Clinical research associate jobs in Bellevue, NE - 31 jobs

Clinical Research Associate - Oncology - West Region (AZ, CO, CA, UT) 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. **What You Will Be Doing:** + Serve as the primary point of contact between investigational sites and the sponsor + Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation in CTMS and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting + Support subject recruitment and retention efforts at the site level + Oversee drug accountability and ensure proper storage, return, or destruction + Resolve data queries and drive timely, high-quality data entry + Document site progress and escalate risks or issues to the clinical team + Assist in tracking site budgets and ensuring timely site payments (as applicable) + Collaborate with cross-functional partners including CTAs, LTMs, and CTMs **You are:** + A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN + Eligible to work in United States without visa sponsorship + A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry + Experienced monitoring oncology trials + Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF + A clear communicator, problem-solver, and collaborative team player + Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Nebraska near major HUB airports to support efficient regional travel **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

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Preferred Qualifications Research Portfolio Coordinator: Bachelor's degree in business administration, financial, research administration, or project management. Basic knowledge of project management and/or research administration experience working in higher education in a high-volume, high-production, and/or sponsored research-intensive environment. Experience preparing and delivering shared resources and tools helpful. Skill using project management software. SAP , WordPress, and social media platforms helpful. Experience in federal sponsor electronic portals, such ASSIST , research.gov, or grants.gov is helpful. Research Portfolio Manager I: Bachelor's degree in business administration, financial, research administration, or project management. Intermediate knowledge of project management and/or research administration experience working in higher education in a high-volume, high-production, and/or sponsored research-intensive environment. Experience preparing and delivering shared resources and tools helpful. Skill using project management software. SAP , WordPress, and social media platforms helpful. Experience in federal sponsor electronic portals, such ASSIST , research.gov, or grants.gov is helpful. Designation of CRPA , CPFA , CRA , CAPM , or PMP is desired. Research Portfolio Manager II: Bachelor's or Masters's degree in business administration, financial, research administration, or project management. Project management experience and/or research administration experience working in higher education in a high-volume, high-production, and/or sponsored research-intensive environment. Experience working in a business, financial, or grant management role in a university department, unit, center, or college. Experience in supervising. Experience preparing and delivering training programs and shared resources and tools helpful. Skill using project management software. SAP , WordPress, and social media platforms helpful. Experience in federal sponsor electronic portals, such ASSIST , research.gov, or grants.gov is helpful. Designation of CRPA , CPFA , CRA , CAPM , or PMP is desired.

The Clinical Research Associate will work at the Mind & Brain Health Labs ( MBHL , Department of Neurological Sciences) with the principal investigator and research team to coordinate, develop, and conduct clinical research projects aimed at improving patient health, disease treatment, and quality of life in individuals who are aging or have neurological, psychiatric, physiologic, or other medical disorders. Will assist with clinical research projects from start to finish to support successful communication, coordination, regulatory and protocol compliance, and work across a diverse, multidisciplinary team to meet project goals. See “unmc.edu/mbhl for more information on MBHL . Required Experience 3 years Work Schedule As directed by supervisor

Where You'll Work CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S., from clinics and hospitals to home-based care and virtual care services, CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources, CommonSpirit is committed to building healthy communities, advocating for those who are poor and vulnerable, and innovating how and where healing can happen, both inside our hospitals and out in the community. Job Summary and Responsibilities As our Trauma Services Coordinator, you will strategically lead and manage the comprehensive Trauma Services program, ensuring optimal patient outcomes, continuous quality improvement, and adherence to all trauma center designation requirements. Every day you will oversee trauma operations, clinical care coordination, and administrative functions across departments. You will manage trauma data for performance improvement, ensure compliance with ACS verification and regulations, and develop trauma policies. To be successful in this role, you will possess extensive clinical trauma experience and leadership within a designated trauma center. You will demonstrate a deep understanding of trauma systems, ACS verification, and quality improvement methodologies. Exceptional communication, analytical, and leadership skills to coordinate complex programs and influence clinical teams are essential. Facilitates research activities in partnership with the Trauma Medical Director and Research Administration colleagues leveraging clinical experiences in related specialty area. Is familiar with resources available in the institution and locally. Completes grant, journal, and publication writing duties and responsibilities as assigned. Maintain standards of publication and authorship. Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contracted and/or grant goals) through regular reporting and coordinated discussions. Promotes and adheres to responsible conduct of research (scientific ethics) policies. Maintain a professional attitude with patients, visitors and other hospital personnel while assuring confidentiality of patient information and other hospital information. Conceive, plan and conduct research for trauma-related grant opportunities and funding using advanced search techniques. Possess proficiency in searching funding sources through on-line databases and printed resource material. Assist the members of the Division of Trauma Surgery and Surgical Critical Care in the development of documents and proposals in response to Requests for Proposals from private foundations and governmental funding sources. Includes preparation of the RFP. ***THIS IS NOT A REMOTE ROLE*** Job Requirements Master's Degree Experience with statistical analysis Preferred Doctorate of Science

Job Summary and Responsibilities As our Trauma Services Coordinator, you will strategically lead and manage the comprehensive Trauma Services program, ensuring optimal patient outcomes, continuous quality improvement, and adherence to all trauma center designation requirements. Every day you will oversee trauma operations, clinical care coordination, and administrative functions across departments. You will manage trauma data for performance improvement, ensure compliance with ACS verification and regulations, and develop trauma policies. To be successful in this role, you will possess extensive clinical trauma experience and leadership within a designated trauma center. You will demonstrate a deep understanding of trauma systems, ACS verification, and quality improvement methodologies. Exceptional communication, analytical, and leadership skills to coordinate complex programs and influence clinical teams are essential. * Facilitates research activities in partnership with the Trauma Medical Director and Research Administration colleagues leveraging clinical experiences in related specialty area. Is familiar with resources available in the institution and locally. * Completes grant, journal, and publication writing duties and responsibilities as assigned. Maintain standards of publication and authorship. * Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contracted and/or grant goals) through regular reporting and coordinated discussions. * Promotes and adheres to responsible conduct of research (scientific ethics) policies. Maintain a professional attitude with patients, visitors and other hospital personnel while assuring confidentiality of patient information and other hospital information. * Conceive, plan and conduct research for trauma-related grant opportunities and funding using advanced search techniques. Possess proficiency in searching funding sources through on-line databases and printed resource material. * Assist the members of the Division of Trauma Surgery and Surgical Critical Care in the development of documents and proposals in response to Requests for Proposals from private foundations and governmental funding sources. Includes preparation of the RFP. * THIS IS NOT A REMOTE ROLE* Job Requirements Required * Master's Degree * Experience with statistical analysis Preferred * Doctorate of Science Where You'll Work CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S., from clinics and hospitals to home-based care and virtual care services, CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources, CommonSpirit is committed to building healthy communities, advocating for those who are poor and vulnerable, and innovating how and where healing can happen, both inside our hospitals and out in the community.

We are seeking an experienced Clinical Research Coordinator to support our high‑performing research team. Reporting to the Principal Investigator, you will ensure all study activities follow Good Clinical Practice (GCP) standards while coordinating day‑to‑day clinical research operations. Key Responsibilities + Build strong communication channels with study team members. + Coordinate daily research visit activities, including vital signs, EKGs, phlebotomy, injections, and lab assessments. + Ensure participant compliance with study protocols. + Maintain and organize source documents; promptly report adverse events. + Ensure participant safety throughout the study. + Educate participants on study procedures, interventions, and study drugs. + Verify that all collected data is accurate, legible, and GCP‑compliant. Must‑Have Qualifications + Minimum 2 years of Clinical Research Coordinator experience. + Phlebotomy, EKG, and injection experience. + Strong knowledge of Good Clinical Practice (GCP). + Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, SharePoint). + Experience with clinical trial master file systems. + Understanding of study drug background and study requirements. Job Type & Location This is a Contract to Hire position based out of OMAHA, NE. Pay and Benefits The pay range for this position is $25.00 - $29.00/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 onsite position in OMAHA,NE. Application Deadline This position is anticipated to close on Jan 29, 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.

Why VTV: At Vance Thompson Vision, we take pride in being global leaders in vision correction, driven by our commitment to groundbreaking research, innovative technology, and exceptional patient care. With a reputation for setting the standard of excellence in our field, we continue to transform lives through better vision. We believe that exceptional care begins with an exceptional team. Be part of something greater-join us and discover what it means to create a world-class culture while making a meaningful impact. Our core values that provide our foundation: Caring - We are passionate, empathetic, and sensitive to the needs of our teammates, patients, and everyone we touch. Fun - We choose a positive attitude every day. We use humor as a way to create a less formal, less stressful and more productive work environment. Committed - We are accountable and 100% committed to the Success of VTV. We are boundaryless; we are willing to take initiative to delight our customers, motivate fellow teammates and improve financial results. Egalitarian - We play on a team where everyone is equal, where no task is too small for any member to step up and own inside and outside their functional area. Excellence - We are committed to doing the extra work to be outstanding in customer service, patient care and team happiness. Job Opportunity: We are growing, and we are looking for a Clinical Research Coordinator to join our team! You Are: Ready to live out our core values in patient and team member interactions Committed to excellent patient experience. Highly organized and able to anticipate patient needs. Able to bring a positive attitude every day. You Will Make an Impact By: Assisting with study initiation activities, such as coordinating the delivery of study-related paperwork, equipment, demos, supplies, and participating in study-initiation meetings. Overseeing and participating in patient recruitment, screening, scheduling, and informed consent activities. Serving as the primary patient contact in areas such as counseling the patient on visit requirements, study purpose, and study costs, etc., and providing high-quality patient care by promptly addressing patient information needs. Preparing patient charts for patient visits, ensuring complete data collection, and assisting clinical research technicians with case report form completion as requested. Assisting in monitoring visits with sponsor staff (e.g., queries, source document reconciliation, preparing regulatory documents, answering questions) Ensuring protocol and regulatory compliance to assigned clinical study protocols. Serving as the primary liaison between clinical study sponsors, patients, and VTV staff regarding study protocol requirements and communicates clinical study information with study participants, physicians, clinical study project team, and clinical research manager in an appropriate format (e.g., meeting minutes, status reports, telephone calls, e-mails, memos, and letters). Maintaining study regulatory file and test article accountability per internal standards. Maintaining accurate clinical study electronic and hard copy documentation in accordance with clinical study protocols, applicable regulations, and departmental procedures. Assisting with report preparation and clinical study communications to external agencies (e.g., FDA, IRB) as requested. Representing clinical research department on internal project teams as requested. You Have: A bachelor's degree in health-related field 2+ years in a clinical research environment, managing multiple studies, preferred. Working knowledge in research methodology, GCP, FDA/IRB regulations, clinical trial design, preferred. Investments in YOU: Vance Thompson Vision offers a full benefits package and competitive compensation, including: $150 shoe allowance for full-time employees 401k with company contributions Education Allowance Wellness Program paired with a Lifestyle Spending Account Vance Thompson Vision is an equal opportunity and affirmative action employer. We are committed to creating a diverse and inclusive culture for all employees.

Salary: DOE ALIVATION RESEARCH, LLC Integrated Health Center | Next Level You Lincoln, NE 68526 A leader in integrated Mental Healthcare for over 20 years with Pharmacy, Primary Care, Aesthetics and Research divisions all in one location, where ideas and opinions are valued and expected, seeks a Clinical Research Assessment Coordinator to join our expanding Behavioral Health Research Team promoting an innovative culture, putting the patients health and well-being first. CORE VALUES: Drive | Passion | Humility | Openness | Discipline JOB TITLE: Clinical Research Assessment Coordinator STATUS: Regular Full-Time If you have a perceptive passion to promote research studies in a collaborative team environment, with an innate learning desire that resonates with our core values to deliver and enhance the best patient care, we would like to meet you. Ultimately, you will assume an important role in the promotion of clinical research performing all activities involved in conducting clinical studies in a safe and therapeutic physical environment, specifically the patient visits rating scales and assessments for the research trials. TALENT: Eager, determined to achieve success, and committed to making a difference every day Compassionate and care deeply about our patients and their experience Love what you do and where you work Not afraid to ask questions and grow as a professional Ability to have open, honest conversations with patients and team members Self-motivated Integrity belief in everything you do KEY RESPONSIBILITIES: (Job Description Available Upon Demand) Implements and supports the practice mission and strategic vision within respective departments. Handles confidential information requiring professional discretion and compliance with protected health information, data integrity and security policies. Implements Phase I, II, III and IV pharmaceutical, device, and non-interventional research trials in accordance with GCP guidelines. Recruit patients to participate in research studies in person, over the phone, and through community outreach and/or events: This includes explaining the study design, purpose, and requirements, as well as pre-screening for eligibility and answering any questions the patient may have. Schedules patient visits: This includes coordinating provider schedules and research schedules. Conducts patient visits while observing all protocol and GCP requirements and guidelines. Dispenses and receives study medication. Monitors adverse events and concomitant medications at each visit. Performs rating scales and assessments during the patient visits (especially those in which a MD, PhD, Masters, or equivalent degree is required). Performs/assists with safety assessments during the patient visits, including height, weight, blood pressure, temperature, respiratory, ECG, blood draw and urine collection. Completes all data entry required after each visit: This includes answering sponsor queries. Manages a caseload of various studies and be able to organize and submit all required documents for each specific study to the sponsor, IRB, study team, and any other applicable parties. Assists with maintaining and organizing regulatory documents for research trials. Submits all required documentation to study team, sponsor and IRB. Maintains patient and regulatory master files to assure audit readiness. Attend periodic investigator meetings out-of-state. Demonstrates adaptability to changing work demands in terms of priorities that necessitate personal initiative. Demonstrates excellent interpersonal skills, strong active listening skills, verbal, and written communication skills, patience and trustworthiness to effectively share knowledge with Chief Medical Officer, Neuroscience Clinical Research Manager and patients. Other clinical or administrative duties as assigned to meet practice needs. QUALIFICATIONS: MD (No License Required), PhD, Masters or Equivalent Degree in Mental Health Field Required | Knowledge of FDA Regulations and GCP Guidelines | Proficient Medical Terminology | Basic Life Support (BLS) Certification or In Process | Electronic Data Capture Systems | ECG Machine | Electronic Manometer | Thermometer | Scale | Familiar with EMR & PM Systems | Familiar with Microsoft Platforms EXPERIENCE: 3 years experience conducting clinical research studies| Previous experience in Psychiatric Treatment preferred. Previous experience administering some or all of the following rating scales and assessments required: ABC-I, ADHD-RS-IV, ACDS, AIMS, AISRS, ASRS, ATRQ, BARS, BPRS+, CAPS-5, CADSS, CDRS-R, CGI-I/CGI-S, C-SSRS, CY-BOCS, HAM-A, HAM-D, HDRS-21, Ishihara Color Blindness Test, K-SADS, Kaufmann Brief Intelligence Test, LEC-5, MADRS, MINI-KID, MINI, MMSE, MoCA, PAC, PANSS, PARS, Peds-QL, PHQ-9, PPVT, PROMIS, PWC-20, QIDS-SR, SAS, SIGH-D-17, SNAP-IV, S-STS, SCID, Tanner Staging, TOVA, UKU, YGTSS, Y-BOCS, YMRS COMPENSATION: Competitively Based COMPREHENSIVE BENEFITS PACKAGE: Clinic-Owned, Innovative Aesthetics Environment Discounted Primary Care Office Visits for Employees Amazing Team Culture No On-Call Shifts No Nights or Weekends Corporate Employee Discounts Free Parking 120 Hours PTO Seven Paid Holidays Health Insurance (Employee Premium Allotment) Dental Insurance Vision Insurance Short-Term & Long-Term Disability Insurance Paid Life Insurance Policy Employee Assistance Program (EAP) Health Savings Account 401(k) Matching Retirement Plan EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER: The Practice provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are seeking a Clinical Research Coordinator to join our Lincoln, NE team! This is a great opportunity for someone seeking a career change. Training is provided.As a Clinical Research Coordinator you are responsible for oversight and conduct of clinical studies. You will ensure compliance, quality, and profitability of clinical studies. You respond to internal and external client issues, concerns, and requests by applying study management techniques and tools. In this role you should plan to work some evening and weekends. Primary Responsibilities:You are responsible for the overall management of Clinical Studies to include: on-time performance with defect-free execution, independently conducting bioequivalency and bioavailability studies, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), organizing study initiation meetings to plan execution of study, facilitating study review meetings for pre-study, in-process and post study review, problem solving as needed during study conduct, meeting with clients as needed throughout study, and organizing study logistics and personnel. In addition, you will be present at critical events and dosings of study. You will build client relationships that result in additional business, you will craft and edit reports, respond to client issues, concerns and requests, adhere to milestone guidelines, and ensure profitability by maintaining profitability of team through a budgeting and expense control on a total and individual study basis. Requirements You will have a Bachelor's degree in a related discipline or BSN required. Celerion experience may be considered in lieu of degree in some situations. Industry experience and knowledge of medical terminology preferred. Demonstrated organizational, time management and multi-tasking skills required Shown ability to handle multiple priorities Excellent oral and written communication skills You will work without close supervision Ability to work flexible hours required for study conduct You will utilize customer service skills Clinical Research experience useful, but not required Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

, you must reside in the same country where the job is located. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree Degree in scientific discipline or health care preferred. - Requires at least 2 years of year of on-site monitoring experience. - Equivalent combination of education, training and experience may be accepted in lieu of degree. - Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. - i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Good therapeutic and protocol knowledge as provided in company training. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). - Written and verbal communication skills including good command of English language. - Organizational and problem-solving skills. - Effective time and financial management skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Preferred Qualifications The following qualifications are preferred, but not required: Master's degree in animal science or related field plus animal production experience preferred.

Responsible for assisting UNMC Clinical Research Coordinators and Principal Investigators as needed in the Neurological Sciences Clinical Research Center with project management, coordination, and implementation of clinical trials. Provide clinical, laboratory, and administrative support to the Neurological Sciences Clinical Research Center to ensure trials move forward toward enrollment goals. Required Experience 2 years Work Schedule As directed by supervisor

We are seeking an experienced Clinical Research Coordinator to support our high‑performing research team. Reporting to the Principal Investigator, you will ensure all study activities follow Good Clinical Practice (GCP) standards while coordinating day‑to‑day clinical research operations. Key Responsibilities * Build strong communication channels with study team members. * Coordinate daily research visit activities, including vital signs, EKGs, phlebotomy, injections, and lab assessments. * Ensure participant compliance with study protocols. * Maintain and organize source documents; promptly report adverse events. * Ensure participant safety throughout the study. * Educate participants on study procedures, interventions, and study drugs. * Verify that all collected data is accurate, legible, and GCP‑compliant. Must‑Have Qualifications * Minimum 2 years of Clinical Research Coordinator experience. * Phlebotomy, EKG, and injection experience. * Strong knowledge of Good Clinical Practice (GCP). * Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, SharePoint). * Experience with clinical trial master file systems. * Understanding of study drug background and study requirements. Job Type & Location This is a Contract to Hire position based out of OMAHA, NE. Pay and Benefits The pay range for this position is $25.00 - $29.00/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 onsite position in OMAHA,NE. Application Deadline This position is anticipated to close on Jan 29, 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 for other accommodation options.

Salary: DOE ALIVATION RESEARCH, LLC Integrated Health Center | Next Level You Lincoln, NE 68526 A leader in integrated Mental Healthcare for over 20 years with Pharmacy, Primary Care, Aesthetics and Research divisions all in one location, where ideas and opinions are valued and expected, seeks a versatile and compassionate candidate to join our vibrant Behavioral Health Research Team promoting an innovative culture, putting the patients health and well-being first. CORE VALUES: Drive | Passion | Humility | Openness | Discipline JOB TITLE: Clinical Research Coordinator STATUS: Regular Full-Time If you have a passion for delivering excellent patient care as well as furthering science through pharmaceutical and device research studies, we would like to meet you. Ultimately, you will play an important role on our team as a coordinator who is entrusted with learning a variety of different Behavioral Health Research trials, maintaining documentation for research studies, engaging with sponsors, conducting research trial visits with patients, and maintaining effective communication with the research team and providers in the clinic. TALENT: Eager, determined to achieve success, and committed to making a difference every day. Compassionate and care deeply about our patients and their experience. Love what you do and where you work. Not afraid to ask questions and grow as a professional. Ability to have open, honest conversations with patients and team members. Self-motivated. Integrity belief in everything you do. KEY RESPONSIBILITIES: (Job Description Available Upon Demand) Supports and implements the practice mission and strategic vision within their respective departments. Handles confidential information requiring professional discretion and compliance with protected health information, data integrity and security policies. Implements Phase II, III and IV pharmaceutical, device, and non-interventional research trials in accordance with GCP guidelines. Recruitment of patients to participate in research studies in person and over the phone, schedules patient visits, prepares for patient visits, conducts patient visits, and completes all data entry required after each visit. Manages a caseload of patients on a variety of different studies. Perform/assist with safety assessments during the patient visits, including height, weight, blood pressure, temperature, respiratory, ECG, blood draw and urine collection. Complete all data entry required after each visit, including answering sponsor queries. Maintains excellent communication with manager, team members, sponsor, and the IRB. Meticulously documents all patient correspondence. Periodically attends investigator meetings out of state. Other clinical or administrative duties as assigned to meet practice needs. QUALIFICATIONS: High School Diploma | Bachelor's Degree or Medical Experience Preferred | Proficient Medical Terminology | Knowledge of GCP Regulations | Familiar with EMR Systems EXPERIENCE: Minimum Three Years Working In A Clinical Research Setting COMPENSATION: Competitively Based COMPREHENSIVE BENEFITS PACKAGE: Clinic-Owned, Innovative Aesthetic Environment Discounted Primary Care Office Visits for Employees Amazing Team Culture Company Sponsored Events No On-Call Shifts No Nights or Weekends Corporate Employee Discounts Free Parking 91 Hours PTO Seven Paid Holidays Health Insurance (Employee Premium Allotment) Dental Insurance Vision Insurance Short-Term & Long-Term Disability Insurance Paid Life Insurance Policy Employee Assistance Program (EAP) Health Savings Account 401(k) Matching Retirement Plan EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER: The Practice provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are seeking a Clinical Research Coordinator to join our Lincoln, NE team! This is a great opportunity for someone seeking a career change. Training is provided. As a Clinical Research Coordinator you are responsible for oversight and conduct of clinical studies. You will ensure compliance, quality, and profitability of clinical studies. You respond to internal and external client issues, concerns, and requests by applying study management techniques and tools. In this role you should plan to work some evening and weekends. Primary Responsibilities: You are responsible for the overall management of Clinical Studies to include: on-time performance with defect-free execution, independently conducting bioequivalency and bioavailability studies, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), organizing study initiation meetings to plan execution of study, facilitating study review meetings for pre-study, in-process and post study review, problem solving as needed during study conduct, meeting with clients as needed throughout study, and organizing study logistics and personnel. In addition, you will be present at critical events and dosings of study. You will build client relationships that result in additional business, you will craft and edit reports, respond to client issues, concerns and requests, adhere to milestone guidelines, and ensure profitability by maintaining profitability of team through a budgeting and expense control on a total and individual study basis. Requirements * You will have a Bachelor's degree in a related discipline or BSN required. Celerion experience may be considered in lieu of degree in some situations. * Industry experience and knowledge of medical terminology preferred. * Demonstrated organizational, time management and multi-tasking skills required * Shown ability to handle multiple priorities * Excellent oral and written communication skills * You will work without close supervision * Ability to work flexible hours required for study conduct * You will utilize customer service skills * Clinical Research experience useful, but not required Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Assists in the study of the utilization of prescribed opioid medications following surgery with the goal of improving opioid prescription safety for patients. Required Experience 2 years Work Schedule Monday - Friday, 8:00 AM - 4:30 PM

Job DescriptionCelerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are seeking a Clinical Research Coordinator to join our Lincoln, NE team! This is a great opportunity for someone seeking a career change. Training is provided.As a Clinical Research Coordinator you are responsible for oversight and conduct of clinical studies. You will ensure compliance, quality, and profitability of clinical studies. You respond to internal and external client issues, concerns, and requests by applying study management techniques and tools. In this role you should plan to work some evening and weekends. Primary Responsibilities:You are responsible for the overall management of Clinical Studies to include: on-time performance with defect-free execution, independently conducting bioequivalency and bioavailability studies, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), organizing study initiation meetings to plan execution of study, facilitating study review meetings for pre-study, in-process and post study review, problem solving as needed during study conduct, meeting with clients as needed throughout study, and organizing study logistics and personnel. In addition, you will be present at critical events and dosings of study. You will build client relationships that result in additional business, you will craft and edit reports, respond to client issues, concerns and requests, adhere to milestone guidelines, and ensure profitability by maintaining profitability of team through a budgeting and expense control on a total and individual study basis. Requirements You will have a Bachelor's degree in a related discipline or BSN required. Celerion experience may be considered in lieu of degree in some situations. Industry experience and knowledge of medical terminology preferred. Demonstrated organizational, time management and multi-tasking skills required Shown ability to handle multiple priorities Excellent oral and written communication skills You will work without close supervision Ability to work flexible hours required for study conduct You will utilize customer service skills Clinical Research experience useful, but not required Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.