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Houston Methodist · 3 days ago

Regulatory Compliance Specialist - Cancer Clinical Trials

Houston, TX

Full-time

Onsite

Entry, Mid Level

2+ years exp

Houston Methodist is a leading academic institute, and they are seeking a Regulatory Compliance Specialist to coordinate and perform study-specific regulatory processes for cancer clinical trials. This role involves ensuring compliance with Good Clinical Practices and various regulatory requirements while maintaining documentation and communication with regulatory agencies.

Health CareMedical

Growth Opportunities

Responsibilities

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

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

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

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

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

Qualification

Regulatory complianceClinical researchClinical Practices (GCP)FDA regulationsRegulatory Affairs CertificationCertified Clinical Research CoordinatorCertified Clinical Research ProfessionalProcess improvementData analysisComputer skillsInterpersonal skillsPresentation skills

Required

Bachelor's degree or higher

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

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