Clinical trial coordinator work from home jobs - 171 jobs

SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). Support adoption of new technology or clinical applications through advocacy and evidence. Participate in customer presentations regarding use of Interventional products for institution research purposes. Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. Grow technology leadership mindshare through joint scientific presentations and publications. Install/upgrade research equipment and software & prototypes Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. Study new technology concepts and leverage expertise to move initiatives forward. Note: No sponsorship available for this role now or in the future to work in the United States.. Qualifications PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. 3+ years of experience in Interventional healthcare industry or research. Knowledge of Interventional procedures, anatomies, clinical practice. Excellent written and verbal communication skills. Excellent customer relationship management and collaboration skills. Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Quality, Compliance, and Continuous Improvement focus Desired Characteristics 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. #LI-BR3 #LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No

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

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.

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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

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

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

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.

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

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.

The Program Coordinator is responsible for conducting detailed reviews of clinical trial protocols to determine the appropriate billing of services in compliance with Medicare regulations and institutional policies. This role ensures that billing practices align with federal guidelines and supports the financial integrity of clinical research operations. Responsibilities + Perform Medicare Coverage Analysis (MCA) for new and ongoing clinical trials. + Interpret clinical trial protocols to identify billable services and distinguish between routine care and research-related costs. + Apply CMS National Coverage Determination (NCD) 310.1 and other relevant guidelines. + Collaborate with study teams, investigators, and billing departments to ensure accurate billing plans. + Develop and maintain billing grids and coverage analysis documentation. + Assist in budget development and negotiation with sponsors. + Ensure consistency across informed consent forms, contracts, and billing plans. + Support audits and respond to compliance inquiries related to clinical trial compliance. Essential Skills + Bachelor's degree in healthcare, life sciences, finance, or a related field (Master's preferred). + 2+ years of experience in clinical research billing, coverage analysis, or healthcare compliance. + Strong knowledge of Medicare regulations and clinical trial billing practices. + Familiarity with clinical trial management systems (CTMS) and electronic medical records (EMR). + Excellent analytical, organizational, and communication skills. Work Environment This position is remote and available in the following states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia. Job Type & Location This is a Contract to Hire position based out of Orlando, FL. Pay and Benefits The pay range for this position is $38.00 - $44.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jan 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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

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

The Stanford 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 Learning is 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 (***************************************************** provides 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. Our culture and unique perks empower 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

**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 (********************************************************* . University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.

The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote

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

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

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