug Application (IND) submissions, e xpanded access protocol submissions under an existing Sponsor IND, s ubmitting a new expanded access IND submission for HM Neal Cancer CTR IIT's, and  FDA Form 3926 submissions. Applicants with this experience will receive priority.

Requirements:

PEOPLE ESSENTIAL FUNCTIONS

• Builds and maintains effective relationships with key study personnel.

• Acts as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved, and that supplementary information is provided in a timely fashion as requested.

• Assists in training study personnel and others on regulatory and safety reporting processes, and procedures under the direct supervision of the Manager or Director (serves as a resource for regulatory information and guidance).

• Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.

SERVICE ESSENTIAL FUNCTIONS

• Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA, GCP, NIH and applicable regulations.

• Assists in the preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors. Submits adverse event reports, safety reports, and notifies IRB of study closures.

• Maintains the required regulatory files for all clinical trials to ensure regulatory compliance. Meets with study monitors. Maintains archived documents on and off site.

• May assist in the preparation of periodic reports for FDA.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Provide routine updates and reporting to the Manager or Director to ensure timely communication regarding status of regulatory and/or important safety related issues.

• Perform high quality clinical review of regulatory forms and associated documentation (during internal monitoring or review of trials).

• Prepare and manage documents required to initiate investigational drugs trials.

• Maintain a professional and credible image with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers.

FINANCE ESSENTIAL FUNCTIONS

• Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

Qualifications:

EDUCATION

• Bachelor's degree or higher

WORK EXPERIENCE

• Two years of clinical research, regulatory compliance, or equivalent applicable work experience within an academic research environment or FDA regulated industry

• Experience in medical devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting highly preferred

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

LICENSES AND CERTIFICATIONS - PREFERRED

• RAC - Regulatory Affairs Certifications (RAPS) OR
• CCRC - Certified Clinical Research Coordinator (ACRP) OR
• CCRP - Certified Clinical Research Professional (SOCRA)

KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security

• Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

• Demonstrates knowledge and application of process improvement tools and techniques (statistical process control tools and team tools)

• Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement

• Skill in developing and maintaining interpersonal relationships with a wide variety of healthcare professionals and hospital leadership

• Ability to define problems, collect data, establish facts, and draw valid conclusions and evidence performance improvement via measurable results

• Ability to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processes

• Computer skills: Excel, Word, PowerPoint

• Ability to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievement

• Ability to work independently and interdependently

• Presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform No
• Scrubs No
• Business professional Yes
• Other (department approved) No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

• On Call* No

TRAVEL**
**Travel specifications may vary by department**

• May require travel within the Houston Metropolitan area No
• May require travel outside Houston Metropolitan area No

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