Clinical associate jobs near me - 159 jobs

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Clinical Research Associate leads real-world research, market insights, and scientific communication initiatives supporting Healthmark's commercial and clinical strategy. This role designs and executes real-world studies on Healthmark products, analyzes data, monitors FDA safety alerts and outbreak reports, develops scientific publications, and supports presentations and educational content. The position blends research, evidence generation, and science communication to provide data-driven insights that shape product strategy, customer education, and marketplace understanding. Job Responsibilities and Essential Duties: * Design, plan, and conduct real-world studies evaluating Healthmark and Getinge products and other medical devices. * Coordinate market research initiatives to identify customer needs, device performance trends, and marketplace gaps. * Lead data collection, data analysis, and ensure adherence to study protocols. * Perform routine surveillance of peer-reviewed literature, FDA MAUDE reports, outbreak summaries, and regulatory inspection findings. * Synthesize findings into actionable reports, briefs, and recommendations for leadership and product teams. * Write or co-author manuscripts, literature reviews, technical papers, white papers, and industry articles. * Collaborate with the technical writer to prepare publications and educational content. * Support conference presentations, webinars, and professional education materials with scientific research. * Develop internal evidence briefs summarizing research trends and key literature updates. * Partner with Marketing, Sales, Product Management, and R&D on evidence generation and product support. * Represent Healthmark at scientific conferences and professional society meetings. * Management of Key Opinion Leader (KOL) relationships. * Work with R&D and Regulatory to conduct existing product research for regulatory submissions. * Contribute to the creation of training materials, slide decks, and educational programs. Required Knowledge, Skills and Abilities: * Excellent data interpretation and scientific writing abilities. * Strong project-management and organizational skills. * Ability to translate complex scientific findings into clear, accessible communication. * Proficiency with literature review tools, MAUDE database searches, and data analysis software. * Strong presentation and public speaking skills. * Ability to work independently and remotely. Minimum Requirements: * Master's degree in Public Health (MPH), Epidemiology, or related scientific discipline. * 3-5 years of experience conducting real-world or post-market studies in healthcare or medical device settings. * Experience with protocol development, data collection, analysis, and manuscript writing. * Experience with peer-reviewed publication processes. * Strong scientific communication skills, including writing and presenting. * Experience in infection prevention, sterile processing, or medical device reprocessing strongly preferred. * Ability to collaborate cross-functionally across clinical, marketing, regulatory, and product teams. Environmental/Safety/Physical Work Conditions: * 10% travel required. * Sit when needed to do job. * Stand for long periods of time. * Wear PPE when required for the job. * Be able to lift to 25 lbs. The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The salary range for this job is a minimum of $80,000 to a maximum of $110,000 annually, plus 4% bonus potential. About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: * Health, Dental, and Vision insurance benefits * 401k plan with company match * Paid Time Off * Wellness initiative & Health Assistance Resources * Life Insurance * Short and Long Term Disability Benefits * Health and Dependent Care Flexible Spending Accounts * Commuter Benefits * Parental and Caregiver Leave * Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. Nearest Major Market: Detroit

Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at ************************* Castle Biosciences Inc. is growing, and we are seeking to hire a full-time Clinical Research Associate to work remotely from a home-based office in the USA, preferably located in the greater Chicago area, St. Louis, Missouri, Ohio, Virginia, Pennsylvania, Nashville, Indianapolis, or Atlanta within close proximity to a major airport. Why Castle Biosciences? * Exceptional Benefits Package: * Excellent Annual Salary + 20% Bonus Potential * 20 Accrued PTO Days Annually * 10 Paid Holidays * 401K with 100% Company Match up to 6% * 3 Health Care Plan Options + Company HSA Contribution * Company Stock Grant Upon Hire Salary Range: $90,000 - $95,000. Salary Range is based on Experience and Education levels. A DAY IN THE LIFE OF A Clinical Research Associate The Clinical Research Associate (CRA) is responsible for managing sites participating in Castle's clinical studies. Daily tasks vary based on study and site needs and may include attending team meetings, training site staff, sending emails, and traveling to U.S. sites to monitor data. The CRA performs all aspects of clinical monitoring and site management in compliance with ICH GCP, FDA guidelines, local regulations, protocols, and Castle's SOPs. This role ensures protocol and regulatory compliance, manages study documentation, and fosters strong relationships with sites. CRAs also play a key role in protecting participant safety, ensuring data quality, and representing Castle in the broader research community. REQUIREMENTS * Bachelor's degree in a science or healthcare-related field or a registered nursing certification, or equivalent certification/licensure from an appropriately accredited institution. * 3 years of CRC experience or previous 1 year experience as a CRA. * Direct patient care or clinical research experience required. * Familiarity with clinical research and study development processes. * Valid Driver's License where applicable. * In some cases, a combination of education, professional training, and demonstrated experience that provides the required knowledge, skills and abilities may be considered. TRAVEL/WORK ENVIRONMENT * Regular overnight travel by car and air, typically 50-60% of the time, with potential peaks up to 80% * Flexibility to accommodate an often changing and unpredictable timeline * Frequent laptop use * When in the office, there is a standard office environment with the use of a desk/phone/computer * Generally, proof of COVID-19 vaccination will be required to access study sites, in accordance with site-specific guidelines and subject to any applicable exceptions as required by Federal, State, and Local laws. SCHEDULE * M-F travel-based position; working remotely from your home based in the USA near a major airport. * Preferred locations include greater Chicago area, St. Louis MO, Ohio, Virginia, Pennsylvania, Nashville or Atlanta within close proximity to a major airport. READY TO JOIN OUR BIOTECH TEAM? We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon! Castle Biosciences Awards and Research Developments! WORK AUTHORIZATION All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas. ABOUT CASTLE BIOSCIENCES INC. At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development. Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com. This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. No third-party recruiters, please

US Central, Clinical Research Associate, Remote 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 a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 2 years of experience as a Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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

How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level. What will you do? CLINICAL SITE MONITORING Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits Assist with selection of potential investigators Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed Evaluate investigator compliance with the study protocol and applicable regulations Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed Verify and reconcile site's essential documents against the trial master file as required Oversee and conduct monitoring activities, including remote monitoring when applicable Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study CLINICAL SITE MANAGEMENT Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites. Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans Ensure audit and inspection readiness of assigned sites Advise on pre-audit activities for GCP requirements Be familiar with assigned study timelines and communicate potential issues to study management How will you get here? Works independently with minimal supervision Conducts all types of site visits Build strong productive relationships with study investigators, site staff, and study management personnel Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinical research experience Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA Knowledge and understanding of Good Clinical Practices (ICH E6 R2) Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies Must have proficient computer skills and experience with Microsoft Office Must be willing and able to travel approximately 75-80%, including overnight, domestic and international Must have Self-directed behavior #GKOSUS

How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level. What will you do? CLINICAL SITE MONITORING Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits Assist with selection of potential investigators Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed Evaluate investigator compliance with the study protocol and applicable regulations Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed Verify and reconcile site's essential documents against the trial master file as required Oversee and conduct monitoring activities, including remote monitoring when applicable Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study CLINICAL SITE MANAGEMENT Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites. Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans Ensure audit and inspection readiness of assigned sites Advise on pre-audit activities for GCP requirements Be familiar with assigned study timelines and communicate potential issues to study management How will you get here? Works independently with minimal supervision Conducts all types of site visits Build strong productive relationships with study investigators, site staff, and study management personnel Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinical research experience Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA Knowledge and understanding of Good Clinical Practices (ICH E6 R2) Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies Must have proficient computer skills and experience with Microsoft Office Must be willing and able to travel approximately 75-80%, including overnight, domestic and international Must have Self-directed behavior #GKOSUS

Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team! This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our PACE Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary. WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check; * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or science related field; * Experience as a Clinical Research Coordinator (minimum 1 year); * Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Compensation A target salary range of $60,000 - $140,000 with potential for bonus and equity awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). For more details, please discuss with your recruiter. #LI-Remote Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive PTO packages - starting at 20+ days * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Competitive compensation and benefits package * Structured career paths with opportunities for professional growth * Discounts for local businesses Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Careers with real impact. Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter. ABOUT ORSINI Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™ OUR MISSION Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. CORE VALUES At the heart of our company culture, the Orsini LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. COMPENSATION & LOCATION The salary range for this role is $80,000-$90,000. This on-site position based out of our Columbus, Ohio. Travel to other locations may occur, although minimal. POSITION SUMMARY The Clinical Trial Coordinator will oversee and manage the dispensing operations for clinical trials and Early Access Programs for Orsini. This role ensures compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards while coordinating with sponsors, CROs, investigators, and internal pharmacy teams. The position is critical for maintaining accuracy, integrity, and timely delivery of investigational products to trial participants. Essential Duties Serve as the primary liaison between the specialty pharmacy, clinical trial sponsors, CROs, and clinical sites. Provide timely updates on IP status, shipment schedules, and dispensing activities. Coordinate all pharmacy-related activities for assigned clinical trials, including investigational product (IP) receipt, storage, dispensing, and accountability. Ensure adherence to study protocols, sponsor requirements, confidentiality, and regulatory guidelines. Maintain accurate documentation for IP handling, including temperature logs, chain of custody, and dispensing records. Ensure compliance with state and federal pharmacy laws, clinical trial regulations, and specialty pharmacy accreditation standards. Prepare for and support audits and inspections by sponsors, CROs, and regulatory authorities. Manage investigational product inventory, including reconciliation and returns in conjunction with the inventory management team. Implement quality assurance processes to ensure accuracy and prevent protocol deviations. Train pharmacy staff on study-specific requirements and handling procedures. Maintain SOPs and ensure proper documentation for all trial-related activities Disclaimer: The information written in this indicates the general nature and level of work to be performed. This is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description. KNOWLEDGE, SKILLS, AND TRAINING Pharmacy Technician License. Bachelor's degree in Life Sciences, or related field. Minimum 2-3 years of experience in clinical trials or investigational drug services. Familiarity with GCP, FDA regulations, and clinical trial operations. Strong organizational and project management skills. Excellent communication and collaboration abilities. Proficiency in clinical trial management systems and pharmacy dispensing software. NICE TO HAVE'S Certified Clinical Research Coordinator (CCRC) or equivalent. Specialty Pharmacy experience. EMPLOYEE BENEFITS We offer a comprehensive benefits package designed to support your health, financial security, and overall well-being: Medical Coverage, Dental, and Vision Coverage 401(k) with employer match Accident and Critical Illness coverage Company-paid life insurance options Generous PTO, paid holidays, and floating holidays Tuition reimbursement program. Equal Employment Opportunity Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws. Americans with Disabilities Act Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Pay Range: Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements. Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance. Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires. Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently. Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs. Review and interpret diagnostic test results and related documentation required per protocol. Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events. Dispense study medication in a professional and accountable manner following protocol requirements. Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens. Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised. KPA 2 - Regulatory and Data Integrity Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file. Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC. Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests. Implement a CAPA assessment and follow CAPA related issues through to resolution. Escalates issues of protocol non-compliance to study PI and research department leadership. KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance Assess a protocol and study plan to develop a study budget. Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study. Position Qualifications/Requirements Education Bachelors or Associates degree in Nursing is required. Certifications/Licenses Unencumbered RN License in state of employment or multi-state license. Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required. Previous Experience 2-5 years nursing experience required, oncology preferred. Core Capabilities Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment. Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback. Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations. Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites. Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required. Prior experience with electronic medical records (EMR) is preferred. Prior experience with clinical trial data entry systems (EDC) preferred. Prior Clinical Trial Management Systems (CTMS) preferred. Travel: 0% Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM #AONN

Pay Range: Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements. Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance. Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires. Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently. Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs. Review and interpret diagnostic test results and related documentation required per protocol. Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events. Dispense study medication in a professional and accountable manner following protocol requirements. Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens. Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised. KPA 2 - Regulatory and Data Integrity Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file. Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC. Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests. Implement a CAPA assessment and follow CAPA related issues through to resolution. Escalates issues of protocol non-compliance to study PI and research department leadership. KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance Assess a protocol and study plan to develop a study budget. Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study. Position Qualifications/Requirements Education Bachelors or Associates degree in Nursing is required. Certifications/Licenses Unencumbered RN License in state of employment or multi-state license. Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required. Previous Experience 2-5 years nursing experience required, oncology preferred. Core Capabilities Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment. Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback. Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations. Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites. Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required. Prior experience with electronic medical records (EMR) is preferred. Prior experience with clinical trial data entry systems (EDC) preferred. Prior Clinical Trial Management Systems (CTMS) preferred. Travel: 0% Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM #AONN

About the Role The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You'll Be Doing Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract. Acts as a liaison between sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria. Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational Product accountability for accurate compliance. Collects, processes and ships blood/urine specimens at scheduled times. Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study specific procedures, including but not limited to ECG's, vital signs, height, weight, injections etc. within his/her scope of practice. Collect, compile and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol. Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance. Contacts outside health care providers and communicates with subjects to obtain follow up information. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Ensures filing and maintenance of all regulatory documents. Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned. What We Expect from You Associates or Bachelor's Degree from an accredited college or university. Good Clinical Practice (GCP) Certificate International Air Transport Association (IATA) Certificate CCRC certification through an accredited organization (ACRP/SoCRA) is required 2-3 years related Research experience Preferred. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Travel Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected. What We are Offer You At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters” Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more. About US Urology Partners U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy. U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives. Job Responsibilities Clinical Research Project Planning and Preparation Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources. Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study. Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings). Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following: o Clinic logistics planning, schedule of clinic activities, and team training. o Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules. o In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study. o Confirms all required regulatory and contractual documentation is present prior to study start. Support the Principal Investigator as needed with study related tasks such as, but not limited to: o Delegation of Authority Log. o Management of daily tasks. o Visit calendar development and maintenance. o Scheduling and attending monitor visits. Advertise, recruit, and screen potential participants for the study. Clinical Conduct Perform all study activities following Good Clinical Practices (GCP). Manage multiple clinical trials simultaneously. Protect the safety of human subjects. Monitor appropriate sources for specific clinical study or federal regulation updates. Collect and enter study data into the appropriate system. Coordinate and monitor screening activities; provides support as required. Assist with informed consent of study subjects. Submit data in required timeframe. Monitor appropriate sources for specific clinical study or federal regulation updates. Complete Case Report Forms. Facilitate audits of study data. Develop patient rapport to explain research protocols and minimize protocol violations. Develop rapport with study team to educate team on study procedures and minimize protocol violations. Respond to inquiries by auditors for data clarification or additional data in required timeframe. Take the lead and/or overall coordination of clinic activities including, but not limited to: o Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable. o Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required. o In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations. Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings. Post-Clinic/Close-Out Activities Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings. Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation. Review and update TMF documentation. Finalize study and/or volunteer logs. Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.). Responsible for monitoring subjects' compliance throughout the trial and address day-to-day. subject or study issues and escalate as appropriate. Prepare for and participates in sponsor/monitor/QA audits. Provide accurate and timely project status updates to Project Managers and sponsor. Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals. Accommodate flexible schedule (available days, afternoons, nights, and weekends). Perform other work-related duties as assigned. Coordinate and Perform Regulatory Activities Maintain proper protocol, consent, amendment, and yearly renewal submission if requested. Report adverse events relating to the trial. Maintain study files. Travel up to 100% QUALIFICATION REQUIREMENTS Registered Nurse and/ or University Degree such as Bachelor of Science Degree required. Clinical Research certification preferred. A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred. Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Required skills: problem solving, planning, and evaluation. Possess good time management, detail-oriented, and able to multi-task. Good interpersonal and communication skills with a team focus. Knowledge of SOP writing. Ability to anticipate problems and provide solutions in a timely manner. Ability to coordinate multiple clinical research projects with competing deadlines. Proficiency in computer software programs (e.g. Word, Excel, Power Point). Proficiency in use of various clinical trial EDC software preferred. Disclaimer: Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Additional Information: Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Discover Impactful Work: We are seeking a Clinical Research Coordinator III (Registered Nurse) to support our government customer on-site in Silver Spring, Maryland . This is a per diem, non benefited position. Availability needed (6:00 am - 10: 00 am). Relocation assistance is NOT provided for this role. Must be a U.S. citizen. Must be able to pass a comprehensive background check, which includes a drug screening and a physical. Required to be a Registered Nurse licensed to practice in the state of Maryland. A day in the Life: Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting. Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed. Organizes research information for clinical projects Selects and observes subjects and assists with data analysis and reporting. Oversees experiment scheduling and collection of data. Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc. Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. Maintains study/test article or investigational product accountability and administration. Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance. Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks. Keys to Success: Required Education Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. Basic Life Support (BLS -CPR/AED) certification. Required Experience and Skills: Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials. Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform). Must be able to work both independently and in a team setting following a brief period of specific technical training. Must have excellent communication, organization, and prioritization skills. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Maintenance of Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Desired Experience and Skills Advanced Cardiac Life Support (ACLS) certification encouraged. Certification in clinical research (e.g., CCRP or CCRA) is preferred. Commission for Case Manager Certification (CCMC) certification preferred. Compensation and Benefits The salary pay range estimated for this position CRA (Level II) based in Maryland is $38.46-$44.23. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

About SynapticureAs a patient and caregiver-founded company, Synapticure provides instant access to expert neurologists, cutting-edge treatments and trials, and wraparound care coordination and behavioral health support in all 50 states through a virtual care platform. Partnering with providers and health plans, including CMS' new GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases such as Alzheimer's, Parkinson's, and ALS.Synapticure conducts innovative, patient-centered research programs, including remote and decentralized clinical trials and Expanded Access Programs (EAPs), designed to bring investigational therapies to patients who need them most. The RoleThe Clinical Research Coordinator II (CRC II) plays a critical role in supporting Synapticure's remote and decentralized research portfolio, including an Expanded Access Program providing investigational treatment for individuals living with ALS. This role is ideal for an experienced research professional who can manage study activities independently while partnering closely with investigators, research leadership, and cross-functional clinical teams.As a CRC II, you will oversee day-to-day study execution, ensure regulatory and documentation compliance, and serve as a primary point of contact for research participants and caregivers. You will balance operational rigor with compassion, helping deliver a seamless, ethical, and patient-centered research experience in a fast-paced, mission-driven environment.Successful candidates are detail-oriented, proactive, and comfortable navigating complex research workflows while supporting patients and families affected by neurodegenerative disease. Job Duties - What you'll be doing Independently coordinate assigned study activities in compliance with protocols, SOPs, GCP, and regulatory requirements. Screen and evaluate potential research participants for eligibility, documenting inclusion/exclusion criteria and escalating complex questions as needed. Manage scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities. Collect, review, and enter study data accurately and in a timely manner using EDC systems and study tools. Maintain complete, accurate, and audit-ready study documentation, including regulatory binders, participant records, and tracking logs. Conduct or support informed consent discussions, ensuring proper documentation, version control, and regulatory compliance. Serve as a primary point of contact for research participants and caregivers, addressing routine questions and coordinating logistics. Prepare for and support sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving findings. Track and report study metrics such as enrollment, retention, deviations, and visit completion. Identify operational risks or inefficiencies and proactively communicate improvement opportunities to research leadership. Collaborate closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality research experience. Support onboarding and informal mentoring of junior research staff, as appropriate. Requirements - What we look for in you Bachelor's degree in a scientific, health-related, or behavioral field preferred. 2-3 years of experience as a Clinical Research Coordinator or equivalent role. Experience working with human subjects research required; neurology, ALS, or decentralized trial experience preferred. Working knowledge of GCP, informed consent requirements, and clinical research regulations. Ability to manage study responsibilities independently while knowing when to escalate issues. Strong organizational skills with the ability to prioritize across multiple studies and deadlines. Excellent written and verbal communication skills, including comfort working directly with patients and caregivers. Experience using EDC systems, CTMS, electronic health records, and study tracking tools. Comfort working in a fully remote research environment using virtual communication platforms. Collaborative, adaptable, dependable, and aligned with Synapticure's mission and values. We're founded by a patient and caregiver, and we're a remote-first company. This means our values are at the heart of everything we do, and while we're located all across the country, these principles are what tie us together around a common identity: Relentless focus on patients and caregivers. We are determined to provide an exceptional experience for every patient we have the privilege to serve, and we put our patients first in everything we do. Embody the spirit and humanity of those living with neurodegenerative disease. Inspired by our founders, families, and personal experiences, we recognize the seriousness of our patients' circumstances and meet that challenge every day with empathy, compassion, kindness, and hope. Seek to understand, and stay curious. We start by listening to one another, our partners, our patients, and their caregivers. We communicate with authenticity and humility, prioritizing honesty and directness while recognizing we always have something to learn. Embrace the opportunity. We are energized by the importance of our mission and bias toward action.

--------------------------------------------------------------- This position is responsible for assisting with the management of the pharmacy benefit and developing and delivering clinical and educational interventions designed to improve pharmaceutical use. Responsibilities include formulary management; assisting with management of specific patients in the multidisciplinary case management/medication therapy management program, P&T, developing and conducting educational initiatives to improve prescribing patterns; develop and conduct quality improvement programs related to the pharmacy program; evaluating medication authorization requests and providing oversight to the medication PA process; and other pharmacy program activities as assigned. NOTE: This is a temporary position expected to last 9 months. Estimated Hiring Range: $151,965.00 - $185,735.00 Bonus Target: Bonus - SIP Target, 5% Annual Current CareOregon Employees: Please use the internal Workday site to submit an application for this job. --------------------------------------------------------------- Essential Responsibilities Prepare drug utilization reports and analyses for the Pharmacy & Therapeutics Committee. Use an evidence-based process to perform new drug reviews, and to develop formulary recommendations and drug use criteria for the Pharmacy & Therapeutics Committee. Critically evaluate drug therapy regimens for patients enrolled in the case management program and assist with developing treatment plans. Provide medication therapy management services. Develop and conduct retrospective drug use reviews. Review medication prior authorization requests and appeals. Develop and implement clinical educational programs to improve drug utilization and quality. Review and refine policies and procedures regarding Pharmacy Department functions including medication therapy management, DUR programs, medication prior authorization, and others. Develop and conduct quality improvement programs related to the pharmacy program. Monitor functions provided by the plans' Pharmacy Benefit Manager including pharmacy benefit coding, customer service guidelines, prior authorization activities, and other delegated services. Develop and critically evaluate pharmacy claim data analysis/reports in support of specific projects or program objectives. Assess, review, and respond to federal and state regulatory requirements/audits of the pharmacy benefit. Consult with clinicians and pharmacists to resolve pharmacy benefit issues. Review and refine pharmaceutical reimbursement and purchasing procedures. Develop materials to communicate pharmacy benefit or other information to members, clinicians, and pharmacists. Experience and/or Education Required Graduate of an accredited pharmacy program Current, unrestricted license as a pharmacist in Oregon Advanced pharmacy training (PharmD, residency, fellowship, or master's degree in related discipline) Practical experience as a clinical pharmacist in formulary management or ambulatory care or other clinical setting Preferred Previous experience in managed care Experience with reviewing Prior Authorization requests against plan criteria and making approval or decline decisions Knowledge, Skills and Abilities Required Knowledge Must have comprehensive, clinical pharmaceutical knowledge base Knowledge of the principles of managed care, pharmacy benefit management, pharmaceutical reimbursement, and pharmaceutical utilization Skills and Abilities Ability to critically evaluate clinical pharmaceutical and medical literature and apply principles of evidence-based medicine Ability to design and review pharmacy claims analysis/reports according to specific project requirements Must be highly motivated and have the ability to work independently Excellent organizational, project management, and time-management skills Excellent written and verbal communication skills Excellent customer service skills Ability to manage multiple tasks Ability to negotiate, problem-solve, and consensus-build Basic word processing, spreadsheet, and database skills Ability to work effectively with diverse individuals and groups Ability to learn, focus, understand, and evaluate information and determine appropriate actions Ability to accept direction and feedback, as well as tolerate and manage stress Ability to see, read, hear, speak clearly, and perform repetitive finger and wrist movement for at least 6 hours/day Ability to lift and carry for at least 1-3 hours/day Working Conditions Work Environment(s): ☒ Indoor/Office ☐ Community ☐ Facilities/Security ☐ Outdoor Exposure Member/Patient Facing: ☒ No ☐ Telephonic ☐ In Person Hazards: May include, but not limited to, physical and ergonomic hazards. Equipment: General office equipment Travel: May include occasional required or optional travel outside of the workplace; the employee's personal vehicle, local transit or other means of transportation may be used. Work Location: Work from home We offer a strong Total Rewards Program. This includes competitive pay, bonus opportunity, and a comprehensive benefits package. Eligibility for bonuses and benefits is dependent on factors such as the position type and the number of scheduled weekly hours. Benefits-eligible employees qualify for benefits beginning on the first of the month on or after their start date. CareOregon offers medical, dental, vision, life, AD&D, and disability insurance, as well as health savings account, flexible spending account(s), lifestyle spending account, employee assistance program, wellness program, discounts, and multiple supplemental benefits (e.g., voluntary life, critical illness, accident, hospital indemnity, identity theft protection, pre-tax parking, pet insurance, 529 College Savings, etc.). We also offer a strong retirement plan with employer contributions. Benefits-eligible employees accrue PTO and Paid State Sick Time based on hours worked/scheduled hours and the primary work state. Employees may also receive paid holidays, volunteer time, jury duty, bereavement leave, and more, depending on eligibility. Non-benefits eligible employees can enjoy 401(k) contributions, Paid State Sick Time, wellness and employee assistance program benefits, and other perks. Please contact your recruiter for more information. We are an equal opportunity employer CareOregon is an equal opportunity employer. The organization selects the best individual for the job based upon job related qualifications, regardless of race, color, religion, sexual orientation, national origin, gender, gender identity, gender expression, genetic information, age, veteran status, ancestry, marital status or disability. The organization will make a reasonable accommodation to known physical or mental limitations of a qualified applicant or employee with a disability unless the accommodation will impose an undue hardship on the operation of our organization.

The purpose of this position is to assist the College in fulfilling its mission by facilitating student acquisition of the required knowledge, attitudes, and skills necessary for success in the student's chosen career in health sciences. ESSENTIAL FUNCTIONS: * Provides teaching, supervision and evaluation of student learning experiences in didactic, lab, and/or clinical environments. * Correlates clinical education with didactic education. * Provides individual advisement and guidance for intellectual and professional development of students. * Coordinates clinical education and evaluates effectiveness. Provides recommendations for improvement to Program Chair. * Ensures student outcomes are met by participating and assisting with assessment activities. * Serves as an academic advisor for students. * Collaborates with other faculty, preceptors, field faculty, and clinical agencies to provide optimum learning opportunities for students. * Develops, implements and revises course content in a limited subject area. * Serves as a mentor to new or inexperienced faculty as appropriate. * Participates in scholarly activities (e.g., grant writing, research, college projects, publications, creative teaching strategies). * Participates in and seeks out quality improvement opportunities. * Holds office hours for students. * Performs miscellaneous duties as assigned. MINIMUM KNOWLEDGE/SKILLS AND ABILITIES REQUIRED: * Bachelor's degree in Radiology Technology or related field. * Two years' clinical experience in radiology technology. * Current and valid certification in American Registry of Radiology Technology. * Current Ohio General Permit to Practice. * Current and valid certification in Cardio-pulmonary Resuscitation. * Demonstrated experience providing guidance or training to others. * Minimum one year experience as an instructor or as a preceptor in a JRCERT accredited program. * Proficient in curriculum design and/or course development, instruction, evaluation and academic counseling * Master's degree preferred. Our Commitment Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. ** Summary:** The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. **Responsibilities And Duties:** Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Minimum Qualifications:** Bachelor's Degree (Required) **Additional Job Description:** required from a four year college or university **SPECIALIZED KNOWLEDGE** Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) **DESIRED ATTRIBUTES** One year of relevant work or academic experience preferred Prior experience in a medical environment preferred Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification) One or more years of direct human subjects research Clinical knowledge in assigned therapeutic area or program **MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS** **Study Planning and Coordination** Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carryout the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations. Assist with recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participate in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. After closeout visits have been conducted, prepares study documents for archiving according to timelines. Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. **Patient Care** Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe and report adverse events and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. **Quality and Compliance** Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. **Reporting** Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. **Communication** Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Work with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. **Other** Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Work Shift:** Day **Scheduled Weekly Hours :** 40 **Department** Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

Job Title: MSW Student Intern - Psychotherapy and Group Facilitation Practice Setting:Mid-sized Group Private Practice In-Person Internship Duration:Duration is determined by the course requirements for your MSW program. These requirements vary by university, program, and academic standing. About Us: We are a dynamic mid-sized group private practice located in Gahanna, Ohio, committed to providing quality mental health services to our community. As part of our commitment to social responsibility, we offer pro bono programming for military sexual trauma survivors, providing specialized support to those in need. Internship Overview: We are seeking a motivated MSW student intern to join our team and contribute to our mission of supporting individuals affected by military sexual trauma (MST). The internship will focus on providing psychotherapy to clients in our new MST pro bono program, clients who experience a variety of mental health symptoms, as well as observing and facilitating group therapy and peer support groups. The intern will work closely with the clinical director to build a strong foundation of clinical skills in a supportive and collaborative environment. Key Responsibilities: 1.Psychotherapy:Provide individual psychotherapy to clients enrolled in our pro bono programming for military sexual trauma, providing psychotherapy for clients with various mental health concerns, utilizing evidence-based therapeutic approaches. Observation of psychotherapy with children, teens, adults, couples, families and groups. 2.Group Therapy and Peer Support:Observe and facilitate group therapy and peer support groups under the guidance of the clinical director. Contribute to the development and implementation of group programming. 3.Collaboration:Work closely with the clinical director and other team members to ensure cohesive and client-centered care. Participate in case consultations and team meetings. 4.Clinical Skill Development:Engage in ongoing training and supervision to enhance clinical skills. Receive constructive feedback to support professional growth. 5.Compliance:Adhere to ethical guidelines and standards, including maintaining client confidentiality. Ensure compliance with all academic requirements outlined by the university. Qualifications: 1. Currently enrolled in an MSW degree program. 2. Ability to pass a background check. 3. Obtain a Social Work Trainee (SWT) license. 4. Commitment to completing all academic requirements outlined by the university. Skills and Attributes: 1. Empathy and sensitivity to the needs of trauma survivors and those with various mental health concerns. 2. Strong interpersonal and communication skills. 3. Ability to work collaboratively in a team-oriented environment. 4. Eagerness to learn and apply evidence-based therapeutic approaches. Benefits: 1. Supervision and mentorship from experienced licensed professionals. 2. Exposure to diverse clinical experiences in a group private practice setting. 3. Opportunities for professional development and training. 4. Contribution to a meaningful and socially responsible mission. Application Process: To apply, please submit your resume, a cover letter outlining your interest and relevant experience, and contact information for two professional references. Interviews will be scheduled for qualified candidates. This internship will need to be approved by your university's field education program if we are not already an approved organization. Deadline for Application:We are seeking interns who are prepared to start in the spring 2024 semester. Join us in making a positive impact on the lives of military sexual trauma survivors. This internship offers a unique opportunity to gain valuable clinical experience while contributing to a cause that matters. We look forward to welcoming a dedicated and passionate MSW student intern to our team. Job Type: Contract Salary: $12.00 - $18.00 per hour Benefits: Continuing education credits Flexible schedule Professional development assistance Tuition reimbursement Healthcare setting: Clinic Outpatient Medical specialties: Addiction Medicine Psychiatry Patient demographics: Adolescents Adults Children Older adults Schedule: Choose your own hours Day shift Evening shift Work Location: In person

Who We Are Vial is a hyper-scalable biotech company advancing programs into the clinic by leveraging dramatically cheaper trials and computationally designed therapeutics. Our mission is to reimagine drug development in order to cure all human diseases. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision. Vial is fully remote and was founded by Simon Burns in October 2020. Since our founding, we have grown rapidly to a team of 50+ employees with over $100 million in funding from leading investors including General Catalyst, Box Group, and Byers Capital. Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery. Why You'll Love Working At Vial Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life. Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact. The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together. Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn. What You'll Do Support the Clinical Development team in planning and execution of early-stage clinical trials. You'll gain exposure to protocol development, trial operations, and the systems that keep studies running smoothly. Key Responsibilities * Assist with preparation and review of trial documents (protocols, informed consent forms, study reports) * Track study timelines, milestones, and deliverables * Help organize and maintain clinical trial data, regulatory submissions, and correspondence * Support coordination with sites, CROs, and internal stakeholders * Contribute to process improvement projects within clinical operations What You Will Bring * Strong organizational skills and attention to detail * Interest in clinical research, drug development, or healthcare operations * Ability to manage multiple tasks and prioritize effectively * Strong written and verbal communication skills Preferred Skills * Background in life sciences, public health, or related field * Familiarity with clinical trial design or regulatory environment (FDA, ICH/GCP) * Experience with project management tools (Notion, Excel, or similar) * Previous internship or coursework in clinical research a plus

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Career Programs Job Sub Function: Non-LDP Intern/Co-Op Job Category: Career Program All Job Posting Locations: Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Johnson & Johnson Innovative Medicine is recruiting for multiple Clinical Pharmacology and Pharmacometrics summer interns at its US (Spring House PA, Raritan NJ, Titusville NJ, Cambridge MA and La Jolla CA) sites. Clinical Pharmacology and Pharmacometrics (CPP) is an integrated part of the Global Development organization within Johnson & Johnson Innovative Medicine. Members of CPP work in cross-disciplinary compound development teams and apply Clinical Pharmacology principles and pharmacometrics methodologies across the R&D portfolio to enable optimal decision-making in drug development. The CPP Summer Internship Program provides a unique opportunity for students passionate about drug development to collaborate with clinical pharmacologists and pharmacometricians and gain hands-on experience in CPP principles, including pharmacokinetics/pharmacodynamics (PK/PD), translational modeling, and model-informed drug development (MIDD) within a dynamic pharmaceutical R&D environment. Our teams leverage students' academic backgrounds while fostering their professional development, providing firsthand experience in drug development and an opportunity to evaluate the student's potential for future employment. CPP summer interns will contribute to diverse Research and Development efforts spanning preclinical to early- and late-stage clinical development, through activities such as: Clinical Pharmacology and Medical literature review Data analysis of PK, biomarker, preclinical and/or clinical data, trial design, etc. PK and PD model-building and analyses Development of computer programs or state-of-the-art quantitative methodologies (e.g., population PK/PD, quantitative systems pharmacology [QSP]) Model based meta-analysis (MBMA), advanced data visualization (e.g., RShiny), and machine learning applications integrating publicly reported and in-house data Therapeutic areas of immunology, oncology, neuroscience, cardiopulmonary and metabolic diseases Qualifications Candidates must be enrolled in an accredited college or university (not necessarily taking classes) pursuing a MS, PharmD, PhD, MD or similar degree in a life sciences-related discipline such as Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Molecular or Computational biology, Biophysics, Biostatistics, Mathematics, Engineering, or Medicine. Candidates should demonstrate computational proficiency, including experience with data analysis, modeling, and simulation tools such as NONMEM, Phoenix WinNonlin, Monolix, R, Python, or MATLAB. Candidates must be available to work full-time for at least 12 weeks between May - September 2026. Candidates must be detail-oriented, highly organized, and capable of managing multiple tasks efficiently. Candidates must have strong communication and presentation skills. Candidates must have the ability to work independently as well as collaboratively within a team. Candidates must be eligible to work in the US for the entirety of their internship period and will be required to provide proof of work authorization. Remote work flexibility may be available. Housing stipend will be available. Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $23.00/hr to $51.50/hr Additional Description for Pay Transparency: The expected pay range for this position is between $23.00 per hour and $51.50 per hour but will be based on candidate's program year, discipline, degree and/or experience. Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company's consolidated retirement plan (pension). For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 09/11/2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.