Regulatory Analyst 1

by Irma Moore | Sep 16, 2024 | Uncategorized

Current Employees:

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Remote Regulatory Analyst 1.  

CORE JOB SUMMARY:

The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting the on-site audits, reviewing consolidated records (the results of the records once the new data are added), designing, reviewing and testing the revised treatment matrix which will identify possible cancers from claims data. The RA1 will facilitate the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors. Provides regulatory support for multiple clinical trials from study start-up through study closure. Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions.   Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures and safeguards University assets. Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.

CORE JOB FUNCTIONS:

• Analyzes regulatory requirements, identifying potential conflicts, and has thorough knowledge and ability to apply federal regulations and University policies.

• Oversees accurate and timely processing, tracking and filing of submissions to and actions which includes monthly notifications on submissions for federally mandated deadlines.

• Assists with drafting, preparation, and presentation of programs to investigators and their research staff to raise and maintain knowledge and awareness of research compliance.

• Provides support to investigators by reviewing submissions for content.

• Sends decision correspondence to appropriate parties requesting information.

• Maintains accurate databases generate letters, develops and maintains templates, creates files, and mailing notices.​

Develops and maintains templates, creates files, and mails notices. Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS:                                                                                        

Education: Bachelor’s degree in relevant field

Experience:  Minimum 1 year of relevant experience

Any relevant education, certifications and/or work experience may be considered

Department Specific Functions

DUTIES & RESPONSIBILITIES:

Job duties will include, but not be limited to:

Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.

Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e., local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required.

Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations.

This process will take place from study start-up throughout the completion of the study.

• Initial IRB application

• Amendments / modifications

• Reportable new information
• Protocol deviations / violations
• Protocol exceptions
• IND safety letters
• Continuing and final reports
• Other communications from the sponsor requiring IRB submission.

• Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.

• Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
• Maintains department credentialing information and research records for clinical trials within institution’s electronic systems (e.g., Velos, Complion) and appropriate drives, as applicable.
• Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.
• Communicate with Clinical Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit.
• Assist in the collection and maintenance of credentialing information for study personnel (e.g., study-specific training, IBC, EHS requirements, etc.).
• Upkeep of departmental trackers with study updates to ensure study team personnel are effectively alerted of initial study approvals and IRB approved study and consent amendments.
• Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes facilitation of training and notification of required re-consenting in collaboration with the clinical team following approval of study modifications.
• Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.

• Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request. This responsibility is sponsor dependent. The following documents may be included:
• Financial Disclosure Forms
• FDA 1572
• Initial Protocol Signature Page
• Amendments signature page
• Investigators CV and Medical Licenses
• Laboratories normal ranges and certifications
• IRB approvals
• Approved consents
• Other documents as required by the sponsor

• Provide feedback to Regulatory Management on opportunities for regulatory process improvement.
• Identifies and escalates issues before they become critical.
• Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.
• Other duties as assigned by senior management.

Education:

• Bachelor’s degree
• In lieu of bachelor’s degree, years of relevant experience in clinical research, compliance, research, or a medical setting may be substituted for the educational requirement.

Certification and Licensing:

• Not required

Experience:

• Minimum one (1) year of relevant experience in compliance, research, or a medical setting.
• Experience in clinical trials is preferred.

Knowledge, Skills and Attitudes:

• Skill in completing assignments accurately and with attention to detail.
• Ability to communicate effectively in both oral and written form.
• Ability to handle difficult and stressful situations with professional composure.
• Ability to maintain effective interpersonal relationships.
• Ability to understand and follow instructions.

#LI-YC1

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida’s only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We’re the challenge you’ve been looking for.

Patient safety is a top priority. As a result, during the Influenza (“the flu”) season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer – Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Principal Application Engineer

by Irma Moore | Sep 16, 2024 | Uncategorized

Discover. A brighter future.

With us, you’ll do meaningful work from Day 1. Our collaborative culture is built on three core behaviors: We Play to Win, We Get Better Every Day & We Succeed Together. And we mean it — we want you to grow and make a difference at one of the world’s leading digital banking and payments companies. We value what makes you unique so that you have an opportunity to shine.

Come build your future, while being the reason millions of people find a brighter financial future with Discover.

Job Description:

Discover will not sponsor or transfer employment work visas for this position.  Applicants must be currently authorized to work in the United States on a full-time basis.

Uses vast repertoire of delivering high impact software solutions to work intuitively. Speed comes from intuition. If something breaks you know where to look. Typically does the tough parts – e.g. (re)design and spends more time documenting than coding. Actively manages and escalates risk and customer-impacting issues within the day-to-day role to management

Responsibilities

• Work closely with application development, Architecture, Infrastructure and Engineering teams for test planning, analysis requirement, and for defining success criteria.
• Provide Technical and Application support on Connex Switch 
• Construct and Maintenance of test Environment.
• Prepare test plan, test methodologies and test setup.
• Execute required test on each release and submit test report on time.
• Prepare and present the test reports and metrics clearly to the project team.
• Logging issues and follow up to get the fix.
• Creates technology solutions addressing high impact business priorities. Demonstrates the ability to analyze, design, code, test and deploy solutions and product features with high quality to production. Level of technical expertise enables solutions with high complexity and depth.
• Competent in multiple technical domains, including programming languages, security, automation, testing, and business domains. As a result, is the go-to person for many people outside of their team.
• Participates in strategic technology decisions and understands how these decisions impact Discover as a whole.
• Proactively identifies and mitigates issues based on intuition and experience in multiple domains. Is a thought leader amongst team members and drives problem solving to determine root cause.
• Coaches technology communities at Discover in areas of specific technology domain, design-thinking, agile software development way of working, security, architecture and/or data engineering.

Minimum Qualifications

Here’s what we need from you:

• Bachelor’s degree in Computer Science, Engineering, Informatics, Information Security, Information Technology, or related.
• 6+ years of experience in Information Technology, (Software) Engineering, or related.
• Internal applicants only: technical proficiency rating of proficient on the Dreyfus engineering scale

Preferred Qualifications

If we had our say, we’d also look for:

• At least 6-8 years of working experience with Connex on HPE NonStop and Connex Environment Database
• Knowledge on Card Payments and EFT
• Familiar with different ISO8583 formats like Visa, MasterCard, NYCE, STAR, EPOC, AFFN, PULSE
• Hands-on experience on using Paragon WebFASTest. Ability to build and configure test scripts and simulate various transactions like ATM, POS, EMV Contact & Contactless and Magstripe. 
• Good to have knowledge and prior experience on ATM, POS and EMV transactions.
• Familiar with settlements, reports and reconciliation.

External applicants will be required to perform a technical interview.

Weekend Writer

by Irma Moore | Sep 16, 2024 | Uncategorized

Help manage the weekend operations of one of the world’s biggest knowledge sites. Live Science covers everything from the latest Earth, animals and space discoveries, to groundbreaking research.  and fascinating breakthroughs that impact you and the wider world. We’re looking for someone to boost our weekend coverage of the fascinating science breakthroughs that impact the world.

What you’ll do…

As the Weekend Writer you will pick up breaking news, writing occasional features, posting on social media and ensuring both sites remain engaging and have fresh content throughout the weekend. You will report to the Weekend Editor and work remote.

• Write 3-4 fresh stories per weekend, whether that be short news or longer features
• Create engaging and timely content for Live Science over the course of every weekend.
• General editorial responsibilities and working with the content team

Experience that’ll put you ahead of the curve…

• An in-depth knowledge of space, science and nature
• Experience in a content role on an editorial website
• An inquisitive mind, looking to enhance the way we approach content
• CopySub-editing/proofreading skills
• An understanding of digital media
• First-rate knowledge of editorial SEO and analytics toolspackages
• Proven ability to produce high-quality, engaging, relevant digital content

What’s in it for you… 

We have several awesome perks available to our staff. We offer huge opportunities to learn and develop, whether through professional qualifications, exposure to incredible business projects or informal lunch & learns, hosted by your colleagues. We have a fantastic culture where we really do care about our people and want everyone to succeed. Varied roles mean you’re not pigeonholed into one finite area but you can develop many skills.

And to top it all off, not only do we offer unlimited holiday because we trust you to manage your workload and time but we also offer a share in our success whereby every colleague is eligible to join our profit pool bonus scheme – if Future hits their performance targets all colleagues may receive a bonus.

Internal job family level E7

Please note, the hourly range for this position is $20-$24 per hour.

This is a position covered under a collective bargaining agreement between Future US, Inc. and the Writers Guild of America East.

Who are we…

We’re Future. We’re 3000+ colleagues over 250+ brands speaking to 400 million people every month across the globe through websites, events and magazines. We’ve got ambitious plans that build on our growth momentum and unlock new opportunities and we’re looking for talented people who want to be a part of it.

Our Future, Our Responsibility – Inclusion and Diversity at Future

We have a voice and we’re going to use it. We promote diversity and inclusion not just in our recruitment processes, but everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplaces are inclusive, positive, free of discrimination and respecting of all backgrounds and beliefs. Our culture is underpinned by our values and employees – our – are treated with respect and fairness.

Please let us know if you need any reasonable adjustments made so we can give you the best experience!

Find out more about Our Future, Our Responsibility on our website.

#LI-JM1 #LI-Remote

Requirements

Benefits

IT Solution Owner

by Irma Moore | Sep 16, 2024 | Uncategorized

Primary City/State:Phoenix, Arizona

Department Name: IT Clinical Care-Corp

Work Shift: Varied

Job Category:Information Technology

Good health care is key to a good life. At Banner Health, we understand that, and that’s why we work hard every day to make a difference in people’s lives. Do you like the idea of making a positive change in people’s lives – and your own? If so, this could be the perfect opportunity for you.

This position will lead the IT Integrated Health Solutions Radiology Information Systems team, which supports Cerner RadNet, Fuji RIS, and Volpara Mammography Reporting and other workflows across the Radiology Information Systems space.  We are looking for a strategic thinker that can partner with operational leadership to support the service line and offer solutions.  The location for this role will be primarily remote, although you may be required to work onsite occasionally for strategic planning meetings, go-live support and other duties as needed.

The typical schedule for this role is Monday-Friday 8am-5pm.

Minimum qualifications: 3 years in HealthCare IT or similar, Previous experience with Cerner RadNet and/or Fuji RIS

Preferred qualifications: Previous leadership experience, previous relevant clinical experience.

This is a fully remote position and available if you live in the following states only: AK, AR, AZ, CA, CO, FL, GA, IA, ID, IN, KS, KY, MD,MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WV, WA, WI & WY.

Your pay and benefits are important components of your journey at Banner Health. This opportunity includes the option to participate in a variety of health, financial, and security benefitsYour pay and benefits are important components of your journey at Banner Health. This opportunity includes the option to participate in a variety of health, financial, and security benefits. In addition, this position may be eligible for our Management Incentive Program as part of your Total Rewards package.Within Banner Health Corporate, you will have the opportunity to apply your unique experience and expertise in support of a nationally-recognized healthcare leader. We offer stimulating and rewarding careers in a wide array of disciplines. Whether your background is in Human Resources, Finance, Information Technology, Legal, Managed Care Programs or Public Relations, you’ll find many options for contributing to our award-winning patient care.

POSITION SUMMARY
This position is responsible for planning, organizing and day to day management of information technology projects, applications and professionals. Incumbent participates in the development and implementation of information technology strategies to achieve desired outcomes. Incumbent is expected to work with management across diverse areas and multiple states to pursue system wide solutions and approaches.

CORE FUNCTIONS

1. Business Outcomes: Relentless focus on delivering outcomes and value to our business. Coaches staff regarding enhancements to plans and implementations based on extensive experiences in the industry and a wide breadth of knowledge regarding clients’ operational needs. Identifies strategic level initiatives through input from staff, vendors, and clients. Regularly meets with senior clients to discuss changes in the business and shares potential opportunities in the business. Develops tactical and strategic initiatives to proactively address client needs.

2. Technology Standards: Participates in the design, direction, and coordination of information technology projects, systems or applications. Ensures that department and company standards are implemented and consistently adhered to, ensuring current and future reliability and functionality. Collaborates with business partners and clients on key business issues and plays a part in the making process. Offers constructive advice on business processes, functions, and re-engineering opportunities resulting from the implementation of technology. Can present broad, complex information and concepts in an influential or persuasive way that results in action.

May conduct project planning for assigned work streams following the current selected methodology including: managing tasks, deliverables and milestones; identify and track project issues, risks, decisions and action items; will perform weekly status updates and update team dashboards; manage changes to plans through change controls and re-base lining processes; plan & schedule meetings as necessary, create agendas and documenting minutes; help prepare work stream deliverables.

3. Innovation and Futures: Participates in feasibility studies, request for information/proposal (RFI/RFP) assembly, return on investment (ROI) calculations, capital or operating budgets or other high-level strategic planning sessions.

4. Advisor and Partner: Sets enhanced objectives for self and others. Monitors performance trends and identifies opportunities to improve standards. Provides regular feedback and suggests alternative approaches necessary to ensure that organizational objectives and superior standards are achieved. Delegates responsibility and reallocates resources, as needed, to ensure that priorities are met.

5. Communication: Presents information or ideas to the interests, level and needs of the audience. Actively engages participants and encourages input. Uses group process skills to ensure that the agenda is met. Promotes and facilitates free and open communication. Adapts choice of language and presentation of ideas to fit various needs and perspectives of audiences.

6. Measurements: Proactively plans development and mentoring activities for direct reports. Identifies opportunities for hands-on work that might enhance the growth of others and facilitate the process. Frequently shares own experiences with direct reports and others for the purpose of improving their personal and professional development.

7. Strategic/Leadership: Hires, trains, conducts performance evaluations, and supervises the workflow for designated staff. This includes initiating promotions, transfers and disciplinary actions. This includes establishing priorities, workloads, controls and work procedures, as well as determines resources needed.

Participates in change programs by planning implementation activities with other change champions. Interprets the meaning of new strategic directions for the work group and sets objectives and standards. Implements monitoring and feedback systems. Evaluates progress and finds ways of making continuous improvements. Solicits and offers ideas for improving primary business processes. Improves effectiveness and efficiency through the involvement of peers and business partners by initiating new approaches.

8. Customer Service: Thinks proactively and independently about clients’ needs and collaborates with clients to develop best approaches to certain issues. Synthesizes the needs of multiple customers in the coordination of complex multiple services. Participates and may lead task forces to plan, implement, and coordinate facility activities to maximize service quality, effectiveness and efficiency.

9. This position has company wide responsibility for selected information technology projects, systems or applications. Work is performed in a fast paced multi-tasked environment where there may be conflicting priorities or tight deadlines. The incumbent has decision-making authority for projects and applications and works at peer level with management across diverse areas and multiple states. The incumbent participates in meetings, presentations, visioning sessions, strategic and planning sessions, implementation activities, and supports functions system wide. Maintains and applies a broad knowledge of company policies, procedures, and legal and regulatory requirements.

MINIMUM QUALIFICATIONS

Must possess strong knowledge as normally obtained through the completion of a bachelor’s degree in related field plus progressive experience in a healthcare environment, or equivalent combination of relevant education, technical, business and healthcare experience typically achieved in seven plus years.

Must demonstrate substantial knowledge of information technology, healthcare, and/or operations for an assigned specialty area. Needs significant proven leadership experience in large scale project planning, reporting, and budgeting. May need experience with specific IT process methodology depending on assigned areas of responsibility.

Requires exceptional communication, presentation, and negotiation skills to engage technical and non-technical audiences. Requires leadership skills with ability to lead, communicate, and interact across facilities and at various levels. Successful candidate will have skills and experience to recruit, mentor, motivate, evaluate, and retain staff.

As is typical in this industry, variable shifts and hours and carrying/responding to a pager may be required.

PREFERRED QUALIFICATIONS

Additional related education and/or experience preferred.

EEO Statement:

EEO/Female/Minority/Disability/Veterans

Our organization supports a drug-free work environment.

Business Intelligence Analyst

by Irma Moore | Sep 16, 2024 | Uncategorized

The company is seeking a highly skilled and analytical Business Intelligence (BI) Analyst to support our commercial organization. This role is essential in driving data-driven decision-making and optimizing business performance. The primary responsibilities will include forecasting, compensation planning, maintaining leaderboards, and managing performance metrics. The ideal candidate will have a strong background in data analysis, with the ability to translate complex data into actionable insights that enhance our commercial operations.

Specific duties include, but are not limited to:

• Forecasting and Data Analysis: Develop, refine, and maintain forecasting models to predict sales performance, revenue trends, and other key business metrics. Analyze sales and market data to identify trends, provide insights, and inform strategic decision-making within the commercial organization. Create and manage dashboards and reports that present data in a clear, actionable format for stakeholders across the organization.
• Compensation Planning: Support the design and implementation of compensation plans that align with strategic goals and incentivize the sales force effectively. Conduct regular analyses of compensation data to ensure alignment with industry standards and to drive desired sales behaviors. Monitor the effectiveness of compensation plans, providing data-driven recommendations for adjustments and improvements.
• Leaderboards and Performance Management: Design, implement, and maintain leaderboards and performance tracking systems to highlight individual and team achievements. Develop and track key performance indicators (KPIs) to measure the success of sales initiatives and individual performance. Regularly communicate performance insights to sales leaders, helping to identify high performers and areas needing improvement.
• Collaboration and Stakeholder Engagement: Work closely with sales leaders, finance, HR, and other stakeholders to ensure the alignment of business objectives with data-driven insights. Provide clear, actionable recommendations to stakeholders based on data analysis, supporting strategic planning and operational decisions. Collaborate with IT and data management teams to ensure the accuracy, consistency, and accessibility of data across BI tools and platforms.
• Continuous Improvement: Continuously evaluate and enhance BI processes, tools, and methodologies to improve the efficiency and accuracy of reporting and analysis. Stay up-to-date with industry trends and best practices in business intelligence, forecasting, and performance management. Provide training and support to commercial teams on the effective use of BI tools and the interpretation of data.

Position Requirements:

• Bachelor’s Degree in Business, Finance, Economics, Data Science, or a related field.
• Minimum of 3-5 years of experience as a Business Intelligence Analyst or in a similar role, preferably within a commercial or sales organization.
  Proven experience in developing and managing forecasting models, compensation plans, and performance management systems.
  Strong proficiency in data analysis tools such as Excel, SQL, Tableau, Power BI, or similar BI platforms.
• 5% Travel may be required.

Preferred:

• Advanced degree or certification in Business Intelligence, Data Analytics, or a related discipline.
• Strong analytical and problem-solving skills, with an exceptional attention to detail.
• Ability to interpret large datasets and translate them into actionable insights for non-technical stakeholders.
• Excellent communication and presentation skills, capable of explaining complex data in a clear and concise manner.
• Strong organizational and time-management skills, with the ability to manage multiple priorities simultaneously.
• Ability to work both independently and as part of a collaborative team environment.

Physical Requirements:

Standard office environment. The employee may be exposed to environmental hazards such as exposure to noise, and travel.

More than 50% of the time:

• Sit, stand, walk.
• Repetitive movement of hands, arms and legs.
• See, speak and hear to be able to communicate with patients.

Less than 50% of the time:

• Stoop, kneel or crawl.
• Climb and balance.
• Carry and lift 10-20 lbs.

Residents living in CA, WA, Jersey City, NJ, NY, and CO click here to view pay range information.

#LI-Remote

Akumin Operating Corp. and its divisions are an equal opportunity employer and we believe in strength through diversity. All qualified applicants will receive consideration for employment without regard to, among other things, age, race, religion, color, national origin, sex, sexual orientation, gender identity & expression, status as a protected veteran, or disability.