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

Fraud & Payments Support Associate (Seasonal)

by twochickswithasidehustle | Sep 16, 2024 | Uncategorized

Hi, we’re Underdog!

We’re the fastest-growing sports gaming company ever.

We build innovative games and products for American sports fans.

Founded in 2020, our team built four of today’s most widely played fantasy games and recently launched our Underdog Sportsbook. We are the only sportsbook to ever launch on our own home grown technology, which allows us to build different and innovative experiences. We believe there’s so much more to be built for sports fans, and we’ll continue to win by building the best products and experiences for our customers.

The opportunity in front of us to become the biggest company in our space is massive; after all, we’re currently sitting in the fastest-growing consumer industry in the U.S. In just over two years, we reached a nearly $500 million valuation through some of the best investors in the game, including Mark Cuban, Kevin Durant, BlackRock, and SV Angel. We are many times larger now and our growth is not slowing down.

At Underdog, we believe that sports are for everyone and are building a tomorrow for every fan. Want to help create that future? Join us.

About the role:

• Review high volumes of data with meticulous attention to detail and strong analytical skills
• Gather information from users in order to efficiently reach solutions by cross-collaborating with teams from several different departments
• Create a lasting impression on every user through transparent, open, and honest communication
• Identify and implement process improvements within fraud and payment workflows
• Show up everyday with a positive attitude and excited to help the team collectively reach its goals
• Work in a dynamic and fast-paced environment where every transaction handled is critical to our customers’ experience and trust in our platform
• Assist in facilitating a smooth and seamless onboarding experience for users, ensuring their successful adoption of the app

Who you are:

• Flexible weekday & weekend availability due to varying shifts
• An optimistic and proactive individual, dedicated to finding solutions
• A versatile team player, adept at navigating diverse situations with ease
• A clear and concise communicator, with an emphasis on writing skills
• A receptive individual who embraces new perspectives and approaches
• An insatiably curious learner, driven to acquire new knowledge daily
• A customer service expert, delivering exceptional support by showcasing deep product expertise
• Proficient multitasker, committed to delivering high-quality work across various tasks

Even better if you have:

• 1-2 years of fraud support or related experience
• Experience with Intercom (or other ticketing processor systems)
• Fantasy Sports and/or Sports Betting knowledge

Our target starting base salary range for this position is $20/hr, plus target equity. The starting base salary will depend on a number of factors including the candidate’s skills and experience, among other things.  

This position may require sports betting licensure based on certain state regulations.

Underdog is an equal opportunity employer and doesn’t discriminate on the basis of creed, race, sexual orientation, gender, age, disability status, or any other defining characteristic.

Medical Scheduler- Remote

by twochickswithasidehustle | Sep 16, 2024 | Uncategorized

FORM Health is a virtual obesity medicine clinic delivering multi-disciplinary evidence-based obesity treatment through telemedicine. Obesity impacts more than 40% of the US adult population, and although historically only about 1% of patients received medical treatment for their disease, the field of Obesity Medicine is entering a period of rapid growth. FORM provides high-quality expert care and leverages technology to enhance the patient experience. All FORM patients work closely with their care team, which includes board certified physicians, advanced practice professionals and Registered Dietitians. Through our proprietary mobile app patients engage in regular video visits, as well as text messaging, photo journaling, digital data transmission, and customized educational materials. We hold ourselves to the highest standards of clinical care, and to treating every individual with empathy and respect. 

Founded in 2019, FORM is a venture-backed innovative startup with an experienced clinical and leadership team. Our mission is to empower patients and be leaders in Obesity Medicine driving impact at a national scale. We are deeply invested in our core value to put patients first, and also deeply committed to creating a culture where every employee is valued and we learn and improve together. 

About the Role:

We are looking for an experienced Medical Scheduler who excels in a collaborative telemedicine environment. The ideal candidate will have strong interpersonal, critical thinking, and organizational skills and be excited to join a healthcare startup focused on helping patients achieve sustained weight loss for healthier, happier lives. In this role, you will manage high-volume provider scheduling and work with a growing team to improve processes, provide feedback on scheduling tools, and develop best practices. You will also help refine scheduling workflows and implement scalable procedures to ensure smooth operations as we grow. 

This is a full-time, remote position serving patients in the Central/Pactific time zones, with working hours from 10 AM – 6 PM CT or 9 AM – 5 PM PT

Key responsibilities include:

• Manage and schedule new and existing patient appointments to ensure timely scheduling.
• Maintain accurate and up-to-date patient records and appointment schedules.
• Utilize an internal scheduling tool to optimize provider utilization. Assess clinician schedules to determine focus areas and availability.
• Work with practice operations to allocate resources and time slots appropriately.
• Confirm appointments with patients and send reminders. Handle cancellations, rescheduling, and rejoining requests.
• Suggest and implement workflows to enhance efficiency and patient experience.
• File and manage documentation in patient charts, including medical records, prior authorizations, referrals, and determinations.
• Communicate with patients to resolve scheduling issues and troubleshoot any conflicts or concerns.
• Continuously improve scheduling processes to enhance efficiency and support the organization’s growth.
• Implement new procedures to ensure scalability and seamless scheduling operations as the practice expands.
• Perform other duties as assigned

You’ll be successful in this role because you have:

• Minimum of 2 years’ experience in medical scheduling within a high-volume setting. Experience working with multiple providers across states is highly preferred.
• Experience in a startup medical practice is preferred
• Experience supporting Providers in a multi-state telehealth practice.
• Possess Electronic Medical Record (EMR) experience and a solid understanding of medical terminology.
• Exhibits strong organizational skills and effective prioritization.
• Excels in managing tasks individually as well as in a team environment.
• Demonstrates excellent verbal and written communication skills, with experience in both asynchronous and synchronous patient communication.
• Possess strong computer skills, including experience with Google Suite and the ability to work comfortably with custom-built and evolving IT systems.

More about FORM’s benefits:

• Competitive compensation and equity in a high growth start-up
• Comprehensive health benefits (medical, dental, vision) 
• 401k Program
• Flexible work schedules and paid time off
• Paid parental leave

FORM Health’s commitment to building a diverse, equitable, and inclusive work environment:

FORM Health is committed to creating a culture and environment that celebrates diversity and inclusion, while fostering safety and belonging. This extends from our remote patient care to our corporate offices and everywhere in between. We are looking for team members who want to help us further our Diversity, Equity, and Inclusion (DEI) efforts and who share our attitudes for creating an inclusive, safe, and positive work environment.

Hourly Pay Range

$16 – $22 USD

Final Documents Specialist

by twochickswithasidehustle | Sep 16, 2024 | Uncategorized

CrossCountry Mortgage (CCM) is the nation’s number one distributed retail mortgage lender with more than 7,000 employees operating over 700 branches and servicing loans across all 50 states, D.C. and Puerto Rico. Our company has been recognized ten times on the Inc. 5000 list of America’s fastest-growing private businesses and has received many awards for our standout culture.

A culture where you can grow! CCM has created an exceptional culture driving employee engagement, exceeding employee expectations, and directly impacting company success. At our core, our entrepreneurial spirit empowers every employee to be who they are to help us move forward together. You’ll get unwavering support from all departments and total transparency from the top down.

CCM offers eligible employees a competitive compensation plan and a robust benefits package, including medical, dental, vision, as well as a 401K. We also offer company-provided short-term disability, an employee assistance program, and a wellness program.

Position Overview:

The Final Documents Specialist will perform a formal review and inspection of all trailing loan documents to ensure accuracy and completeness within the designated time frame. Follow up via phone or email on pending documents. Record (check-in) documents as they are received and any comments into the database. Manage a working pipeline of loans. Monitor reports to track outstanding documents. File and retrieve documents as necessary and ship to destination. Perform audit on documents received and capture required data elements and comments in the LOS system. This position operates within Eastern Standard Time Zone working hours to support the East Coast region.

Job Responsibilities:

• Receive incoming trailing documents through various mail sources, opens and preps for imaging, scans documents into LOS system and identifies Investor on the loan for determination of mailing the trailing document to the investor.
• Perform data entry in LOS system marking document as received, and enter date shipped to the Investor of record.
• Pull reports from LOS system to identify the aged trailing documents currently outstanding with investors.
• Monitor aged trailing documents in an active pipeline.
• Perform follow-ups with Settlement Companies and Attorneys’ offices to obtain aged missing documents outstanding for delivery to the Investors.
• Obtain Certified True Copies of Mortgage/Deed of Trust from County Recorder Offices and/or final Title Policy copies from Settlement Agents or Attorney’s Offices when determined that the document has been lost or aged.
• Prepare Scrivener’s Affidavits and Assignments as needed and have signed by the Executive Team for recording.
• Monitor and answer general questions being received in the Final Docs Team e-mail box.
• Perform weekly reviews of trailing documents received that were not sold to an investor at time of receipt to determine if an Investor has been assigned for delivery of the trailing documents received
• Work with Investors, Internal departments, and Settlement/Attorney offices to cure defects found in the Mortgage/Deed of Trust or Final Title Policy including re-recording if needed.

Qualifications and Skills:

• High School Diploma or Equivalent.
• One year of residential mortgage experience.
• Knowledge of Ellie Mae Encompass 360.
• Knowledge of Mortgage Loan documents and Title work experience preferred.
• Excellent customer service skills.
• Proficient in Microsoft Word and Excel.
• Must be able to stand for long periods of time and lift up to 25lbs.

Pay Range:

• Base Pay: $18.00 – $20.00
• The posted pay range considers a wide range of compensation factors, including candidate background, experience and work location, while also allowing for salary growth within the position.