Research Compliance Specialist, Ocr Firenze

Research Compliance Specialist, Ocr
Firenze
Toscana, Firenze

Please see Special Instructions for more details.

Employer will not sponsor for employment Visa status I.

JOB OVERVIEW Job Description Summary: Founded in 1824, the GW School of Medicine and Health Sciences ( SMHS ) is the 11th oldest medical school in the country and the first in the nation's capital.

Since its establishment, the school has been at the forefront of medical education, and has grown to include highly-ranked programs in the health and biomedical sciences.

With dozens of top-tier residency programs, SMHS is a competitive and esteemed destination for medical school graduates across the country.

Find out more here: The Research Compliance Specialist, OCR position will facilitate all regulatory and compliance aspects of clinical research, serving as the GW School of Medicine and Health Sciences, Office of Clinical Research leader for regulatory guidance, with responsibility for reinforcing, promoting, and sustaining the highest quality of clinical research. Reporting to the Director of Clinical Research Administration and Operations, this position will serve as a regulatory affairs and compliance resource providing support in various Quality Assurance Program functions.

This senior position serves as an expert resource for complex research compliance activities, both internally and externally towards various stakeholders, including the GW Medical Faculty Associates ( MFA ).

The incumbent will ensure the implementation of research quality assurance, risk assessment, and reduction strategies.

Responsibilities may include developing and revising internal inspection plans, internal monitoring visit tools, and standard operating procedures; organizing and delivering individual and group education programs; and other activities as assigned.

The role requires employment experience with Phase I through Phase IV trials as it pertains to clinical research operations.

This position will also assume oversight of all clinical research systems such as our eRegulatory binder, eConsent, RedCap, and systems oversight for CITI and clinicaltrials. gov. Duties: Interface with the GW IRB , Western IRB , University offices supporting research, research institutes, and University, MFA and Hospital Privacy officers on regulatory matters, and ensure that MFA processes are well-integrated with the GWU IRB's processes.

Acts as interface with MFA compliance department and liaisons for problem analysis, status, information technology or legal reviews about research compliance issues Proactively detect, eliminate, and prevent regulatory compliance issues, minimize institutional risk, and improve research subject safety, and provide routine updates and reporting to the Director to ensure timely communication regarding the status of regulatory and/or important compliance or safety-related issues Serves as MFA institutional point of contact for FDA audits, regulatory inspections, and addressing issues of non-compliance with the MFA Director of Research, MFA compliance office, MFA Privacy Officer, University officials, other senior management, as needed, and is the senior point of contact for faculty and coordinators who have questions/problems concerning compliance, regulatory matters Develop system-wide best practices that will serve as standard management of regulatory functions required for the conduct of all clinical research and for ensuring regulatory compliance for all clinical research conducted throughout GW In partnership with the IRB and the compliance office, the Research Regulatory Compliance Sr Manager, serves as the system's subject matter expert for regulatory requirements involved in the conduct of industry-sponsored, federally funded or foundation clinical trials and for regulatory strategic planning to ensure compliance with clinical research conducted throughout GW Supports Executive Director Clinical Research in creating a system-wide strategy for the interconnectedness of clinical research regulatory functions within the GW Enterprise and is intricately involved in maximizing efficiencies, remaining cutting-edge with best practices, and educating relevant stakeholders Oversees the collection, completion, and maintenance of mandatory research documents associated with applicable research studies, including template documents needed for study start-up through closure of a research study where applicable Serve as primary resource for issues related to external audits and assistance for PIs and study teams during external federal audits and assistance with responses to federal agencies (Form FDA 483, EMA audit reports, NIH audit reports, etc. )

and serve as expert liaison in specialized compliance or regulatory area between the investigators, coordinators and regulatory agencies, provide regulatory support, guidance, and information to principal investigators and research staff.

Works with all parties to ensure that research projects comply with with policies and procedures of the sponsors, IRBs, Federal, State, and FDA regulations, and institution Facilitates necessary access to clinical trial management system ( CTMS ) and electronic health records ( EHR ) for monitors and serves as point of contact to assist in remote monitor visit Implements and maximizes utilization of an eRegulatory system (Florence) throughout the enterprise Manages eConsent platform and other related technologies.

Ensures oversight and compliance with clinicaltrials. gov records Develops educational training programs for research teams regarding regulations, regulatory requirement Conducts audits within established program timeframes, following institutional standard operating procedures ( SOP ), Good Clinical Practices ( GCP ), Office of Human Research Protections ( OHRP ) and Food and Drug Administration ( FDA ) regulations and guidance documents Authors accurate, detailed internal inspection reports that document compliance findings and provide regulatory citations.

Follows up with auditees to ensure that audit responses and corrective and preventative action plans ( CAPA ) are provided promptly, allowing for audit closure Provides current and accurate compliance information and resources to the research community.

Provides information and services to help research with FDA and sponsor inspection readiness Performs other related duties as assigned.

The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications: Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 7 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 5 years of relevant professional experience.

Degree must be conferred by the start date of the position.

Degree requirements may be substituted with an equivalent combination of education, training and experience.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Preferred Qualifications: Preferably 6+ years experience in clinical research administration and appointment within the past 5 years serving on an Institutional Review Board or commensurate experience or past job working closely with an IRB Excellent verbal and written communication skills Strong interpersonal skills allowing the individual to work effectively with individuals within and outside of the MFA Ability to input data into a computer and analyze data per request Exceptional interpersonal skills and flexibility when working with a diverse group of people Ability to follow and understand instructions College/School/Department: School of Medicine and Health Sciences (SMHS) Family Family Research Administration Sub-Family Sub-Family Research Compliance Stream Level Level Level 4 Full-Time/Part-Time: Full-Time/Part-Time: Full-Time Hours Per Week: 40 Work Schedule: Work Schedule: Monday through Friday, 8:30 am - 5:00 pm Will this job require the employee to work on site?

Will this job require the employee to work on site?

Yes Employee Onsite Status Employee Onsite Status Hybrid Telework: Telework: Yes Required Background Check: Required Background Check: Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search Special Instructions to Applicants: Employer will not sponsor for employment Visa status Internal Applicants Only?

Internal Applicants Only?

No Posting Number: Posting Number: S013097 Job Open Date: Job Open Date: 06/12/2024 Job Close Date: If temporary, grant funded or limited term appointment, position funded until: Background Screening Successful Completion of a Background Screening will be required as a condition of hire.

EEO Statement: The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.

Posting Specific Questions Required fields are indicated with an asterisk (*).

* Are you currently employed with The George Washington University? No Yes * For current GW employees, have you completed your Introductory Employment Period (IEP)?

(As a reminder,  employees in their IEP are not eligible to apply for other internal university staff and research positions until the IEP is complete.

)Yes, IEP complete No, still in IEP N/a - not a current GW employee * What is your salary range expectation?

(Open Ended Question) Documents needed to Apply Required Documents Resume Cover Letter Optional Documents Human ResourceManagement & Development 2013 H Street, NW, 3rd FloorWashington, DC 20006 #J-18808-Ljbffr