At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external 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 for Department of Medicine will also work with industry sponsors’ or grant funder’s regulatory personnel for study regulatory start up and study regulatory maintenance throughout the study. This position communicates closely with the study teams including research coordinators, clinical trial managers, and principal investigators, sponsor partners, IRB staff, and regulatory office staff. Attention to detail, ability to navigate multiple projects and good time management are important in the success of this position. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.
PEOPLE ESSENTIAL FUNCTIONS
SERVICE ESSENTIAL FUNCTIONS
QUALITY/SAFETY ESSENTIAL FUNCTIONS
FINANCE ESSENTIAL FUNCTIONS
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
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.
EDUCATION
WORK EXPERIENCE
LICENSES AND CERTIFICATIONS - REQUIRED
KNOWLEDGE, SKILLS, AND ABILITIES
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
TRAVEL**
**Travel specifications may vary by department**
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.
Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.
Equal Employment Opportunity
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.
...force in the market at large. Job Duties and Responsibilities Boost Mobile is seeking a creative and results-driven Digital Content Manager with 2-3 years of experience to join our marketing team. The ideal candidate will be responsible for developing, implementing...
...experience needed) Our award winning Sales department is looking for Sales Associates... ...and using Microsoft Office, accounting software, and proprietary sales programs A personal... ...Car Sales, Teacher, Bartender, Server, Entry-level, Experienced, Experienced Sales, Cold...
...GENERAL SUMMARY: The Outpatient Clinical Documentation Specialist (CDS), in conjunction with physicians, coders, and clinical staff, will utilize documentation and coding expertise to facilitate the quality and completeness of medical record documentation of outpatient...
...Job Description Job Description Overview Now Hiring! Digital Content Manager Organization: Junior Achievement of South Florida Reports to: Senior Marketing Manager Schedule: Full Time, Exempt Location: Coconut Creek, FL 33066 (On-Site) Hours:...
...Job Description Job Description Parts Runner & Escort Driver ALL Crane Service, LLC Columbus, OH (43224) Position Summary ALL Crane Service, LLC is seeking a Parts Runner and Escort Driver. This is a non-exempt, full-time position with comprehensive Benefits...