Clinical research associate jobs in Omaha, NE

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#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.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

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. Job Requirements Required Master's Degree Experience with statistical analysis Preferred Doctorate of Science Not ready to apply, or can't find a relevant opportunity? Join one of our Talent Communities to learn more about a career at CommonSpirit Health and experience #humankindness.

Part-time Description Job Title: Clinical Research Coordinator (CRC) Department: Clinical Research Reports to: Clinical Manager Summary: The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the clinical Principal Investigator's (PI) direction. While the principal investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.Essential Duties and Responsibilities Rights, safety and well-being of patients prevail over science. Rights, safety and well-being of patients prevail over science. All available non-clinical and clinical information on any investigational agent can support the trial as designed. All trials are scientifically sound and clearly described. All clinical trials have current Institutional Review Board approval. Everyone involved in the clinical Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians. Trial is qualified by training, education and experience. Informed consent is given freely by every participant. All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification. Confidentiality of subjects is respected and protected. Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling. Systems to ensure quality are implemented in all aspects of the trial. Register participants to the appropriate coordinating center (if multi-site study) Complete study documentation and maintains study files in accordance with sponsor requirements and policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms and investigational material accountability forms. Retains all study records in accordance with sponsor requirements. Maintains effective and ongoing communication with sponsor, research participants, research director and PI during the course of the study. Competencies Required: Dependability and punctuality Planning and organizing Customer Service Multitasking Oral Communication Adaptability Problem solving Attention to Detail Ability to follow through Teamwork Professionalism Good written communication skills High energy Qualifications/Education/Experience: Qualifications: High school graduate or equivalent. Supervisory: The incumbent in the position will not supervise other employees. Education/Experience: Bachelor's degree in life science or related discipline and experience in clinical research is preferred. Skills/Abilities: Language Ability: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Knowledge of modern equipment and the ability to maintain confidentiality, maintain physical effort, and distribute files. Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: Proficient in Microsoft Office, Outlook, Excel, PowerPoint, and Word; able to navigate the internet and intranet. Ability to learn the internal clinical outcome database and upload photographs from a camera. Environment Expectations: Work Environment: The incumbent in this position is not required to work under extreme conditions, but must be able to work around a moderate noise level, such as in an office environment. Physical Demands: The incumbent in this position typically has to stand approximately 20% of the time, walk 20% of the time, and sit 60%. In addition, this person talks or hears 100% of the time. Accountability: The Clinical Research Coordinator is accountable for the day-to-day operations of ensuring the clinical trial program runs smoothly, via phone messages, faxes to physicians and staff, database entry, billing entry, etc. Specific Individual Considerations: The designation of "essential functions" and "other duties" is for purposes of compliance with the Americans with Disabilities Act. This job description should not be construed to imply that these requirements are the only duties, responsibilities, and qualifications for this position. Incumbents may be required to follow any additional related instructions, acquire related job skills, and perform other related work as required. Incumbents in this position may be required to perform all or some of the above duties and responsibilities with varying concentration levels based on the incumbent's skill level and program needs. I have read and understand the contents of this position description. _____________________________ Signature Print Name Date Salary Description $20-22 per hour

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 patient's 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.

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

**Job Purpose:** The Senior Clinical Research Associate I (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.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Responsible for coordination of patient care during participation in a clinical research trial which includes the complex aspects of health care as it relates to pediatrics and pediatric sub-specialties. The coordinator assumes responsibility for critical coordination and management of the complex decisions and regulatory requirements of each research protocol. The coordinator is involved in all aspects of each research protocol facilitating the mission of UNMC and CHRI investigators to effectively participate in clinical research and investigational protocols for a variety of Pediatric specialties. Additional Info About Us: To learn more about the University of Nebraska, visit the sites below. University of Nebraska Strategic Plan "Odyssey to Extraordinary" *********************************** Get to know Nebraska ***************************************** University of Nebraska Medical Center Campus *************************************** and *************************************** University of Nebraska Faculty & Staff Benefits ************************************** Required Qualifications: * Bachelor's degree * 1 year clinical experience and/or research experience in a clinical or laboratory setting. * Microsoft Excel,Microsoft Word Will consider five years education and/or related experience combined of which two years must include post high school education. * Flexibility in work hours to manage the patient and study protocol workload * Reliable and effective verbal and written communication skills * Ability to prioritize and make independent judgments Possess skills of good organization, flexibility, accountability, being a team player, and self-initiative * Ability to work effectively and collaborate with the interdisciplinary team * Demonstrate knowledge and skill in addressing age specific needs of patients served, (all age groups-birth and above) * Assure performance of behaviors that meet the requirements of the UNMC culture including: demonstrates behavior that fosters a positive team environment, demonstrates behaviors that promote diversity, applies continuous quality improvement principles, seeks the customers requirements and strives to meet them, and designs personal action plan for personal and professional development. * Maintains accountability for own actions in completing assigned tasks. Preferred Qualifications: * Pediatric background and experience related to clinical trials coordination. * Certification/maintenance of certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) * Microsoft Outlook * Experience with EPIC, REDcap and other research EDC preferred. * This position is key to the successful supervision of clinical research trials through monitoring patient care and treatment, protocol regulations, and providing education for patient, family and health care team. * Clinical research is based on the collection of information, requiring expert interpretation. Information must be accurately interpreted and recorded to ensure that research results are free of errors. Errors in the interpretation and recording of data may significantly alter research results. Therefore, data entry must be accurate and precise to positively impact patient care and research conclusions. Compliance Requirements: * Physical Exam * Drug Screen * Background Check * Child & Adult Sexual Abuse Registry Request and Check * Education Credentials Check * Visual/Color Examination * Fit Test (Respiratory Protection) * Immunizations Information at a Glance Apply now Req Id: 1562 Campus Name: University of Nebraska Medical Center (UNMC) Org Unit: CHRI Administration UNMC Job Location: Children's Main Campus - Omaha, NE 68198 Application Review Date: 10/30/25 Open Until Filled: Yes Advertised Salary: $48,200 - $72,300/annual Job Type: Full-Time Worksite Eligibility: Hybrid Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: ************* Special Instructions to Applicant: Please attach resume. The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 10/28/25 Search Jobs

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 patient's 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.

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#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.

Responsible for all aspects of research projects and research facilities that includes multiple hospital systems. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data. Additional Info About Us: To learn more about the University of Nebraska, visit the sites below. University of Nebraska Strategic Plan "Odyssey to Extraordinary" *********************************** Get to know Nebraska ***************************************** University of Nebraska Medical Center Campus *************************************** and *************************************** University of Nebraska Faculty & Staff Benefits ************************************** Required Qualifications: * Bachelor's degree in Health Science or related field * 3 years clinical research project management to include data collection and/or data management. * Microsoft Excel,Microsoft Outlook,Microsoft PowerPoint,Microsoft Word * REDCap, Epic, Cayuse/eIRB, Microsoft Office Suite, SharePoint, Adobe Acrobat, Remote Patient Monitoring Platforms Will consider seven years related education/experience of which two years must include related post high school education. Preferred Qualifications: * Master's degree * Organization * Problem-Solving * Collaboration * Attention to Detail * Ability to work autonomously. Compliance Requirements: * Physical Exam * Drug Screen * Background Check * Child and Adult Sexual Abuse Registry Request and Check * Education Credentials Check * Immunizations Information at a Glance Apply now Req Id: 1746 Campus Name: University of Nebraska Medical Center (UNMC) Org Unit: Obstetrics/Gynecology UNMC Job Location: Omaha, NE 68198 Application Review Date: 11/10/25 Open Until Filled: Yes Advertised Salary: $60,500 - $90,800/annual Job Type: Full-Time Worksite Eligibility: On-site Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: ************* Special Instructions to Applicant: The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 11/6/25 Search Jobs

The Nebraska Food for Health Center (NFHC) advances human and animal health by connecting agriculture, food production, and microbiome research. Established in 2016, the Center brings together researchers across the University of Nebraska system to develop crops and foods designed to improve gut health, promote wellness, and prevent disease. As a Clinical Research Coordinator, you will: * Review and analyze initial study proposals to be conducted at the facility. * Aid in developing practical budgets and timelines. * Train Clinical Research Coordinators, staff, PIs, post-docs and students as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, SOPs or other work instruction set. * Work with both Environmental Health and Safety (EHS) and the UNL Institutional Review Board (IRB) to ensure compliance of the facility and of study protocols. * Oversee clinic functions, promotion, and marketing. About Us: At the University of Nebraska-Lincoln, we're proud to be consistently recognized by Forbes as a top employer, known for our welcoming and supportive work environment, commitment to professional growth, and outstanding benefits. UNL isn't just a workplace, it's a place to build your career and make a real impact in Nebraska. When you join our team as a full-time, regular staff member, you'll enjoy: * Ample paid time off, including vacation, sick leave, parental leave, and holidays * Comprehensive insurance options including medical, dental, vision, and life insurance * Employee & dependent scholarship program to pursue higher education * Generous retirement plans with university match Discover more about working at UNL and our benefits: ************************** Required Qualifications: * Bachelor's degree in biological sciences, nursing, or related field; and * Seven (7) years of experience coordinating clinical trials which includes the following: * Five (5) or more years working with an Institutional Review Board (IRB); and * Five (5) or more years mentoring or training other research professionals; and * One (1) or more years of phlebotomy experience. * Experience with clinical databases such as RedCap. * Certified Clinical Research Coordinator certification is required. * Ability to communicate effectively with study participants, other staff, and leading Principal Investigators and/or Physicians. * Ability to understand research protocols and follow clinical trial regulations. * Knowledge of current computer technology. * Strong interpersonal skills with attention to detail. Preferred Qualifications: The following qualifications are preferred but not required: * Bachelor's degree in nursing. * Experience organizing office space. Compliance Requirements: If selected for this position and a verbal offer is accepted, the final written offer will be contingent upon the successful completion of the following required pre-employment check(s): * Criminal history background check Information at a Glance Apply now Req Id: 1658 Campus Name: NU Institute of Agriculture & Natural Resources (IANR) Org Unit: Nebraska Food for Health Center IANR Job Location: Lincoln, NE 68583 Application Review Date: 1/7/26 Open Until Filled: Yes Advertised Salary: $68,000/year minimum Job Type: Full-Time Worksite Eligibility: On-site Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: Melissa Weiler, **************** Special Instructions to Applicant: Click on "Apply Now". Create or login to account. If current employee, click on Employee login. The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 11/3/25 Search Jobs

The Project Manager is responsible for assisting the UNMC Principal Investigators and the Administrator in the overall project management, and implementation of Nephrology and Kidney Transplant clinical trials and research projects, as well as function as the primary contact for the industry trials that will ensure successful participation of our site in clinical trials. Research projects and campus collaboration. Provide tracking and preparation of study specific documents according to FDA regulations. Oversees training of personnel and project teams as appropriate. Works to ensure trials and projects move forward based on both time and budget. Plays an integral role in the communication between sponsors, sites and team members and act as a liaison with other divisions necessary to complete the study. In addition to project manager responsibilities, this individual is responsible for supervision assigned team members of the Division of Nephrology clinical trials working group. This may include direct supervision and overseeing training of site personnel and project team members as appropriate. View full description by selecting Additional Info below. Additional Info About Us: To learn more about the University of Nebraska, visit the sites below. University of Nebraska Strategic Plan "Odyssey to Extraordinary" *********************************** Get to know Nebraska ***************************************** University of Nebraska Medical Center Campus *************************************** and *************************************** University of Nebraska Faculty & Staff Benefits ************************************** Required Qualifications: * Bachelor's degree in Health Science or related field. * 2 years clinical research project management to include data collection or data management * Microsoft Excel,Microsoft Word,Microsoft Outlook Will consider six years related education and/or experience combined of which two years must include related post high school education * Excellent organizational skills * Knowledge of clinical research * Excellent verbal and written communication skills required * Computer literacy and familiarity with maintenance of computer databases * Ability to work effectively with other team members * Ability to prioritize multiple tasks/responsibilities * Strong interpersonal skills Preferred Qualifications: * Bachelor's degree in Nursing, Healthcare Administration * Nephrology * Knowledge of clinical research trials * Medical terminology * Database Systems * Previous experience working with physicians * Previous work in kidney disease and/or kidney transplantation Compliance Requirements: * Physical Exam * Drug Screen * Background Check * Child & Adult Sexual Abuse Registry Request and Check * Education Credentials Check * Immunizations Information at a Glance Apply now Req Id: 1555 Campus Name: University of Nebraska Medical Center (UNMC) Org Unit: Int Med Nephrology UNMC Job Location: Omaha, NE 68198 Application Review Date: 10/30/25 Open Until Filled: Yes Advertised Salary: $53,000 - $79,500/annual Job Type: Full-Time Worksite Eligibility: Hybrid Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: ************* Special Instructions to Applicant: Resume and Cover Letter Required The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 10/24/25 Search Jobs

Supervise and coordinate clinical research efforts in Infectious Diseases, specifically clinical research coordinator support for multicenter, international, and interventional clinical trials (NIHand industry-sponsored).Optimize operations in all phases of clinical research, from project concept, grant preparation, regulatory review, data acquisition, and analysis.Work with internal and external entities to identify funding sources, prepare grant proposals, and initiate and manage all phases of clinical research projects. Additional Info About Us: To learn more about the University of Nebraska, visit the sites below. University of Nebraska Strategic Plan "Odyssey to Extraordinary" *********************************** Get to know Nebraska ***************************************** University of Nebraska Medical Center Campus *************************************** and *************************************** University of Nebraska Faculty & Staff Benefits ************************************** Required Qualifications: * Relevant coursework/specialized training in Nursing * 2 years nursing experience * Registered nurse with current licensure or licensure eligible. * Strong organizational skills and self-motivation. * Excellent communication and interpersonal skills and committed to providing quality work through dedication and attention to detail. Preferred Qualifications: * Bachelor's degree in Nursing * Experience with Infectious Diseases, Healthcare Epidemiology, Antimicrobial Stewardship * CCRC certification * Carecast * Knowledge of conduction and oversight of clinical research, including multi-center interventional trials. * Knowledge of research processes such as IRB, data collection and data documentation, creation of source documents, and interactions with clinical trial monitors. * Strong working knowledge of GPCguidelines and FDA regulations. Basic database computer skills. Compliance Requirements: * Physical Exam * Drug Screen * Background Check * Child & Adult Sexual Abuse Registry Request and Check * Education Credentials Check * Fit Test (Respiratory Protection) * Immunizations Information at a Glance Apply now Req Id: 1406 Campus Name: University of Nebraska Medical Center (UNMC) Org Unit: Int Med Infectious Diseases UNMC Job Location: Omaha, NE 68198 Application Review Date: 10/20/25 Open Until Filled: Yes Advertised Salary: $69,400 - $104,100/annual Job Type: Full-Time Worksite Eligibility: On-site Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: ************* Special Instructions to Applicant: Resume Required The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 10/15/25 Search Jobs

Responsible for coordination of patient care and treatment during participation in a clinical research trial which includes the complex aspects of health care as it relates to pediatrics. The coordinator assumes responsibility for critical coordination and management of the complex decisions and regulatory requirements of each research protocol. The coordinator is involved in all aspects of each research protocol facilitating the mission of UNMC and CHRI investigators to effectively participate in clinical research Additional Info About Us: To learn more about the University of Nebraska, visit the sites below. University of Nebraska Strategic Plan "Odyssey to Extraordinary" *********************************** Get to know Nebraska ***************************************** University of Nebraska Medical Center Campus *************************************** and *************************************** University of Nebraska Faculty & Staff Benefits ************************************** Required Qualifications: * Relevant coursework/specialized training in Nursing * 1 year prior nursing experience in a patient facility or clinical setting. * Current Nebraska RN license or license eligible. * Microsoft Excel, Microsoft Word * Knowledge of current nursing procedures, techniques and practices * Ability to perform physical assessments and patient teaching as appropriate to research protocol * Advanced knowledge of clinical trials and chart review * Flexibility in work hours to manage the patient and study protocol workload Reliable and effective verbal and written communication skills * Ability to train, evaluate, and monitor other clinical research staff within the Pediatric Research Office. * Ability to prioritize and make independent clinical judgments * Possess skills of good organization, flexibility, accountability, being a team player, and self-initiative * Computer literacy desirable. * Ability to work effectively and collaborate with the interdisciplinary team * Demonstrate knowledge and skill in addressing age specific needs of patients served, (all age groups-birth and above) * Assure performance of behaviors that meet the requirements of the UNMC culture including: demonstrates behavior that fosters a positive team environment, demonstrates behaviors that promote diversity, applies continuous quality improvement principles, seeks the customers requirements and strives to meet them, and designs personal action plan for personal and professional development. * Maintains accountability for own actions in completing assigned tasks. Preferred Qualifications: Master's degree * Pediatric background and experience related to clinical trials coordination. * Certification/maintenance of certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) * Microsoft Outlook, experience with EPIC, REDcap and other research EDC * This position is key to the successful supervision of clinical research trials through monitoring patient care and treatment, protocol regulations, and providing education for patient, family and health care team. * Clinical research is based on the collection of information, requiring expert interpretation. Information must be accurately interpreted and recorded to ensure that research results are free of errors. Errors in the interpretation and recording of data may significantly alter research results. Therefore, data entry must be accurate and precise to positively impact patient care and research conclusions. * Clinical research is based on the collection of information, requiring expert interpretation. Information must be accurately interpreted and recorded to ensure that research results are free of errors. Errors in the interpretation and recording of data may significantly alter research results. Therefore, data entry must be accurate and precise to positively impact patient care and research conclusions. Compliance Requirements: * Physcial Exam * Drug Screen * Background Check * Child & Adult Sexual Abuse Registry Request and Check * Education Credentials Check * Hearing Exam * Visual/Color Examination * Fit Test (Respiratory Protection) * Immunizations Information at a Glance Apply now Req Id: 1560 Campus Name: University of Nebraska Medical Center (UNMC) Org Unit: CHRI Administration UNMC Job Location: Children's Main Campus - Omaha, NE 68198 Application Review Date: 10/30/25 Open Until Filled: Yes Advertised Salary: $60,800 - $91,200/annual Job Type: Full-Time Worksite Eligibility: Hybrid Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: ************* Special Instructions to Applicant: The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 10/28/25 Search Jobs

To coordinate clinical research for investigators in the Clinical Research Center. This individual will need to plan, organize, implement, document, and evaluate clinical research activities. This individual will be responsible for maintaining good clinical practices involving CRC research protocols. Additional Info About Us: To learn more about the University of Nebraska, visit the sites below. University of Nebraska Strategic Plan "Odyssey to Extraordinary" *********************************** Get to know Nebraska ***************************************** University of Nebraska Medical Center Campus *************************************** and *************************************** University of Nebraska Faculty & Staff Benefits ************************************** Required Qualifications: * Relevant coursework/specialized training in Nursing * 1 year nursing experience * Current Nebraska RN license or license eligible * Work schedule is 8:00am to 5:00pm Monday through Friday and requires working varied evenings/nights and weekends as needed. * Knowledge of current nursing procedures, techniques, and practices. * Good organizational skills. * Computer literacy imperative. * Ability to work effectively with other team members. * Good communication skills. * Able to do physical assessment as appropriate to protocol. * Ability to attend to accuracy and detail required. Ability to effectively contribute to team projects. * Demonstrate a positive attitude. Preferred Qualifications: * 1 year experience with other complex protocols (such as the ICU or special care units) or clinical research. * Microsoft Excel,Microsoft Word,Microsoft Outlook Compliance Requirements: * Physical Exam * Drug Screen * Background Check * Child & Adult Sexual Abuse Registry and Check * Education Credentials Check * Visual/Color Examination * Fit Test (Respiratory Protection) * Immunizations Information at a Glance Apply now Req Id: 1571 Campus Name: University of Nebraska Medical Center (UNMC) Org Unit: Clinical Research Center UNMC Job Location: Omaha, NE 68198 Application Review Date: 10/31/25 Open Until Filled: Yes Advertised Salary: $60,800 - $91,200/annual Job Type: Full-Time Worksite Eligibility: On-site Benefits Eligible: Yes Apply now For questions or accommodations related to this position contact: ************* Special Instructions to Applicant: The University of Nebraska does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. Posting Start Date: 10/27/25 Search Jobs