Regulatory Compliance Specialist - Cancer Clinical Trials

Houston Methodist•Houston, TX

About The Position

FLSA STATUS Exempt QUALIFICATIONS EDUCATION Bachelor's degree or higher 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 Preferred RAC - Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA) 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 ESSENTIAL FUNCTIONS 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. 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

Requirements

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
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

Nice To Haves

Experience in medical devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting
RAC - Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA)

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.