Coordinator, Regulatory Resume Sample
Richie Reynolds
941 Franecki Ranch,
Los Angeles,
CA
+1 (555) 168 6123
Work Experience
Lead Coordinator Regulatory Affairs
05/2016
-
PRESENT
Chicago, IL
- Proficiencyt with MS Office, Windows XP and 7, Access
- Participates in the following: Performance Improvement Committee, Regulatory Compliance Committee, Environment of Care Committee, Home Care Council, Infection Control Committee, Reusable Medical Equipment Committee, Patient Safety Committee, CARF Committee, Imaging Committee, and others as necessary
- Leads the facility's tracer process, needs assessment and strategic planning processes, assuring the necessary interdisciplinary input to plan improvement/resolution across the ECHCS continuum of care
- Works collaboratively across service lines to ensure that facility programs and materials adhere to VHA program requirements and accreditation standards
- Abides by the VA's ethical standards of conduct and assures compliance with the ethical standards of VHA, the facility, and the profession
- Preserves the rights of others and promotes mutual respect among colleagues
- Serves as the primary resource/key contact for external accreditation reviews, including follow-up and tracking of actions to closure
Coordinator, Regulatory Compliance
06/2012
-
04/2016
Philadelphia, PA
- Plans and coordinates assessments and evaluation of organizational regulatory compliance readiness and implements strategies to promote ongoing survey readiness
- Organizes and conducts periodic assessments and mock surveys and tracers
- Ensures facility documents are regulatory compliance ready
- Develops educational training programs, materials and tools to promote staff understanding, compliance and continual regulatory compliance readiness
- Facilitates follow-up action plans and evidence of standards compliance with staff to ensure sustainability of improved performance
- Serves on ECHCS-wide committees/teams and participates in the design, measurement, assessment and improvement of important processes throughout the ECHCS
- Demonstrates competency in a variety of computer programs and has the ability to design tracking systems
- Setting up Quality Assurance (QA) panels to review rules where Credit Suisse (CS) is not fully compliant or where there are questions over rule interpretation and level of compliance. Taking minutes of QA panels, tracking actions, and checking that any revised responses address QA panel’s actions
Technical Coordinator, Regulatory Reporting
06/2009
-
01/2012
Houston, TX
- Proven financial sector experience, preferably in a risk management, internal audit, operational risk, legal and compliance role in an investment or large commercial bank, accountancy/consultancy firm or regulator
- Independently create and maintain deliverables related to the Board of Trustees, including various reports and annual calendar/agenda items
- Attend Trust Board meetings to facilitate presentation of Board materials
- Create complex presentations and reports using Windows-based software and PowerPoint
- Act as subject matter expert on the applications that support electronic Board materials, including coordination with the vendor
- Responsible for coordinating the enterprise-wide regulatory activities associated with the Bank’s regulators
- Responsible for coordinating the Bank’s responses to examination conclusions
Education
Herzing University Madison
2003 - 2008
Bachelor's Degree in Healthcare
Professional Skills
- Strong experience creating and maintaining reports, specifically with MS Word and Excel
- Intermediate computer skills: word processing, spreadsheet, database software and internet use
- Demonstrated ability to work in a fast paced, dynamic team environment with changing priorities
- Demonstrated experience working with IRBs (UA & central)
- Working experience with Microsoft Office products
- Skilled in using SharePoint
- Strong organizational and multi-tasking skil
How to write Coordinator, Regulatory Resume
Coordinator, Regulatory role is responsible for credit, software, finance, training, database, security, reporting, design, research, travel.
To write great resume for coordinator, regulatory job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Coordinator, Regulatory Resume
The section contact information is important in your coordinator, regulatory resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Coordinator, Regulatory Resume
The section work experience is an essential part of your coordinator, regulatory resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous coordinator, regulatory responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular coordinator, regulatory position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Coordinator, Regulatory resume experience can include:
- Valid certificate of CITI training for human subject’s research, or equivalent
- Valid state driver’s license as required by local authorities
- Supporting the Team’s technology
- Checking supply to sanctioned/embargoed countries have the correct licences
- Maintaining ERP systems with any changes to ITR policies and procedures
- Understanding/lnowledge of drug regulations
Education on a Coordinator, Regulatory Resume
Make sure to make education a priority on your coordinator, regulatory resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your coordinator, regulatory experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Coordinator, Regulatory Resume
When listing skills on your coordinator, regulatory resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical coordinator, regulatory skills:
- Experience with reading medical records
- Demonstrates flexibility, teamwork and systems thinking
- Effective working relationships with regulators and management
- Work experience in law or regulatory affairs
- Possess a valid California driver’s license
- Strong knowledge of Microsoft Outlook, Word, Excel, and PowerPoint and Adobe
List of Typical Experience For a Coordinator, Regulatory Resume
1
Experience For Coordinator, Regulatory Compliance Resume
- Identifies, reports and assists PI in the resolution of compliance issues/concerns
- Reports into the Institute and Research Compliance database per requirements
- Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics and drive improvement
- Provides education as needed. Maintains records, files and data for research regulatory and quality assurance efforts
- Assists with the preparation of documents to include protocols, investigator brochures, consent forms, and submissions to the FDA
2
Experience For Coordinator Regulatory White Oils & Food Resume
- Communicates with clinical, administrative and management personnel to gather or convey information
- Edits and prepares material for final review
- Works in conjunction with other administrative staff to accomplish program requirements
- Coordinate the production, filing, distribution and posting of regulatory documents, including testimony, workpapers supporting testimony, and responses to data requests
- Ensure that final documents are accurate and complete and that confidential information is properly identified and protected
- Ensure that all final case documents are posted in Regulatory Affairs’ records retention system
- Manage CPUC or FERC staff and intervener requests to access case documents via the internet or other means available
- Manage team SharePoint sites to give team members ready access to case documents and to eliminate version control issues
- During the hearing or settlement phase, assist with witness training, gathers documents required for hearings or technical conferences and manage logistics to ensure witnesses and case documents are available in the hearing room when needed; attend hearings and develop/maintain the case’s exhibit list
3
Experience For Technical Coordinator, Regulatory Reporting Resume
- Continually seek and propose opportunities to improve processes and procedures
- Serve documents to service lists in compliance with CPUC Rules of Practice and Procedure or FERC regulations
- Support faculty, trainees, staff, and others in preparing, finalizing, and submitting timely and complete applications and authorizations including: new projects, amendments, modifications, deferrals, partial HIPAA waivers, continuing review reports, safety/adverse event or deviation reports, and IND/IDE applications
- Obtain and organize other essential documents necessary for study approval
- Maintain electronic and hard copy regulatory files for assigned studies, including human subjects training certificates and financial conflict of interest reporting
4
Experience For Global Regulatory Sciences Coordinator Resume
- Coordinates the production, filing, distribution and posting of regulatory documents, including testimony,
- Collects, analyzes and aggregates data for reporting to committees for: National Patient Safety Goals and Regulatory Compliance Monitoring
- Assists Quality Director and Quality Manager in preparing and coordinating tri-annual QRS survey and follow up as directed
- Participates and assists in creating plans of correction and performance of compliance monitoring in response to regulatory surveys
- Coordinates annual Joint Commission ICM (Intracycle Monitoring) survey and monitors measures for success
- Communicate timelines and/or impact of approvals to research team operations
- Institutional administrator for Clinicaltrials.gov
5
Experience For Regulatory Case Coordinator Resume
- Apply for and maintain NIH Certificates of Confidentiality for studies as needed
- Stay up-to-date on IRB policies and processes to ensure accurate and timely submissions
- Assist with the completion or management of internal and external forms related to clinical trials, including but not limited to UAccess Research (UAR), Research Intake Form, FDA Form 1572, Banner Routing Forms, etc
- Coordinates and implements tracer methodology for standard compliance: Joint Commission, CMS, ISDH, and other regulatory bodies
- Coordinates accreditation activities. Meets with Joint Commission Chapter Captains on a regular basis to facilitate changes and standard compliance. Follows up to ensure standard compliance maintenance
6
Experience For Global Regulatory Transaction Review Program Coordinator Resume
- Maintains up to date knowledge of all standard and regulation revisions and provides continuous education for the hospital and medical staff
- Works with Policy Coordinator to ensure all policies are survey ready and standard compliant
- Performs chart reviews/aggregates/data/prepares reports for standards compliance activities, Medical Staff Committee, and Board of Trustees
- Assists with Serious Event Analysis and Failure Mode Effects Analysis by gathering supporting documentation and participating in action planning, and performing compliance monitoring as assigned
- Participates and assists in Joint Commission and Indiana State Department of Health surveys
- Ensure that final documents are accurate and complete and that confidential information is properly identified
List of Typical Skills For a Coordinator, Regulatory Resume
1
Skills For Coordinator, Regulatory Compliance Resume
- Interface with GRS, Procurement, and Legal to ensure that studies are initiated and conducted under current, valid MSAs and SOWs
- Valid driver’s license, a dependable vehicle & periodic local travel required
- Project management, legal, administrative/clerical, customer service or related experience
- Experience in the White Oil/Food regulatory field
- Provides administrative support related to document control requirements including filing of master documents, formatting and typing of various document
- Assist in submission of Investigational New Drug (IND) applications including amendments and reporting
- Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits
- Coordinates all regulatory and research compliance quality audits and inspections which includes billing and non-billing
- Attends regulatory and administrative meetings for taking and typing of minutes, reports and summaries
2
Skills For Coordinator Regulatory White Oils & Food Resume
- Communicate clearly with regulatory agency staff and interveners regarding the status of data request responses, or responding to routine inquiries or requests
- Multi-task while monitoring multiple projects simultaneously
- Oversee all GRS P-card expenditures and related record-keeping for Director’s approval
- Knowledge of charging and charge master Knowledge of CMS/other applicable regulatory requirements
- Knowledge of working functions of medical records
- Responsible for completing audit of narcotic order forms
3
Skills For Technical Coordinator, Regulatory Reporting Resume
- Create Excel, PowerPoint, and Word documents and presentations utilizing data or input provided by staff
- Screen incoming calls/inquiries and handle independently where possible
- Provide clerical and filing support
- Assist the case manager with ensuring that case participants are aware of case schedules
- Enhanced reporting to stakeholders
- Provide coordination support for filings before the CPUC. Coordinate the production, filing,
- Supports TriNet’s attorneys and specialists in PEO licensing and annual report requirements with federal and state agencies
- Serves as company coordinator to manage ongoing data necessary to complete annual reports in partnership with Corporate Creations
4
Skills For Global Regulatory Sciences Coordinator Resume
- Maintains revision logs and tracking versions of the documents
- Provides accurate filing of pertinent regulatory documents
- Participates in planning functions
- Acts as liaison coordinating tasks/deadlines between the Clinical Research ARC and the Branch
- Assist the case manager with ensuring that team members and witnesses follow Regulatory Affairs’ regulatory processes and procedures
- Schedule team meetings and meetings/workshops with regulatory agencies and/or other parties in a proceeding
5
Skills For Regulatory Case Coordinator Resume
- Draft proposal language and protocol guidance regarding human subject protections
- Occasional travel. (Estimated travel 5-15%)
- Administer and provide support to GRS Director, Managers, and scientists, Corporate Procurement, and Legal for Master Service Agreements (MSAs) and SOWs for all work with external CROs and consultants
- Work with Procurement and Legal to maintain library of current vendors and MSAs
- Utilize study identification information and SOWs to create and execute SOWs
- Archive e-copy and paper as needed of MSAs and SOWs
6
Skills For Global Regulatory Transaction Review Program Coordinator Resume
- Knowledge of ICD~9, ICD~10, CPT codes
- Work multiple tasks in a diversified environment
- Travel as needed to Advocate Health Care facilities
- Flexible to learn other functions within the compliance department
- Communicate with senior leadership team and other key business partners
- Coordinate global travel, bookings, conferences, and other external and internal events
- Maintain confidentiality of projects and work
- Assist with coordination of meetings at tradeshows for executive staff members, as appropriate
7
Skills For FAA / FCC Regulatory Compliance Coordinator Resume
- Handle directed and routine external mail
- Coordinate departmental staff meetings
- Able communicator who is able to discuss RDM’s work with people at all levels of the GCO
- Handle large volume of detailed work with extreme accuracy
- Problem solve quickly
- In regulatory affairs
8
Skills For CMC Regulatory Sciences Coordinator Resume
- Quality Assurance Monitoring for Cancer Center Investigator-Initiated, multi-site trials at main campus, Cleveland Clinic regional sites, and external sites in North America
- Extensive sitting and frequent walking, occasional lifting or carrying up to 25 pounds
- Provide financial analyses, updates, and support to Global Regulatory Sciences (GRS) team, R&D Finance, Tax and Accounting
- Monitor Gateway (global study initiation e-process) to identify new GRS and Area studies that need to be conducted by GRS. Work with GRS Team Managers to identify and track costs and timing for GRS, R&D, and Area studies
- Provide quarterly and year-end actual spending and accruals on all open SOWs for financial accountability to provide accurate spend /forecast data with supporting documentation
- Oversee study start-up activities to including reporting and communicating with stakeholders on a regular basis
- Completes industry registrations and study feasibility questionnaires including receipt, tracking and correspondence with Sponsor/CRO/ARO
- Regularly checking open order reports for non-compliant supplies
- Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution
9
Skills For Lead Coordinator Regulatory Affairs Resume
- Monitor approval status of open studies by completing timely reviews
- Maintain master files of all regulatory-related documents
- Significant improvement in the regulatory examination process
- Timely responses to information requests from regulators
- Experience preferably in a risk management, internal audit, operational risk, legal and compliance role in an investment or large commercial bank, accountancy/consultancy firm or regulator
- Develop and/or monitor case schedules and issues and alert the project management team of issues that require immediate attention. Develop and maintain team SharePoint sites
- Schedule team meetings and maintain a log of key issues and outcomes. Communicate with witnesses and subject matter experts to ensure that work products are completed according to schedule
- Provide coordination support to prepare team for hearings – schedule witness training sessions; assist witnesses in preparing witness binders, gather documents required for hearings
10
Skills For Regulatory Research Coordinator Resume
- Two years working in a clinical environment
- Data Management: Develop the ability and knowledge of creating and changing SAP master data in the areas of Material Master, BOM’s, Routes, QM Plans and other required areas. High volume of data entry required
- Administration of the matter management system and internal shared drive in their use as the department’s document management system
- Triage work on inquiries directed to TriNet’s legal department related to regulatory and PEO compliance
- Provide professional/technical guidance to various TriNet departments on matters related to the company’s licensure requirements and pending regulatory matters
- Experience in document control in a regulated environment
- Ensure mock funds are prepared and procedure documents are maintained prior to on-boarding of new clients. Point out issues/exceptions observed and resolved these accordingly with Home Location’s assistance
- Point out issues/exceptions observed and resolved these accordingly with Home Location’s assistance
- Assists with establishment of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with GCPs, external regulatory agencies and central research administration offices
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