Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia. The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with sponsors, attending team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities - Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in Pre/Post-award process. - Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. - Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study. - Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies. - Establishes and maintains research files and documentation pertaining to regulatory requirement for clinical trials. - Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings. - Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date. - Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments. - Participates in required training and education programs and may provide training and education of other personnel. - May participate in centralized activities of the department or institution. - May plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP’s and/or job aids. - May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. - Ensures compliance with all federal and local agencies including the Food and Drug Administraton (FDA) and local Institutional Review Board. - Maintains research practices using Good Clinical Practice (GCP) guidelines. - Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - Provide statistical support for clinical trials from study start-up through final reporting and regulatory submission.   - Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy.   - Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents.   - Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the study lifecycle.   - Review statistical analyses and outputs, including tables, listings, and figures, to ensure quality, accuracy, and consistency.   - Support interim analyses, safety reviews, efficacy analyses, and final study reporting.   - Participate in the review of ADaM specifications, derived endpoints, and analysis datasets.   - Support the preparation of DMC materials, including review of analysis outputs and summaries for DMC meetings, in accordance with applicable procedures and confidentiality requirements.   - Interpret statistical results and communicate findings clearly to internal teams and sponsors.   - Ensure study deliverables are completed on time and in compliance with SOPs, regulatory requirements, and sponsor expectations.   - Support responses to sponsor questions, audit requests, and health authority queries related to statistical matters.   - Provide guidance to junior statisticians and support departmental process improvement and standardization efforts.   - Contribute to proposal development, bid defenses, and budget assumptions as needed.   Oncology-Specific Responsibilities  - Support oncology studies involving endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR.   - Contribute to statistical strategies for time-to-event analyses, censoring rules, subgroup analyses, and sensitivity analyses.   - Support studies using RECIST, iRECIST, or other disease-specific response criteria, as applicable.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - Support statistical activities related to DMC/IDMC reviews for ongoing clinical trials.   - Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials.   - Contribute to DMC charter review and statistical content, where applicable.   - Work effectively within blinded and unblinded team structures and maintain strict confidentiality.

Associate Biostatistician ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Associate Biostatistician to join our diverse and dynamic team. As an Associate Biostatistician at ICON, you will play a pivotal role in analyzing and interpreting clinical trial data, supporting the design of statistical analyses, and contributing to the development of high-quality reports. Your work will be integral to advancing clinical research and ensuring that data-driven insights support the development of innovative treatments and therapies. What You Will Be Doing: - Conducting statistical analyses and generating reports for clinical trials under the guidance of senior statisticians. - Collaborating with clinical teams to design and validate statistical methodologies for trial protocols. - Preparing and presenting statistical summaries and interpretations for regulatory submissions and internal meetings. - Ensuring data integrity and accuracy through rigorous statistical validation and quality control processes. - Assisting in the development of statistical programming and analysis plans in accordance with regulatory guidelines. Your Profile: - Master’s degree in Statistics, Biostatistics, or a related field. - Experience with statistical software such as SAS, R, or similar tools. - Understanding of clinical trial design and statistical methods applicable to clinical research. - Strong analytical skills with a keen attention to detail and accuracy. - Excellent communication skills and the ability to work collaboratively within multidisciplinary teams. #LI-JJ1 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Department: 38524 Enterprise Pharmacy - Virtual Pharmacy Services: Acute Care Status: Part time Benefits Eligible: No Hours Per Week: 0 Schedule Details/Additional Information: PRN Virtual Pharmacy Services for NC/GA. Atrium Health Pharmacists will need to be licensed by Georgia or North Carolina to start and must obtain both NC and GA licenses within 6 months of hire. Must be able to work a Rotating/Variable schedule which includes BOTH 1st AND 2nd shift rotation. Rotating Weekends and Holidays are required. Every 3rd weekend and every 3rd minor and major holiday (2 per year) Pay Range $54.90 - $82.35 Virtual Pharmacists will verify orders for all acute care facilities in the Atrium Health NC/GA Division, including rehabilitation hospitals. There will be Med Surg, Critical Care and Pediatric order verification queues built in Epic. Major Responsibilities: 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. Licensure, Registration, and/or Certification Required: Licensed in the state(s) of practice or eligible for reciprocity required Immunization and non-vaccine injectable certification required based on area of practice Credentialing and privileging required based on area of practice Education Required: Bachelor’s or Doctorate degree in pharmacy from an ACPE-accredited school of pharmacy required, or an FPGEC certificate from NABP Experience Required: No experience required. Two years acute care hospital pharmacy experience, PGY-2 residency or previous hospital experience preferred. Highly effective verbal communication and interpersonal skills with patients, visitors, and other healthcare team members to establish working relationships that foster optimal quality of patient care required. Knowledge, Skills & Abilities Required: Maintains skills in area of practice Strong computer skills Excellent communication and organization skills Excellent presentation, facilitation, and training development skills Demonstrates decision making, team building, customer service, and conflict resolution skills Life support training courses may be required dependent on department discretion Physical Requirements and Working Conditions: Requires considerable walking, standing, pushing mobile cart of 50 pounds maximum and lifting 35 pounds of material without assistance Exposed to various conditions throughout the workday such as walking on hard surfaces, climbing stairs and changes in temperature and humidity May be required to frequently stretch, bend, squat, or kneel to perform job Utilizes appropriate personal protective equipment (PPE) to minimize exposure to hazardous agents Takes necessary precautions to avoid inadvertent needle sticks, minor cuts or bruises Must be able to perform manipulative skills such as writing, typing, and data entry into the computer and automated dispensing machines Must have use of both hands, be able to see clearly and read small font such as that on unit-dose medication packages and syringes Must have functional speech, vision, and hearing Operates all equipment necessary to perform the job Exposed to normal office 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.