Clinical research assistant jobs near me - 164 jobs

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

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.

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

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

US Central, Clinical Research Associate, Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 2 years of experience as a Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

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

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: ********************************

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.

**Graduate School of Education, Stanford, California, United States** Research Post Date Jan 07, 2026 Requisition # 107987 TheStanford Center on Early Childhood, an initiative of the Stanford Accelerator for Learning, seeks a full time Research Coordinator to join our team. The Research Coordinator will support online survey administration, data processing and cleaning, and overall study administration activities on a fast-paced schedule. Note: This position is a 1-year fixed term appointment that may be renewed based on performance and funding. This position is eligible for a remote work agreement and limited travel may be required for convenings and events. Interested applicants should submit a resume and a cover letter describing why they are interested in this position at this stage of their career. Candidates must be eligible to work in the US. Visa sponsorship is not available for this position. **ABOUT US** Housed at Stanford Graduate School of Education, the Stanford Accelerator for Learningis the first university-wide initiative connecting scholars across disciplines and with external partners to bridge research, innovation, practice, and policy, and bring quality scalable and equitable learning experiences to all learners, throughout the lifespan. The Stanford Accelerator for Learning focuses on learning challenges most in need of new discoveries, evidence, and solutions and where we believe Stanford can make the most difference. Those include: adult & workforce learning, digital learning, early childhood education and development, equity in learning, learning differences, and policy & systems change. The Stanford Center on Early Childhood (SCEC) is an initiative of the Stanford Accelerator for Learning. The SCEC leverages the current moment of revolutionary science and fosters deep omnidirectional collaboration across sectors, seeking to change the way that research in early childhood is conducted, communicated, and utilized, with the overarching goal that each and every child thrives from the start. **POSITION SUMMARY** RAPID began as a program of two national surveys of households with children under age 6 and the child care workforce. Led by Philip Fisher, Stanford Center on Early Childhood Director, the RAPID National Survey administers monthly surveys on a rapid-cycle schedule, and has collected data from more than 25,000 households and 13,000 child care providers in all 50 states. The survey and data inform policy, advocacy, academic, parent and practitioner audiences on the experiences, challenges, and strengths of parents of young children and child care providers. The goal is to support parent- and provider-driven policies and programs that equitably and effectively serve families, providers, and young children. RAPID is now implemented in community, state, and national contexts, working in partnership with local and state organizations. The RAPID datasets are extensive and quickly growing, and include both quantitative and qualitative data. This position will include online survey administration, data processing and cleaning, and overall study administration activities on a fast-paced schedule. All members of the study team will play an integral role in providing timely and important data on the experiences of families with young children. This Research Coordinator will work collaboratively with RAPID's Project Leads and research team to incorporate new measures into the online survey instruments, administer the monthly surveys and collect data, and prepare those data for analysis. The Research Coordinator will maintain standardized documentation and follow all data cleaning and data management processes as outlined in the team's Manual of Procedures. The Research Coordinator may also be responsible for survey operation logistics, including managing participant payments, recruitment, and communications. Strong organizational skills, ability to handle multiple priorities, and excellent orientation to details are vital to success in this position. The Research Coordinator must be willing to work closely and collaboratively with other team members. The Research Coordinator must have experience working in fast-paced academic research settings and be able to communicate clearly with team members and other stakeholders about the work they are responsible for carrying out. This position does not have any direct supervision responsibilities. **Your primary responsibilities will include:** + Plan and perform research tasks requiring initiative and judgment by applying basic knowledge and understanding of scientific theory when precedents do not provide specific guidance. General instruction provided by the supervisor as needed. May interpret study results in collaboration with supervisor or PI. + Participate in the development and administration of survey instruments and rating scales requiring judgment in applying non-routine procedures. Analyze and summarize results for review with supervisor. Audit the accuracy and validity of data. + Review and audit case report forms for completion and accuracy with source documents, and ensure compliance with research protocols. + Identify, select, extract and summarize data and structured information. Present summary of findings to supervisor. + Conduct literature searches, and write literature summaries and manuscripts, requiring preliminary judgments after the supervisor outlines conceptual approach. + Build and organize data as requested by principal investigator or supervisor; use common statistical programs requiring the application of job control language in generating and organizing data. + Adapt new, nonstandard methods outlined by supervisor in designing and evaluating phases of research projects, (i.e., educational materials, questionnaires, strategies for recruitment, data quality control procedures and processes). May follow up with the Institutional Review Board (IRB) to ensure renewals are approved and completed, seeking guidance where necessary. + Assist with development, communication and design of research findings to internal and external audiences, which may include web updates, social media, and/or white papers, for use in recruitment, educational, or awareness of programs, with guidance from supervisor. + May orient and train new staff or students. **To be successful in this position, you will bring:** + Bachelor of Arts degree in an applicable social science related field, or combination of education and relevant experience in an applicable social science. + General understanding of scientific theory and methods, typically gained through completion of an undergraduate degree in a related field. + General computer skills and ability to quickly learn and master computer programs. + Ability to work under deadlines with general guidance. + Excellent organizational skills and demonstrated ability to complete detailed work accurately. + Effective oral and written communication skills. + Ability to work with human study participants. **Preferred Education & Experience:** + Familiarity with Qualtrics or other online survey tools + Experience using SPSS, R and/or other data management and analysis software + Demonstrated ability to use collaborative tools such as Google Drive, Dropbox, Slack, MS Teams, in an academic and/or professional context + Spanish/English language bilingual fluency **Physical Requirements*:** + Frequently perform desk-based computer tasks, grasp lightly/fine manipulation, lift/carry/push/pull objects that weigh up to 10 pounds. + Occasionally stand/walk, sit, use a telephone, writing by hand, and sort/file paperwork or parts. + Rarely twist/bend/stoop/squat, kneel/crawl, rarely reach/work above shoulders, operate foot and/or hand controls. _* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job._ **Working Conditions:** + May be required to work non-standard, extended or weekend hours in support of research work. The expected pay range for this position is $26.34-$34.00 per hour. Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (************************************************************* detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. **Why Stanford is for You:** Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Ourcultureandunique perksempower you with: + **Freedom to grow.** We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. + **A caring culture.** We provide superb retirement plans, generous time-off, and family care resources. + **A healthier you.** Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. + **Discovery and fun.** Stroll through historic sculptures, trails, and museums. + **Enviable resources.** Enjoy free commuter programs, ridesharing incentives, discounts and more! **How to Apply:** We invite you to apply for this position by clicking on the "Apply for Job" button. To be considered, you must submit a cover letter and résumé along with your online application. + _Finalist must successfully complete a background check prior to working at Stanford University._ + _This is a fixed-term position with an end date of one year and is renewable based on performance and funding_ + _Candidates must be eligible to work in the US. Visa sponsorship is not available for this position._ _The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned._ _Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law._ Additional Information + **Schedule: Full-time** + **Job Code: 4234** + **Employee Status: Fixed-Term** + **Grade: E** + **Requisition ID: 107987** + **Work Arrangement : Remote Eligible**

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.

School of Nursing has an outstanding opportunity for a Respiratory Care Research Coordinator (Intermittent) (Respiratory Care Lead (NE H NI CNU) The Spirometry 360 research team provides methodological spirometry expertise to clinical and study teams, including virtual spirometry coaching, overreading and grading, and training to facilitate optimal spirometry implementation. The Spirometry 360 Respiratory Care Research Coordinator will assist with the development and implementation of research protocols while ensuring research projects are conducted in compliance with federal regulations, institutional/departmental guidelines, and other regulatory standards. The research team primarily supports studies on pediatric and adult asthma and other respiratory conditions. An ideal candidate is an independent worker who is comfortable working in a team setting. This position is fully remote and requires the ability to manage multiple, and often changing, priorities and timelines, and frequent communication with the project team regarding the status of assigned tasks and any issues that may arise. Key Responsibilities: Regulatory and research protocol adherence. Development of process and workflows. General research support. Regulatory and Research Protocol Adherence (45%): Conduct research activities in accordance with applicable institutional/departmental guidelines, federal regulations, and principles. Overread spirometry tests and record grades into research data portals in accordance with national standards (e.g., American Thoracic Society) and study protocols. Provide virtual spirometry coaching to study participants as outlined in study protocol. Report any protocol deviations or concerns to program director to ensure research quality. Development of Processes and Workflows (40%): Contribute to the development of workflows and protocols for data collection, including synchronous spirometry coaching, overreading, logistics, and data reporting. Assist with creating and performing quality assessment and improvement methods. Ensure consistent updates are communicated between team and research partners. General research support (15%): Provide instructions on home spirometry maneuvers to practitioners, coordinators, participants and caregivers. Attend Spirometry 360 team meetings, meetings with research collaborators and external vendors, as appropriate. Other duties as assigned. Minimum Requirements: Completion of a respiratory care program approved by the State of Washington Department of Health AND eighteen months of experience as a Respiratory Care Practitioner. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration. Legal Requirement Licensed as a Respiratory Care Practitioner (Registered Respiratory Therapist - RRT) by the State of Washington. Additional Requirements: Two years of experience coaching and reading spirometry maneuvers. Human Subjects Protection training (e.g., CITI) and Good Clinical Practice (ICH-GCP) certification, current at time of hire or completed prior to start. Training must be maintained per sponsor/IRB requirements. Desired Qualifications: NBRC Registered Respiratory Therapist (RRT) credential or active state Respiratory Care Practitioner (RCP) license. Experience working within clinical setting. Pediatric spirometry experience. Research experience. Strong organizational skills and attention to detail. Strong verbal and written communication skills with the ability to manage relationships and interact with a wide range of researchers, clinicians, and research participants. Proficiency in Microsoft Office software. Proficiency with audio/visual conference software, e.g. Zoom. Conditions of Employment Typical hours occur between 9am and 6pm The schedule may require occasional prearranged hours outside of business hours due to the nature of global spirometry testing. Local travel, within Western Washington State, may be required 1-2 times annually. This is a permanent position, albeit on an intermittent basis, as work becomes available. Compensation, Benefits and Position Details Pay Range Minimum: $40.98 hourly Pay Range Maximum: $58.60 hourly Other Compensation: - Benefits: For information about benefits for this position, visit **************************************************************************************** Shift: First Shift (United States of America) Temporary or Regular? This is a temporary position FTE (Full-Time Equivalent): 0.00% Union/Bargaining Unit: Not Applicable About the UW Working at the University of Washington provides a unique opportunity to change lives - on our campuses, in our state and around the world. UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty. Our Commitment The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81. To request disability accommodation in the application process, contact the Disability Services Office at ************ or **********. Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.

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

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

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.

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