Clinical associate work from home jobs - 132 jobs

We are seeking a dedicated Clinical Research Coordinator to join our prestigious research team. You will play a pivotal role in screening, consenting, and enrolling patients in oncology trials, as well as managing their journey through the course of therapy. This patient-facing role involves extensive collaboration with clinical staff to ensure protocol compliance and the successful execution of research procedures. Responsibilities + Screen, consent, and enroll patients on oncology trials, ensuring protocol compliance. + Document patient interactions and procedures in the Electronic Medical Records (EMR) system. + Order labs and manage source documentation for patient trials. + Collaborate with clinic staff to schedule patient appointments, such as EKGs and vitals. + Interact with nursing staff and medical assistants to ensure seamless patient care. + Work with infusion nurses to coordinate appointment schedules. + Assist with pre-screening patients, chart reviews, and patient recruitment. + Provide patients with a personalized calendar of events and study checklists. + Identify and manage potential side effects in oncology patients. Essential Skills + Minimum of 2 years of experience as a Clinical Research Coordinator (CRC). + Proficiency in clinical research, pre-screening patients, and patient recruitment. + Strong organizational skills and ability to read and interpret clinical protocols. + Bachelor's degree in a related field. Additional Skills & Qualifications + Experience with patient study enrollment and managing study requirements. + Ability to assist patients with trial participation aspects. + Knowledge of oncology patient care and support during therapy. Work Environment Join one of the 41 comprehensive cancer centers, renowned for cutting-edge research and novel treatments. Work with dedicated investigators in a collaborative and supportive environment. Trials include pharmaceutical sponsor-led studies and investigator-led projects, with a mix of federal, institutional, and industry sponsorships. Disease teams are determined by candidate experience and business needs. Work schedule is Monday to Friday, 8 AM to 5 PM, with some flexibility. The role requires on-site presence for clinic visits, providing an opportunity to work closely with clinical and data management teams. Job Type & Location This is a Contract to Hire position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $30.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jan 30, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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 II/ Sr. 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. Salary range: $110,520.00-$138,150.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast. Travel Expectation: Travel (by automobile or air, day trips and overnight stays) up to 30% of the time. Position Summary: The Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies. This role will be responsible for study site management, including site qualification, training, activation, and monitoring. Key Responsibilities: * Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations * Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits * Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed * Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans * Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns * Ensures quality and completeness of central and site master files * Oversees site investigational product requirements and device accountability * Supports the planning and coordination of Investigator Meetings * Other duties as assigned Qualifications and Skills: * 2+ years clinical research study monitoring for medical device or related experience * BS degree in relevant area of study * Knowledge of federal and local regulations and policies pertinent to research involving human subjects * Knowledge of ICH, GCP and Declaration of Helsinki * Excellent communication, interpersonal and organizational skills * Ability to collaborate in a team environment and work independently * Self-starter with the ability to manage projects and effectively prioritize tasks in a dynamic, start-up environment * Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Remote

As an innovative research institute, Alcedis provides clinical research services supported by a modern information technology infrastructure. Our flat hierarchies and collaborative culture foster a flexible, dynamic, and team-oriented working environment. We are seeking a Clinical Research Associate / Clinical Monitor / Site Manager (home-based) to join our Clinical Operations team. In this role, you will play a key part in site monitoring activities and in ensuring protocol compliance and overall study quality at investigational sites. You will independently monitor U.S. study sites and may also support Canadian sites as needed, working in close and regular contact with the responsible Project Manager or Lead Clinical Research Associate at Alcedis in Germany or the United States. We are looking for candidates based in the Eastern United States, ideally in or near major metropolitan areas such as Boston, New York City, Philadelphia, Pittsburgh, Columbus, Detroit, Atlanta, or Raleigh-Durham. Candidates located in other parts of the Eastern U.S. will also be considered. Provide on-site and remote support in the organization and conduct of the study and supervision of the investigators Prepare, conduct and follow-up of site initiation, monitoring and close-out visits (remote or on-site) Assess study progress at assigned sites according to predefined guidelines and ensure complete, accurate documentation Validate study data collected by investigators (source data verification) Prepare monitoring visit reports and related documentation Evaluate study sites for compliance with applicable regulations, guidelines, and study protocols Collaborate closely with data manager and project manager Generate, track, and resolve queries Train investigators and study coordinators in the use of EDC systems Conduct feasibility assessments for new study sites and upcoming projects Support and coordinate study sites, including assistance with documentation and escalation of site-level issues Prepare documents for submission to regulatory authorities and ethics committees From day one, we expect you to bring: Bachelor's degree in natural or life sciences or a comparable qualification (e.g., Study Nurse certification) At least 3 years of hands-on monitoring experience in GCP-regulated interventional clinical trials Working knowledge of data privacy and protection regulations relevant to clinical trials, including HIPAA (U.S.) and FDA 21 CFR Part 11, familiarity with GDPR (EU) is a plus Ability to work independently, plan proactively, and execute tasks with foresight and attention to detail Strong communication and organizational skills Collaborative, team-oriented mindset Excellent written and spoken English Willingness to travel and flexibility to support study needs Annual salary: $75,000 - $95,000 DOE 15 days of paid vacation per year 6 paid sick days per year Health, dental and vision insurance for you and your dependents Employee life insurance Health Savings Account (HSA) 401(K) You'll work in a future-oriented and secure working environment A forward-looking, growth-oriented work environment Exciting and challenging projects that make an impact Flat organizational structure with an open and collaborative culture A dedicated, successful, and supportive team environment Varied work with the autonomy to take ownership of your projects Flexible working hours to support work-life balance We welcome applicants of all backgrounds and do not discriminate based on race, ethnicity, gender, sexual orientation, disability, age, religion, or any other protected characteristic. Come join us! Take the next step and apply today - we can't wait to meet you! To apply, submit your resume, a short cover letter, and a Clinical Trial Experience Table detailing your study experience (type, phase, sites, role) directly through the link or alternatively via our careers page: Career | Alcedis For more information about our company, please visit our website at Alcedis | Digital Clinical Trials

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

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Coordinates investigator/ site feasibility and identification process, as well as study startup. Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. Manages Monitors in the query resolution process, including Central Monitoring observations. Coordinates safety information flow and protocol/process deviation reporting. Performs clinical supplies management with vendors on a country and regional level. Ensures study-specific and corporate tracking systems are updated in a timely manner. Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. Coordinates planning of supervised monitoring visits and conducts the visits. Manages the project team in site contracting and payments. Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. Ensures ongoing evaluation of data integrity and compliance at a country/regional level. Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. Oversees project team in CAPA development and implementation. Coordinates project team in process deviations review, management and reporting. Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. Delivers trainings and presentations at Investigator Meetings. Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. Ensures data integrity and compliance at a site level. Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. Conducts project-specific training of site Investigators. Supports preparation of draft regulatory and ethics committee submission packages. Qualifications Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. Minimum of 4 years' site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. Experience with all types of monitoring visits in Phase II and/or III. Strong experience in Oncology preferred. Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. Full working proficiency in English. Proficiency in MS Office applications. Ability to plan, multitask and work in a dynamic team environment. Excellent Communication, collaboration, and problem-solving skills. Ability to travel up to 50% (depending on project needs). Valid driver's license (if applicable). Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

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.

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

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.

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.

This position assists in managing clinical research studies of Intermountain Healthcare and is responsible for the efficient coordination of clinical studies by working closely with clinical investigators, physicians, department managers and others. Essential Functions Collect, process, maintain, and ship study samples, ensuring proper stewardship of lab kits and shippers. Safely operate laboratory equipment when applicable. Understand assigned protocols and effectively communicate project details to patients, caregivers, and principal investigators. Screen participants for eligibility, obtain patient consent, and develop recruitment strategies. Monitor participant progression and manage patient visits to ensure protocol compliance. Coordinate clinical patient information and assist physicians or residents with gathering clinical data. Comply with training on clinical research coordination, FDA Good Clinical Practices (GCP), and standard operating procedures. Safely operate laboratory equipment and maintain research records in compliance with policies and regulations. Perform other duties as assigned, such as data entry, expense tracking, patient chart reviews, and source document creation, with moderate supervision. Skills Organizational Skills Communication Skills Team Oriented Compassionate High Reading Comprehension Administrative Skills Self-starter Critical Thinking Skills Job Specific Schedule is Monday - Friday 8am -5pm. occasional need for early start or later evening. Potential for 1 day work remote (if there is work that can be done remote) Minimum Qualifications Experience in a role requiring the ability to demonstrate proficiency with Microsoft and database applications. Experience using laboratory protocol, systems, and documentation techniques. Demonstrated experience in a healthcare, academics or research related setting or research related setting working with patients. Preferred Qualifications Bachelor's Degree or higher from an accredited institution. Prior experience in a clinical research setting. Expertise or prior experience in the clinical area applicable to this research role (ie cardiology, pulmonary, oncology, women and newborn, etc. Previous experience running an Investigational drug study is preferred. Physical Requirements Ongoing need for employee to see, read and understand information, labels, assess patient needs, operate monitors, identify equipment and supplies. Frequent interactions with patient care providers, patients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, alarms, needs, and issues quickly and accurately. Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient care, accessing needed information, etc. Expected to bend, lift, and carry patient files, documents, equipment, and supplies. Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment. For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles. Location: Intermountain Health Intermountain Medical Center Work City: Murray Work State: Utah Scheduled Weekly Hours: 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $25.02 - $39.41 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here. Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.

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.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking an intern to support the Clinical Development team. The Clinical Development team is responsible for leading the development of clinical programs for one or more product candidates within a specific therapeutic area. This individual will be responsible for assisting members of the Clinical Development team with a variety of day-to-day tasks, and ongoing projects. The Clinical Development Intern will report directly to the Director, Senior Clinical Scientist and will work cross-functionally. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Review study start-up process (i.e., scales, training, placebo mitigation, analysis, enhance patient engagement and dropout prevention, reduce data variability etc.) Review Clinical Data for ongoing/closing studies, and review draft study protocols for consistency Develop a comprehensive grid of key measures and outcomes from past and current therapeutic studies, both within our company and across the industry, to inform and optimize future study designs Assist in the development of department SOPs (e.g., SAP & Analysis and Reporting Plan) and guidelines (e.g., Diversity in Clinical Trials) Additional responsibilities as assigned Requirements / Qualifications Actively enrolled with a minimum 3.0 GPA in a graduate program with a focus on psychology (i.e., clinical psychology, experimental psychology, cognitive neuroscience, etc.) or a focus on a medical field (i.e., psychiatry, neuroscience, biology, pharmacy) A proactive, creative, and entrepreneurial approach to work Interest and/or experience in CNS diseases Excellent oral and written communication skills Demonstrates strong attention to detail Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) Organizational and critical thinking skills Strong interpersonal skills and the ability to work well in a team environment Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience and Knowledge Prior research experience preferred, but not required Basic knowledge of, or previous experience with Good Clinical Practice (GCP) Understanding of medical concepts, especially related to both Neurology and Psychiatry Interest in Pharmaceutical/Life Sciences industry a plus Accomplished background demonstrating teamwork, creativity, leadership, good judgement, and delivering results Additional Details The anticipated hourly rate for this role is $18-$25/hour. The salary offer will be based on a variety of factors, including experience, qualifications, and internal equity. This is a full-time and temporary role beginning in June and concluding in August. Final dates will be confirmed this spring. Successful candidates will be compensated at an hourly rate for the duration of the internship. Interns will work a maximum of 40 hours a week. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.