Role Description The Associate Clinical Service Liaison (CSL) serves as a key point of contact between internal teams and external stakeholders, supporting the delivery of high-quality clinical services throughout the genetic testing process. Responsibilities include: - Addressing client inquiries by phone, email, and other communication platforms. - Coordinating communication among internal teams. - Ensuring accurate documentation of patient and provider interactions. - Collaborating across departments to advance team objectives and uphold best practices in clinical service delivery. Job Responsibilities - Provides clinical customer service by facilitating communication between internal teams, healthcare providers, and clients to support timely and accurate case resolution. - Answers clients’ clinical questions regarding incoming samples, ongoing testing, result interpretation and/or variant classification. - Communicates with clients to resolve clinical issues related to test orders. - Manages routine cases at specific steps or throughout the testing process, ensuring appropriate escalation and follow-through. - Assumes personal responsibility for routine administrative tasks and supports team efforts aligned with corporate and departmental Objectives and Key Results (OKRs). - Demonstrates proficiency in internal systems to track, document, and communicate case progress. - Maintains high quality client support with accuracy and meets workload targets with attention to detail and professionalism. - Meets or exceeds productivity standards as assigned by team lead. - May serve as a subject matter expert for designated genes, disorders, tests, or workflows, offering guidance and insight to internal and external stakeholders. - May review and abstract clinical information provided by clients for phenotype-driven testing into GeneDx software. - May contribute to the development and clinical review of materials for websites, marketing, or other cross-functional projects. - Perform other duties as assigned to support the team or department. Qualifications - Master’s degree from an accredited genetic counseling program. - Proven ability to work independently and cross-functionally. - Excellent verbal and written communication skills. - High proficiency in internal systems and Microsoft Office 365 applications. - Demonstrated professional-level proficiency in mathematical reasoning, computer literacy, and language-based communication. - Prior clinical or laboratory experience preferred but not required. Requirements - For Genetic Counselors, Certification by the American Board of Genetic Counseling (ABGC). - Licensure is required in the state where the employee works, if applicable; additional state licenses may be requested based on organizational needs. Physical Demands - Prolonged periods of sitting or working at a computer in a home office environment. - Occasional need to lift or move materials or equipment weighing up to 20 pounds during travel or team visits. Work Environment - Frequent use of digital communication platforms (e.g. video conferencing, email, collaboration tools). - Ability to focus and manage complex tasks in a remote setting with multiple concurrent priorities. - May require occasional travel to laboratory sites, corporate offices, or conferences (typically <10%). Benefits - Paid Time Off (PTO). - Health, Dental, Vision and Life insurance. - 401k Retirement Savings Plan. - Employee Stock Purchase Plan. - Employee Discounts. - Voluntary benefits. - Programs for parents and parents-to-be, including up to 22 weeks of fully paid parental leave (U.S.) and up to $25K annually for fertility, adoption, or surrogacy.

Role Description Looking for dedicated and passionate physicians who want to deliver world-class care. Start a New Career in Wound Care! This career provides high satisfaction while achieving a great work-life balance. Hello fellow physicians!!! If you are passionate about wound care and want to work hard without sacrificing your life, then call us today to join our one of a kind medical group. Skilled Wound Care prioritizes work/life balance for physicians, allowing doctors to choose their own schedule, have 4-5 day work-weeks, no nights, no weekends, no Holidays, and focus their time on surgical procedures instead of admin work. Find a career with us even if you are not Board Certified/Eligible! We train all of our Physicians to become the best in wound care and start a new career! Qualifications - Must have an active Medical License. Requirements - Currently looking for a minimum of two full weekdays. - Full-time Monday through Friday physicians will receive priority consideration due to the magnitude of elderly care that's needed. Benefits - Choose Your Own Schedule - 2-5 Day Work-Week - Free Weekends - Protected Time-Off - No Calls - Full malpractice insurance - Equipment - 2 Fully covered weekend educational retreats per year with 16 hours of CME each - Work in Your Community - Yearly and quarterly bonus potential based on performance - Independent Contractor, Fee for Service Pay Model Company Description We are a nation-wide mobile surgical practice, focused on skin, wound, and ostomy patient issues in home and nursing home settings. Since 2007, Skilled Wound Care has been innovating mobile medicine delivery in the home and the nursing facility. This would set you up to become an expert in your field and highly advanced in your subspecialty. We provide mentoring, professional guidance, covered advanced wound care, and surgical training and on-boarding. To learn more information contact us today at (310) 445-5999! Or visit us at www.skilledwoundcare.com

• Develop statistical methodologies, protocols, and sample size calculations for pre-market and post-market clinical studies. • Plan methods to collect data and develop or review case report forms to ensure compatibility with plan design. • Evaluate reliability and validity of source information, apply weightings to raw data, and organize results in form appropriate to software requirements. • Designs clinical trials, analyzes study data to validate device safety and efficacy, and creates Statistical Analysis Plans (SAPs). • Perform advanced statistical analyses using appropriate methodologies. • Interpret results and provide strategic insights. • Review clinical literature and analyze Real-World Evidence (RWE) to set performance goals. • Write reports summarizing trial outcome statistics, indicating sources of data and limits on reliability and usability, for in-house, regulatory and publication target audiences. • Prepare statistical reports for regulatory submissions (FDA, CE Mark, other regulatory authorities like TUV) and address regulatory inquiries. • Performs analysis and generates visual/tabular data for scientific presentations and publications. • Collaborate with cross-functional team members (clinical affairs, data management, pre-clinical and R&D engineers) to define endpoints, analyze safety reporting, and prepare for submissions.to ensure data integrity and accurate analyses. • Develop statistical tables and data summaries as needed. • Review project database structures, edit checks and data management coding conventions. • Ensure compliance with industry standards and guidelines. • May attend relevant scientific and/or medical meetings. • Support publication of study findings.

Role Description Ora’s Clinical Documentation Management Specialists II (CDMS II) is responsible for the management, quality and oversight of the electronic Trial Master File (eTMF) associated with all phases of assigned clinical trials (i.e., set-up through final transfer / archival). CDMS II’s are crucial for ensuring Ora’s clinical teams operate in compliance with SOPs and processes, study sponsor expectations and all applicable regulations. This role will focus on the quality of documents being uploaded to the eTMF and monitoring compliance to the TMF relative to inspection readiness and handle such issues independently and with oversight for escalations as needed. Additionally, our CDMS II’s have the responsibility of preparing documentation required for regulatory agency inspections and internal audits. This role reports directly to the Manager while working in collaboration with various clinical study teams such as Quality Assurance, Chemical Manufacturing Control, and Medical Devices. Ora’s CDMS II’s will train to become Veeva Vault Super Users and be responsible for providing support and training to more junior team members, identify process improvements, handle escalations for documentation resolutions. What You’ll Do - Implement and administer Ora document management systems (Veeva Vault) and related procedures. - Manage documentation to ensure organization and accuracy. - Ensure clinical records are filed in a timely manner. - Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF. - Assist with the development of work processes and systems to support document management. - Train towards and actively serve as a Veeva Vault Super-user. - Develop and present training materials to educate trial team staff and CDMS I’s. - Assist the clinical team in the close-out and archiving of clinical documentation and reports. - Process and fulfill document requests from internal and external stakeholders. - Generate/review metrics reports intended as periodic review of study files for completeness. - Identify and classify documents or other electronic content. - Prepare and record changes to eTMF documents. - Assist in the development of document or content classification taxonomies. - Assist in the preparation of support documentation and training materials for end users. - Support assigned TMF corrective action plans. - Clear and sustained demonstration of the Ora Clinical’s Values. - Travel Requirements less than 10%. - Adhere to all aspects of Ora’s quality system. Qualifications - Bachelor’s degree with a minimum of 3 years’ experience with clinical documentation. - 3 years’ experience with record management systems (eTMF) in the clinical research field or equivalent combination of work experience, education, and training. Requirements - Prior experience with Veeva Vault, Montrium, Master Control, Documentum, Box is strongly preferred. - Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives. - Familiarity with eTMF and CTMS software for document management activities. - Prior experience working in a CRO environment. - Familiarity with various aspects of clinical trials and regulatory submissions. - Detailed knowledge of regulatory requirements and ICH/GCP guidelines. - Demonstrated ability to work independently, take initiative, and mentor other team members. - Requires strong attention to detail and document organization skills. - Ability to communicate at multiple levels both internally and externally. - Multi-lingual communication is a plus. Benefits - Comprehensive healthcare options in Medical, Dental and Vision beginning day 1. - Flexible PTO & Unlimited Sick Time. - Competitive salaries along with a 401K plan through Fidelity with company match. - Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. - Company Paid Life & Disability Insurance. - Remote & Wellness Reimbursement. - Employee Assistance Program. - Continued opportunities to grow and develop your career journey. - Opportunities to work with colleagues across the globe. - A chance to research new ophthalmic therapies that will impact patients across the globe.