Title: Clinical Specialist, CRM - Georgia Location: Georgia - Remote time type Full time Job Description: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution · - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is a field-based position based in Georgia in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. What You’ll Work On Under general direction, the CRM Product Support Specialist provides comprehensive engineering, sales, educational, and technical support. This role responds to field inquiries from physicians, healthcare professionals, patients, and field sales staff regarding CRM (Cardiac Rhythm Management) products. Key Responsibilities: - Clinical Interface: Acts as a clinical interface between the medical community and the business. - Relationship Building: Demonstrates the ability to build and sustain credible business relationships with customers and share product expertise accordingly. - Comprehensive Support: Provides engineering, sales, education, and clinical support in response to field inquiries on an as-needed basis. Demonstrates a thorough command of all CRM products, related product and technical knowledge, trends, and players. - Training and Education: Develops, leads, and/or facilitates training sessions and other programs on CRM products for healthcare professionals. - Sales Support: Provides additional back-up support to CRM Sales Representatives. Required Qualifications - Bachelor’s degree in Bio-Medical Engineering, related field or equivalent healthcare experience. - A minimum of 2+ years of related experience or a program certification from an accredited cardiac training program. - Must have the capability to obtain certification in CRM products. - Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. - Familiarity with cath lab and operating room procedures and protocol - Demonstrate advanced knowledge of cardiac pacing systems. - Must apply engineering skills and abilities to interpret and solve complex clinical problems. - Must possess strong written and verbal communication skills, along with excellent interpersonal, presentation, analytical, and organizational abilities. Additionally, must be able to meet deadlines effectively. - Must be detail-oriented and capable of working independently. - Must be able to collaborate effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals. Additionally, must be capable of managing multiple assignments simultaneously and efficiently. - Must have extensive personal computer skills, including experience with Microsoft Office or equivalent software, for tasks such as graphics, word processing, databases, and authoring programs, to develop presentation materials. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is $61,300.00 – $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Support Services DIVISION: CRM Cardiac Rhythm Management LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 20 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Job Description General Summary: The Clinical Scientist Principal will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will work on cross-functional study teams on design, execution, and monitoring of clinical trials, as well as data interpretation and communication. This role will also serve as a point of contact for investigators in day-to-day clinical study needs. Key Duties and Responsibilities: - Works with cross-functional team with oversight by the Medical Lead to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities. - Conducts medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. - Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. - Analyzes and synthesizes information to assess issues relating to protocol conduct and/or individual subject safety. - Provides clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports. - Develops protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead. - Collaborates with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations. - Represents Vertex to outside personnel in the development of clinical protocols and study conduct - Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors. - Leads literature reviews as needed. - Prepares scientific material for conference presentations or publications. Knowledge and Skills: - In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy); proficient knowledge of biostatistics, GCP, and regulatory requirements for clinical studies. - Ability to make independent, timely and appropriate decisions. - Strong oral and written communication skills to explain difficult information and solid computer/analytical skills. - Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate. - High level of organizational and project management skills. - Flexibility to accommodate changes in team and project needs. - Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy. Education and Experience: - Bachelor's degree in the Life sciences - Typically requires 6 years of experience in clinical or pre-clinical research in the pharmaceutical industry or healthcare setting, or the equivalent combination of education and experience. Pay Range: $138,100 - $207,100 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Department: 38494 Enterprise Pharmacy - Pharmacy: Population Health Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Fully remote position Monday-Friday 8-4:30pm Pay Range $54.90 - $82.35 Position Highlights - Clinical Pharmacist, Value-Based Care & Population Health - Full-Time, 1st shift, Monday-Friday, 8a-430p, fully remote position - Winston Campus How You’ll Impact Patient care: Your responsibilities may include, but are not limited to: - Oversees pharmaceutical care, including retrieving and evaluating biomedical literature and designing medication therapy regimens - Uses effective patient education techniques to provide counseling to patients and caregivers, including information on medication therapy, adverse effects, compliance, appropriate use, handling, and medication administration - Designs, recommends, monitors, and evaluates patient specific pharmacotherapeutic regimens based on relevant biomedical literature. Implements recommendations effectively and utilizes policies and procedures and documents in the appropriate format.  - Reviews and accurately interprets medication orders and prescriptions - Participates in the management of medical emergencies when applicable  - Actively supports department medication safety and quality improvement activities, including the reporting of events through appropriate channels - Performs quality assurance and performance improvement of the medication use system as appropriate - Collaborates with the healthcare team to manage formulary adherence and the medication-use process. Assists in the acquisition of non-formulary, compassionate use, and investigational medications.  - Practices in compliance with organization’s policies and procedures, as well as local, state, and federal regulations - Prepares, dispenses, and oversees the proper storage and handling of medications in accordance with best practice, policies and state and federal regulations  - Serves as preceptor for pharmacy students, residents, and healthcare learners as assigned   - Mentors, orients, trains, and assists with the performance evaluation of pharmacy teammates, residents, and students as assigned - Directs and checks the accuracy of the work of pharmacy support team members in accordance with the organization’s policies and procedures to ensure safe and efficient workflows, service standards, and regulatory compliance - Must be able to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served. Must demonstrate knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient's status and interpret the appropriate information needed to identify each patient's requirements relative to his/her age-specific needs, and to provide the care needed as described in the department's policies and procedures. Age-specific information is developed further in the departmental job standards. What You Will Need: - Graduate of an accredited School of Pharmacy with a B.S. in Pharmacy or Doctor of Pharmacy (Pharm.D.) is required. - Current state pharmacist license in good standing through North Carolina Board of Pharmacy is required. Nice To Have (Not Required): - Completion of an ASHP-accredited PGY1 residency or equivalent experience is preferred. - Strong attention to detail and a commitment to patient safety. - Excellent communication and interpersonal skills. - Ability to work collaboratively in a fast-paced healthcare environment. DISCLAIMER All responsibilities and requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only responsibilities to be performed by an employee occupying this job or position. Employees must follow any other job-related instructions and perform any other job-related duties requested by their leaders. Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including: Compensation - Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training - Premium pay such as shift, on call, and more based on a teammate's job - Incentive pay for select positions - Opportunity for annual increases based on performance Benefits and more - Paid Time Off programs - Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability - Flexible Spending Accounts for eligible health care and dependent care expenses - Family benefits such as adoption assistance and paid parental leave - Defined contribution retirement plans with employer match and other financial wellness programs - Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

Role Description ClinChoice is seeking an experienced Freelance Clinical Research Associate (CRA) to monitor a Phase I oncology trial. This is a full-time (1.0 FTE), remote position for a U.S.-based CRA, with approximately 70% travel to investigative sites. Opened to 1099 independent contractors. - Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned. - Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites. - May act as Feasibility Associate. - Train site staff in all study procedures. - Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF). - Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data. - Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site. - Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues. - Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. - Act as the main contact person for the site to ensure close follow up. - Provide general support to the Clinical Research Division on quality control of clinical data. - Address appropriate team members about any issues that can jeopardize the conduct of the clinical projects assigned in a timely manner. - Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial. - Develop training material and give training in collaboration with the Training & Qualification Management Unit. - May assist with contract negotiation with sites on study budget after appropriate training. - Assist with the preparation of the study, including CRF design/development, write CRF instructions and organize the study files and documents to ensure good start-up of the investigation sites. - May support the submission process in the project including submission requirements, timelines, informed consent development, etc. Qualifications - University Degree in scientific, medical or paramedical disciplines. - Eight (8) years (at least) of experience as a CRA. - Advanced oncology experience required, including experience with Phase 1 oncology trials. - Experience monitoring CAR T studies is required. - Proven experience as a CRA, performing on-site monitoring activities. - Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements. - Fluent in English. - Proficiency in Microsoft Office (e.g., Word, Excel, Outlook). - Willingness to travel 70% of the time. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. - Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. - Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. - Close management and training is the core instrument to develop and maintain highly qualified personnel. - Continuous training keeps the resources qualified in terms of competence and expertise. - We recognize diversity and inclusivity as our strength and celebrate it.