Clinical research associate work from home jobs - 183 jobs

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

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

At Praxis, we turn neuroscience discoveries into treatments that improve patients' lives. The Clinical Research Associate (CRA) plays a key role in monitoring clinical trials and ensuring they are conducted to the highest quality and compliance standards. This position involves direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support the successful execution of studies. Key Responsibilities Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and regulatory requirements. Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases. Review monitoring reports and follow-up letters to ensure timely resolution of issues. Assist CTMs in site activation activities and provide ongoing site management support. Collaborate with cross-functional teams (Data Management, Medical, Regulatory, Quality) to maintain high-quality trial conduct. Identify and escalate protocol deviations, data integrity issues, and safety concerns. Maintain study files and documentation, ensuring compliance with SOPs and trial master file (TMF) requirements. Support investigators and site staff with training and guidance on study procedures. Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus). 3+ years of clinical research experience, including site monitoring responsibilities. Strong knowledge of ICH-GCP, FDA regulations, and international trial standards. Excellent organizational, communication, and problem-solving skills. Ability to manage multiple priorities and work independently as well as in a team. Willingness to travel as needed for monitoring visits (up to 50-75%). Preferred Experience Previous experience in CNS or rare disease clinical trials. Strong understanding of GCP, FDA, and global trial regulations. Familiarity with registrational trial requirements. Praxis Values Patients First Scientific Rigor Integrity Collaboration Urgency with Purpose Accountability The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary$103,000-$122,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Piper Companies is seeking a well-rounded Clinical Research Associate with direct oncology monitoring experience to work with a Global CRO. The Clinical Research Associate will be working remote with some travel included. Requirements for the Clinical Research Associate include: * Conducting site monitoring visits in line with GCP and ICH guidelines * Ensure project needs are met by collaborating with local sites * Oversee regulatory submissions, CRF completion, and data query resolutions * Ensure documentation is properly formatted and filed; TMF and ISF * Mentor clinical staff during visits Qualifications for the Clinical Research Associate include: * 2+ years of Oncology monitoring experience * 2+ years of onsite monitoring experience * Able to travel locally for work * Proficient in GCP and ICH guidelines * Understand Microsoft Office and mobiles devices * Strong understanding of Phase 1 oncology trials (phase 2 and 3 are welcomed) * Bachelor's degree in a related field Compensation for the Clinical Research Associate includes: * Salary range: $90,000 - $120,000 * Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays Keywords: Clinical research associate, CRA, hospital, travel, oncology, documentation, trials, trial sites, cancer, cancer research, GCP, ICH, recruitment plans, projects, project, protocol adherence, regulatory submissions, enrollment, CRF completion, data, data query, start-up phase, phase 1, trial master file, TMF, Investigators site file, ISF, mentorship, Microsoft office, mobile devices #LI-BH1 #LI-REMOTE This job opens for applications on 1/9/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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

Join our CRA Team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! MEDPACE CRA TRAINING PROGRAM (PACE ) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: * PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. * PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. * To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). 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 life science related field; * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. 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. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs 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.

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

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

Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience Remote Clinical Research Associate III requires: Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm EST Qualifications: BS/BA Minimum of 2 years of site management and field monitoring experience Knowledge of applicable standards and regulations for clinical trials Proven oral and written communication skills Proven planning skills; ability to create and track detailed project plans Proven interpersonal, leadership, organizational and effective time management skills Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion Preferred: Experience in womens fertility VD Study Experience Medidata RAVE system Remote Clinical Research Associate III duties: Performs Site initiation, interim & close out monitoring visits Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete Manages site communication and escalates to leadership in a timely fashion when needed Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

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

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Working closely with the Sr. Clinical Trial Manager and Clinical Operations Team, the Clinical Trial Associate (CTA) contract position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs). The CTA will support the Sr. Director of Clinical Operations and Clinical Trial Managers (CTM) in day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment. This incredible opportunity will put the right candidate at the forefront of medicine, working on ground breaking trials with tremendous potential to impact patient's lives. You will join a team of incredibly dedicated professionals whose talent is matched by their commitment and passion for the work we are doing. A team that remains focused on what's important for the patient and also has an incredible track record of growth and development among them. If you are looking to learn, work hard, and make a difference, we would like to speak with you. Responsibilities Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out Coordinate study documents and training tools for coordination with clinical sites Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders Coordinate study meetings, materials and agendas; record and disseminate decisions and actions Responsible for internal meeting agendas/minutes as applicable Responsible for updating, maintaining and quality control of the eTMF and other document repositories Responsible for study laboratory sample tracking and vendor management support Track new vendors and purchase orders in financial system Coordinate version control of clinical documents, prioritize multiple tasks and/or projects Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages Support Clinical Operations team with specific projects Effectively communicate with study team members and work closely to address challenges Minimum Qualifications BS/BA degree or equivalent and at least 1-3 years experience in clinical operations in Sponsor company Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations Experience with eTMF; ability to directly apply essential document knowledge to file documents Effective communication, organizational and interpersonal/team skills Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred. Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines Participate in inter-departmental workgroups to create or enhance processes Strong attention to quality/detail Good organizational and time management skills Willingness to work in a flexible environment Preferred Qualifications Additional Years of clinical operations experience inside a Sponsor company Experience with global studies, using an outsourced CRO model Experience in clinical drug development with knowledge of First in Human trials Experience with regulatory affairs, including IND/CTA submissions Knowledge of transplant, oncology or cellular therapies Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $40.00 - $50.00 per hour. The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Department: MED-Impact Institute Salary/Grade: NEX/11 Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Job Activities: Primary activities involve the scheduling and retention of research participants in the RADAR study with young people ages 16-29. Specific activities include: following established protocols for contacting and scheduling participants; tracking participants for retention purposes; conducting study assessments; maintaining accurate, timely and detailed records of participant contact; maintaining and updating databases; and other project-related responsibilities. The Research Study Coordinator is expected to work in-person at study sites without a regular work from home schedule. The position will also require some evening hours (e.g., 11 AM - 7 PM) and weekend shifts to maximize retention efforts for study participants who are unavailable during the regular workday. We are seeking a diverse pool of candidates. Candidates from backgrounds traditionally underrepresented in research are encouraged to apply. Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters. Work Location Requirement As this role supports an in-person research study, full-time on-site presence is required. Direct coordination with participants, staff, and study resources must occur on campus to ensure the integrity of study operations and participant engagement. Remote, hybrid, or work-from-home arrangements are not possible for this position. Driver's License Requirement Because this position involves the use of a mobile unit to conduct research study visits, applicants must hold a valid driver's license and meet the eligibility criteria of the University's Safe Driver Program. This includes following all program guidelines regarding responsibilities, safe driving practices, and authorization for vehicle use on University business. Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Obtains informed consent * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. * Completes basic clinical procedures such as drawing blood & obtaining blood pressure. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process payments for research participants per study protocol. * Works with industry representatives to negotiate tentative grant funding. * Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Minimum Qualifications: * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Minimum Competencies: (Skills, knowledge, and abilities.) * Strong project coordination skills and the ability to prioritize tasks. * Supervisory experience. * Effective time management skills. * Efficient and resourceful in problem-solving. * Demonstrated attention to detail and ability to adhere to instructions/procedures. * Good communication skills; demonstrated effective spoken and written communication. * Demonstrated ability to take ownership of the work, possessing initiative, and good follow-through. * Knowledge of basic computer skills, familiarity with Windows environment. Preferred Qualifications: * Experience working with LGBT youth. * Experience working in public health, psychology, and/or medical research. * Experience working in non-profit, community-based settings. * Experience recruiting and tracking study participants or experience with youth development and community outreach. * Phlebotomy certification and experience Preferred Competencies: (Skills, knowledge, and abilities) * Knowledge of HIV and HIV risk among YMSM. * Ability to work in a team environment. * Ability to work with minimum supervision and guidance. * Ability to receive and benefit from feedback; willingness to expand skill set and improve. * Flexibility in adapting to new procedures and environments. Target hiring range for this position will be between $19.89 -$24.04 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

Study Participants About Prolific Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes A Difference The Travel Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. This role will perform a variety of clinical and administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. Much of the work for this role will be done onsite at a clinical event or site location. How You'll Make An Impact Perform independent venipuncture; manage difficult draws and re-attempts per protocol. Collect, label, process, package, and ship biospecimens; maintain chain of custody and temperature controls. Set up/tear down event sites; prepare kits/supplies; uphold aseptic technique and biohazard safety. Communicate clearly with participants and on-site teams; escalate issues promptly. Ability to understand and follow institutional SOPs. Participate in recruitment and pre-screening events (may be multiple locations). Assist with preparation of outreach materials. Request medical records of potential and current research participants. Schedule visits with participants, contact with reminders. Obtain informed consent per Care Access Research SOP, under the direction of the Clinical Research Coordinator (CRC). Complete visit procedures as required by protocol, under the direction of the CRC. Record data legibly and enter in real time on paper or e-source documents. Request and issue study participant payments. Update all applicable internal trackers and online recruitment systems. Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs. Assist with inventory and ordering equipment and supplies. Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other Care Access Research personnel. Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision. Ability to learn to work in a fast-paced environment. Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. Contribute to team and site goals. Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, “can do” attitude. Certifications/Licenses, Education, and Experience: 1+ year recent hands-on phlebotomy experience in a clinical setting. ≥200 total venipunctures; ≥25-50 capillary sticks; ≥30-50 sticks in the last 2-3 months. Some Clinical Research experience preferred. Demonstrated competency in specimen processing. Working knowledge of ICH-GCP, basic research terminology, and HIPAA/PHI handling. Comfortable using mobile apps/eSource and standard office tools. Current national phlebotomy certification (one of): ASCP Phlebotomy Technician (PBT) AMT Registered Phlebotomy Technician (RPT) NHA Certified Phlebotomy Technician (CPT) NCCT National Certified Phlebotomy Technician (NCPT) CA/WA/LA/NV specific licensure/certification if role is based there How We Work Together Location: Candidates must be willing to travel in support of community events within your metropolitan area and occasional national travel. Travel: Duties may require travel in the following models: Tuesday through Saturday Work Weeks Temporary Event Support (3-7-day deployment durations) Frequency and length of travel may depend on the length and location of study, site, and event. Deployments normalize to a 32 to 42-hour work week on average. The expected salary range for this role is $24.00 - $38.00 USD per hour for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************