Clinical research associate jobs in Janesville, WI - 21 jobs

, 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.

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

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

**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.

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_

Description: Work Schedule: This is a 100% FTE position scheduled to typically work Monday through Friday, day shift hours. Hours may vary based on the operational needs of the department. This is primarily a remote position with occasional in person meetings. Be part of something remarkable! Join a team of remarkable staff in Clinical Research at UW Health, where experts seek better ways to prevent, diagnose and treat diseases and patients are often among the first in the world with access to promising new treatments. We are seeking a Registered Nurse - Clinical Research Program Specialist: Assist with proper integration of research in the electronic health record (EHR) and research-related EHR build to ensure clinical workflows, including proper medication and other clinical ordering processes are supported, ensuring patient-centric recruitment strategies are implemented and focusing on the safety of our research patients at UW Health. Collaborate with principal investigators, study specialists and other study team members, in addition to the Information Services staff, Clinical Research Unit (CRU) staff, Pharmaceutical Research Center (PRC) staff, and the physicians, nurses, and pharmacists who interact with research participants in the clinical setting at UW Health. Serve as a liaison between the clinical, research, and informatics staff, understanding all three realms and the goal of protocol fidelity and research patient/subject safety. At UW Health, you will have: An excellent benefits package, including health and dental insurance, paid time off, retirement plans, two-week paid parental leave and adoption assistance. Options for a variety of schedules and shifts that offer flexibility and allow for work-life balance. Access to great resources through the UW Health Employee Wellbeing Department that supports your emotional, financial, and physical well-being. Acuity based staffing ratios for optimal safety. A strong shared governance structure which assures every nurse has a voice. A place where nursing excellence is recognized and celebrated in our inpatient and outpatient settings through several award programs. Tuition benefits eligibility - UW Health invests in your professional growth as a nurse by helping pay for coursework associated with career advancement. The opportunity to earn a referral bonus for referring friends, former colleagues or others to apply for open, posted positions. Qualifications Bachelor's Degree In Nursing Required Master's Degree In Nursing or related field Preferred Work Experience 2 years Of clinical patient care experience Required 2 years Of clinical research related experience Preferred 2 years Of informatics experience Preferred Formal informatics training Preferred Experience in an academic medical center Preferred Project management experience Preferred Licenses & Certifications Licensed as a Registered Nurse (RN) in the State of WI or holds a license issued by a jurisdiction that has adopted the nurse licensure compact Required Our Commitment to Social Impact and BelongingUW Health is committed to fostering a workplace that creates belonging for everyone and is an Equal Employment Opportunity (EEO) employer. Our respect for people shines through patient care interactions and our daily work practices as we work to embrace the knowledge, unique perspectives and qualities each employee and faculty member brings to work each day. It is the policy of UW Health to provide equal opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. UW Health Administrative Facilities - UW Health has administrative locations throughout Madison and beyond where thousands of employees provide vital support to our clinical areas. These locations are home to departments such as Access Services, Compliance, Human Resources, Information Services, Patient Medical Records, Payroll and many others. Job DescriptionUW Hospital and Clinics benefits

Full-time Description The Research Administrator provides high-level strategic coordination and administrative leadership for the Coon Laboratory in collaboration with the Metabolism Theme at the Morgridge Institute. This role will provide support to the Metabolism Theme and associated research groups as needed. This position manages day-to-day laboratory activities for the Coon group, oversees comprehensive research budgets, and facilitates collaborative research to advance the group's mission. This role requires a highly organized, proactive professional capable of working independently while maintaining effective relationships across UW-Madison, the Morgridge Institute for Research, and external partners. The Research Administrator uses strong judgment, initiative, and creativity to support a complex scientific operation. Primary Responsibilities · Research Management and Administration: o Manage administrative and operational activities using UW-Madison and Morgridge Institute systems and policies for the Coon laboratory and metabolism theme as needed. o Prepare and coordinate scientific and technical proposals for Coon laboratory, including administrative, budgetary, research, educational, and outreach components. o Interpret and communicate federal, state, and university grant compliance requirements; ensure adherence to all applicable regulations. o Develop, manage, and implement research budgets in compliance with institutional and sponsor guidelines. o Conduct monthly post-award reviews with the PI to ensure appropriate spending and compliance. o Work with UW and Morgridge accounting teams on award closeouts. o Oversee preparation and submission of annual progress reports. o Execute and oversee financial transactions-including expense reports, travel reimbursements, purchase orders, and invoice payments-and support resolution of administrative issues. · Laboratory & Operational Support: o Maintain capital equipment inventory for the research laboratory, support annual audits. o Procure laboratory equipment and supplies and coordinate routine equipment calibration, maintenance, and repairs for laboratory. o Develop and maintain a comprehensive reference database tracking publications, collaborations, awards, patents, and trainee outcomes. Additionally, help support the public access compliance of papers that require it. o Update and maintain center websites and social media platforms to ensure a professional and consistent public presence. o Ensure biosafety protocols are updated; track and ensure completion of all required safety training for laboratory personnel. o Oversee compliance with regulations related to biohazards, laboratory safety, waste disposal, and effort certification. o Submit MTAs, software agreements, and other research agreements for review through campus channels. o Administrate project archive where all research data are stored. o Onboard and offboard trainees including lab access, laboratory resources, and appointments. o Supervise students and volunteers engaged in non-scientific tasks in support of Coon laboratory operations. · Scheduling, Communication and Event Support o Plan and support logistics for advisory board meetings, workshops, consortium meetings, site visits, invited seminars, and other program events. o Act as liaison with on-campus and off-campus partners, facilities, and administrative units. o Assist with posting job openings, managing personnel appointments, and initiating changes in support staff or project personnel. · Other duties as assigned o Perform additional responsibilities as assigned to support the missions of Coon Laboratory, and metabolism theme. Requirements To successfully perform this role, an individual must be able to carry out each primary duty effectively. The qualifications and requirements listed below reflect the knowledge, skills, and abilities necessary for this position. Reasonable accommodation will be provided, as appropriate, to enable individuals with disabilities to perform the essential functions of the job. Education and Experience · Bachelor's degree in business, science, biotechnology, or a related field preferred. · Minimum of three years of administrative experience required. · Experience supporting day-to-day laboratory operations, including supply ordering, equipment maintenance, safety and biosafety oversight, record-keeping, and coordination with research staff. · Working knowledge of NIH and NSF policies governing research proposals, awards, and allowable expenditures. Knowledge, Skills and Abilities Required · Ability to work both independently and collaboratively in a dynamic research environment. · Professional and effective communication with individuals at all organizational levels. · Strong interpersonal skills, including exceptional oral and written communication abilities. · Excellent organizational and time-management skills. · Consistently demonstrates respect, integrity, and professionalism in decisions, communications, and actions. · Experience in pre-award and post-award research administration. · Proven ability to manage multiple projects simultaneously. · Proficiency in software and web-based applications, including Microsoft Office and Google Workspace. · Experience with website development and management of social media platforms. · Ability to interact effectively with individuals from diverse backgrounds and professional levels. Working Conditions and Physical Effort · Work is normally performed in an office setting · No or very limited physical effort is required · No or very limited exposure to physical risk

RN Clinical Research 40 hours per week The Clinical Research Nurse, under the guidance of the Principal Investigator (Pl) and Manager of Inpatient Nursing, ensures that the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Mercyhealth policies and procedures. This position is primarily responsible for the accurate completion of visit procedures, the nursing assessment and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. Responsibilities ESSENTIAL DUTIES AND RESPONSIBILITIES * Ensures compliance with each study's protocol by providing thorough review and documentation at each subject study visit * Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements * Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies Principle Investigator of findings/issues * Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment * Documents medical data in patient chart to capture protocol requirements * Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities * Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Mercyhealth databases * Supports the regulatory staff in the maintenance of regulatory documents in accordance with Mercyhealth SOP and applicable regulations * Interfaces with research participants, to support efforts to determine eligibility and consenting of study participants according to protocol * Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsors, monitors, Pl, and study participants * Ensures compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability * Disburses investigational drug and provides patient teaching regarding administration, as necessary * Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants * Participates with the Pl and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance * Other duties as assigned EDUCATION AND EXPERIENCE Required Associates Degree in Nursing Preferred Two years of clinical nursing experience in a hospital, clinic, or similar healthcare setting One year of clinical research experience One year Neurology nursing experience CERTIFICATION AND LICENSURE Required Licensed as a Registered Nurse in state of practice BLS Certification required within three months Preferred Nursing certification in Neurology Benefits Benefits include: Medical, Dental, Vision Life & Disability Insurance FSA/HSA Options Generous PTO Parental & Caregiver Leave Career Advancement Educational Assistance Wellbeing Programs Employee Discounts On-Demand Pay Financial Education

The Clinical Research Coordinator I oversee the conduct of clinical research investigations involving patients and community participants. Employee possesses an in-depth knowledge of federal regulations and guidance for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation. This position is located in Oconomowoc, WI. Assist in research planning, design and implementation including the development of standard operating procedures (SOPs), research forms and source documentation tools. Coordinate and participate in recruitment activities, subject enrollment, and follow-up procedures for multiple research protocols. Using proper laboratory and phlebotomy technique, ensure appropriate specimen collection, processing, and shipping as required per protocol. Maintain compliance with GCP guidelines for the conduct of research including study documentation and subject confidentiality/privacy. Prepare for, schedule, and participate in meetings with research sponsors, contract research organizations (CROs), government and other regulatory entities. Obtain and manage regulatory and Institutional Review Board (IRB) approvals and communications. Demonstrate an understanding of research regulatory compliance and participate in educational opportunities to increase research involvement and awareness of regulations, policies, and study activities. Collaborate with Research Center staff and other departments in order to accomplish research goals. Promote a team atmosphere by treating individuals with respect and honesty and by using direct communication and active listening skills. Be open to change and actively support change; Be open to others' ideas and points of view; Adhere to following policies and procedures for Rogers. Promote department goals as well as the mission of Rogers. Demonstrate measurable goal achievement; Adhere to department policies and procedures; Resolve individual issues with peers in a positive, solutions focused manner; Include requirements and guidelines from external agencies (i.e., Joint Commission, State of Wisconsin). Participate in Roger's committees, performance improvement team meetings, and team projects, as directed. A. Demonstrate punctuality and preparedness. Demonstrate organizational skills that promote timely response to all inquiries and to task completion. Communicate with all individuals in a positive and professional manner. Attempt to resolve individual issues with peers in a positive, calm manner, with a focus on solution. Communicate concerns and provide solutions for same. Project a professional image by wearing appropriate, professional attire. Additional Job Description: This position is located in Oconomowoc, WI. Education/Training Requirements: Associates degree in behavioral science, nursing or a related field required. Bachelor's Degree preferred. [LPN or CNA and minimum (3) three years of research experience may be considered in lieu of advanced degree requirements.] Minimum of three (3) years of work experience in a clinical or research setting. Competence in research methodologies and knowledge of clinical protocols; Analytical skills and the ability to resolve technical or research problems and issues; experience working with IRBs. Preferred phlebotomy certificate and ability to perform EKGs and obtain vital signs. Proficient with various computer software programs, hardware devices, and ability to learn laboratory equipment. Completion of applicable research training certification through CITI or comparable program. May be completed within first 30 days of employment. American Heart Association Healthcare Provider CPR certification or American Red Cross Professional Rescue is preferred and may be required within thirty (30) days of hire. Formal training in management of the aggressive patient is required within sixty (60) days of date of hire. Annual re-certification is required. With a career at Rogers, you can look forward to a Total Rewards package of benefits, including: Health, dental, and vision insurance coverage for you and your family 401(k) retirement plan Employee share program Life/disability insurance Flex spending accounts Tuition reimbursement Health and wellness program Employee assistance program (EAP) Through UnitedHealthcare, UMR and HealthSCOPE Benefits creates and publishes the Machine-Readable Files on behalf of Rogers Behavioral Health. To link to the Machine-Readable Files, please visit Transparency in Coverage (uhc.com)

Posting Date 12/01/20251305 Woodman Rd, Janesville, Wisconsin, 53545, United States of America DaVita is hiring a Clinical Coordinator to lead outpatient dialysis care for patients with end-stage renal disease. In this role, you'll oversee treatment, guide clinical staff, and ensure the highest standards of care and safety. Key Responsibilities: Coordinate patient care plans and monitor outcomes Supervise clinical staff, including PCTs Ensure safe, compassionate dialysis delivery Build long-term relationships with patients and families Work in a fast-paced, team-oriented environment Requirements: Current RN license and CPR certification 18+ months RN experience, including 6+ months dialysis Charge RN readiness approval required ADN required; BSN preferred ICU, ER, or Med/Surg experience preferred CNN/CDN certification a plus Basic computer skills (MS Word, Outlook) Flexible schedule, including weekends and holidays What We Offer: Medical, dental, vision, 401(k) match PTO and PTO cash-out Paid training and development Family and mental health support (Headspace, EAP, child/elder care) Ready to lead and make a difference? Apply now. #LI-LM1 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

Join our team as a Research Nurse where you will play a pivotal role in conducting clinical trials, ensuring the safety and welfare of study participants. Responsibilities * Enroll patients into clinical trials, including the Informed Consent process by educating, explaining, and informing participants of study procedures. * Utilize nursing skills, knowledge, and clinical judgment to provide high-quality care for trial participants. * Use nursing assessment skills to observe participants' general well-being and identify potential adverse events. * Document adverse events and take appropriate action as needed. * Perform study-related activities such as cannulation, telemetry, holters, vital signs, ECGs, and venipuncture. * Collect and process biological samples according to the protocol and Standard Operating Procedures. * Record data in a timely, error-free manner according to the protocol and Standard Operating Procedures. * Transcribe source data onto the Case Report Form. Essential Skills * Active Registered Nurse (RN) license in Wisconsin, in good standing. * Associates Degree or Bachelors Degree in Nursing (ASN or BSN). * 0-3 years of nursing experience in a patient-facing setting. * Alternatively, a Licensed Practical Nurse (LPN) with 0-3 years of nursing experience, active and in good standing in Wisconsin. Additional Skills & Qualifications * Previous experience with clinical research is preferred. * CPR and ACLS certifications. Work Environment The position is based at the Phase I Clinical Research Unit in Madison, WI. The work environment is dynamic, with a focus on clinical research and the opportunity for professional growth. The organization provides extensive training in clinical research and study-specific protocols. Job Type & Location This is a Contract to Hire position based out of MADISON, WI. Pay and Benefits The pay range for this position is $30.00 - $38.00/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 MADISON,WI. Application Deadline This position is anticipated to close on Jan 23, 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.

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. Want to join a fun, hard-working, collaborative team? Come join the Pediatric Clinical Research Coordination team! The UW Pediatric Clinical Research Coordination team supports clinical research across multiple divisions in the Department of Pediatrics. This is a unique opportunity to contribute to research aimed at prevention, detection, and treatment of disease in children. This position will assist with coordinating a variety of clinical research studies by performing various tasks and activities. These tasks include, but are not limited to, recruiting, screening, and enrolling study participants and families, as well as ensuring study participants and families follow the research study protocol. Our team of clinical research coordinators and research nurses apply expertise, knowledge, and skills to a broad range of clinical studies, navigate resources, identify issues requiring escalation, and contribute to the development of new team and unit processes, procedures, and tools. The Research Nurse will work in collaboration with pediatric faculty, nurses and staff to coordinate clinical research studies for the Department of Pediatrics, ranging from industry-partnered to investigator-initiated clinical trials. This position is full or part-time, 90-100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. Some work may need to be performed outside of standard business hours. However, most work is expected to occur during standard business hours. Key Job Responsibilities: May provide expertise, training, and guidance to the community, peers, and/or students Supervises the day-to-day activities of research work unit Serves as main point of contact and liaison to project participants, investigators, research sponsors, and the research team delivering study information in accordance with established research project standards and protocols Secures and schedules logistics for clinical research projects according to the research plan Assists in the recruitment and screening of subjects for clinical studies by conducting physical health assessments Collects, verifies, and enters data into database and analyzes clinical information data Provides professional nursing care to patients according to established protocols Serves a primary point of contact for emergent study participant situations related to adverse effects or complications of the study Provides appropriate treatment plan direction and information to study participants Department: School of Medicine and Public Health, Department of Pediatrics, Administration - Clinical Research The Department of Pediatrics at the University of Wisconsin School of Medicine and Public Health is a vibrant academic department comprising more than 230 faculty members in 16 subspecialty divisions. The department promotes and enhances the health of children through outstanding clinical care, exemplary education of pediatric trainees, performance of cutting-edge research, and vigorous advocacy. Our faculty and research staff enjoy a robust infrastructure of services as well as the opportunity to contribute to our world-class research portfolio - since 2015 the department has ranked among the Top 20 pediatrics departments receiving NIH funding, according to Blue Ridge Institute for Medical Research. To provide remarkable health care for everyone in our community, we are committed to fostering a diverse, equitable, and inclusive environment in all aspects of our work. To learn more about the department's work and accomplishments, please visit: ********************************* Compensation: The starting salary for the position is $68,000 annually; but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage. SMPH Faculty /Academic Staff Benefits Flyer 2026 Required Qualifications: Minimum 1 year of experience in a clinical setting Registered Nurse (RN) License required by start date of position Preferred Qualifications: 2 or more years of nursing experience Experience working in a clinical research role Experience working with the pediatric population Experience working in a healthcare setting Experience working with research data collection and/or sample processing Experience utilizing a variety of platforms including Health Link or other electronic medical record, Microsoft Office Suite, REDCap, OnCore, and Google Drive Clinical Research Certification or Clinical Research Nurse Certification Education: Bachelor's Degree required; Degree in nursing required Registered Nurse (RN) State Licensure And/Or Compact State Licensure Required Candidate is required to have or be eligible for WI Registered Nurse licensure by start date How to Apply: For the best experience completing your application, we recommend using Chrome or Firefox as your web browser. To apply for this position, select either “I am a current employee” or “I am not a current employee” under Apply Now. You will then be prompted to upload your application materials. Important: The application has only one attachment field. Upload all required documents in that field, either as a single combined file or as multiple files in the same upload area. Upload required documents: • Cover letter • Resume Your cover letter should address how your training and experience align with the required and preferred qualifications listed above. Application reviewers will rely on these written materials to determine which applicants move forward in the process. References will be requested from final candidates. All applicants will be notified once the search concludes and a candidate is selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work. The department will not be able to support a request for a J-1 waiver. If you choose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees. Contact Information: Hope Jende, *******************, ************ Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information. Institutional Statement on Diversity: Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. The University of Wisconsin-Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website. To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. Job Category: Academic Staff Employment Type: Regular Job Profile: Research Nurse Want to join a fun, hard-working, collaborative team? Come join the Pediatric Clinical Research Coordination team! The UW Pediatric Clinical Research Coordination team supports clinical research across multiple divisions in the Department of Pediatrics. This is a unique opportunity to contribute to research aimed at prevention, detection, and treatment of disease in children. This position will assist with coordinating a variety of clinical research studies by performing various tasks and activities. These tasks include, but are not limited to, recruiting, screening, and enrolling study participants and families, as well as ensuring study participants and families follow the research study protocol. Our team of clinical research coordinators and research nurses apply expertise, knowledge, and skills to a broad range of clinical studies, navigate resources, identify issues requiring escalation, and contribute to the development of new team and unit processes, procedures, and tools. The Research Nurse will work in collaboration with pediatric faculty, nurses and staff to coordinate clinical research studies for the Department of Pediatrics, ranging from industry-partnered to investigator-initiated clinical trials. * This position is full or part-time, 90-100% * This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. * This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. * Some work may need to be performed outside of standard business hours. However, most work is expected to occur during standard business hours. Key Job Responsibilities: * May provide expertise, training, and guidance to the community, peers, and/or students * Supervises the day-to-day activities of research work unit * Serves as main point of contact and liaison to project participants, investigators, research sponsors, and the research team delivering study information in accordance with established research project standards and protocols * Secures and schedules logistics for clinical research projects according to the research plan * Assists in the recruitment and screening of subjects for clinical studies by conducting physical health assessments * Collects, verifies, and enters data into database and analyzes clinical information data * Provides professional nursing care to patients according to established protocols * Serves a primary point of contact for emergent study participant situations related to adverse effects or complications of the study * Provides appropriate treatment plan direction and information to study participants Department: School of Medicine and Public Health, Department of Pediatrics, Administration - Clinical Research The Department of Pediatrics at the University of Wisconsin School of Medicine and Public Health is a vibrant academic department comprising more than 230 faculty members in 16 subspecialty divisions. The department promotes and enhances the health of children through outstanding clinical care, exemplary education of pediatric trainees, performance of cutting-edge research, and vigorous advocacy. Our faculty and research staff enjoy a robust infrastructure of services as well as the opportunity to contribute to our world-class research portfolio - since 2015 the department has ranked among the Top 20 pediatrics departments receiving NIH funding, according to Blue Ridge Institute for Medical Research. To provide remarkable health care for everyone in our community, we are committed to fostering a diverse, equitable, and inclusive environment in all aspects of our work. To learn more about the department's work and accomplishments, please visit: ********************************* Compensation: The starting salary for the position is $68,000 annually; but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage. * SMPH Faculty /Academic Staff Benefits Flyer 2026 Required Qualifications: * Minimum 1 year of experience in a clinical setting * Registered Nurse (RN) License required by start date of position Preferred Qualifications: * 2 or more years of nursing experience * Experience working in a clinical research role * Experience working with the pediatric population * Experience working in a healthcare setting * Experience working with research data collection and/or sample processing * Experience utilizing a variety of platforms including Health Link or other electronic medical record, Microsoft Office Suite, REDCap, OnCore, and Google Drive * Clinical Research Certification or Clinical Research Nurse Certification Education: * Bachelor's Degree required; Degree in nursing required * Registered Nurse (RN) State Licensure And/Or Compact State Licensure Required * Candidate is required to have or be eligible for WI Registered Nurse licensure by start date How to Apply: For the best experience completing your application, we recommend using Chrome or Firefox as your web browser. To apply for this position, select either "I am a current employee" or "I am not a current employee" under Apply Now. You will then be prompted to upload your application materials. Important: The application has only one attachment field. Upload all required documents in that field, either as a single combined file or as multiple files in the same upload area. Upload required documents: * Cover letter * Resume Your cover letter should address how your training and experience align with the required and preferred qualifications listed above. Application reviewers will rely on these written materials to determine which applicants move forward in the process. References will be requested from final candidates. All applicants will be notified once the search concludes and a candidate is selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work. The department will not be able to support a request for a J-1 waiver. If you choose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees. Contact Information: Hope Jende, *******************, ************ Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information. Institutional Statement on Diversity: Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. The University of Wisconsin-Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website. To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Supports assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Diligently manages significant matters pertaining to assigned projects to "Provide the industry's leading customer experience" supporting PCI Clinical Service's long term growth and success. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting. * Leads weekly customer calls and Clinical Project Team meetings in absence of Project Manager or as designated. * Creates notes for weekly customer teleconference calls and internal Clinical Project Team meetings. * Creates project specific documentation including packaging/labeling protocols, variable data forms, sample shipment request forms, monthly finished goods inventories, logistics instructions, returns accountability worksheet, monthly distribution reports. * Manages timing of internal process to ensure timely receipt and release of bulk, project packaging components, and shipping supplies. * Communicates with customers and vendors to resolve missing or erroneous certs and documentation related to receiving and QC release of bulk, packaging components, and shipping supplies. * Monitors and updates Clinical Project Coordinator with production needs for project. * Creates project specific bills of material. * Works closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests. * Identifies lot specific drug product and components for production job staging. * Works with customers and sites to resolve discrepancies on end of study returns. * Creates Destruction Authorization Forms and forwards to customer for destruction approval of returns, remaining finished goods, and customer owned inventories. * Assists in monthly packaging and distribution invoices processing. * Records data in project specific metrics. * Resolves shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites. * Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects. Acts as back-up Project Manager contact for internal communications and trouble-shooting. * Accountable for assigned project tasks using appropriate project planning tools. * Host and manage customer visits at PCI as necessary. * Support cross-functional leadership on improvement opportunities and strategic initiatives. * Participate in meetings and reporting with Project Management, Operations, and Quality management. * Training and on-boarding of new employees within same role as requested. * Maintains and updates project plans and timelines as requested. * Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects. * This position may require overtime and/or weekend work. * Attendance to work is an essential function of this position. * Performs job duties as assigned by Manager/Supervisor. QUALIFICATIONS: Required: * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to work independently and/or as part of a team. * Ability to display excellent time management skills. * Ability to display a willingness to make decisions. * Ability to adapt to changing work environments. The base salary hiring range for this position is ($56,720- $64,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). The APM role begins 100% onsite for first 90 days. "Upon successful completion of key milestone tasks, a review of remote flexibility will be discussed among APM, PM and Sr. Mgr to determine eligibility for a hybrid work model." #LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Supports assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Diligently manages significant matters pertaining to assigned projects to “Provide the industry's leading customer experience” supporting PCI Clinical Service's long term growth and success. ESSENTIAL DUTIES AND RESPONSIBILITIES: Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting. Leads weekly customer calls and Clinical Project Team meetings in absence of Project Manager or as designated. Creates notes for weekly customer teleconference calls and internal Clinical Project Team meetings. Creates project specific documentation including packaging/labeling protocols, variable data forms, sample shipment request forms, monthly finished goods inventories, logistics instructions, returns accountability worksheet, monthly distribution reports. Manages timing of internal process to ensure timely receipt and release of bulk, project packaging components, and shipping supplies. Communicates with customers and vendors to resolve missing or erroneous certs and documentation related to receiving and QC release of bulk, packaging components, and shipping supplies. Monitors and updates Clinical Project Coordinator with production needs for project. Creates project specific bills of material. Works closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests. Identifies lot specific drug product and components for production job staging. Works with customers and sites to resolve discrepancies on end of study returns. Creates Destruction Authorization Forms and forwards to customer for destruction approval of returns, remaining finished goods, and customer owned inventories. Assists in monthly packaging and distribution invoices processing. Records data in project specific metrics. Resolves shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites. Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects. Acts as back-up Project Manager contact for internal communications and trouble-shooting. Accountable for assigned project tasks using appropriate project planning tools. Host and manage customer visits at PCI as necessary. Support cross-functional leadership on improvement opportunities and strategic initiatives. Participate in meetings and reporting with Project Management, Operations, and Quality management. Training and on-boarding of new employees within same role as requested. Maintains and updates project plans and timelines as requested. Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects. This position may require overtime and/or weekend work. Attendance to work is an essential function of this position. Performs job duties as assigned by Manager/Supervisor. QUALIFICATIONS: Required: Associate's Degree in a related field and/or 1-3 years related experience and/or training. Basic Mathematical Skills Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: Ability to work independently and/or as part of a team. Ability to display excellent time management skills. Ability to display a willingness to make decisions. Ability to adapt to changing work environments. The base salary hiring range for this position is ($56,720- $64,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). The APM role begins 100% onsite for first 90 days. "Upon successful completion of key milestone tasks, a review of remote flexibility will be discussed among APM, PM and Sr. Mgr to determine eligibility for a hybrid work model." #LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

The mission of the Wisconsin Association of Free & Charitable Clinics (WAFCC) is to support, strengthen, and advocate for the uniqueness of the Wisconsin free and charitable clinics, the patients they serve, and the communities and organizations with whom they partner. The VISTA will serve at Perry Family Free Clinic whose mission is to ensure that black men and boys living in under-represented communities, who bear the heaviest burden of disease and poor health status, could have the opportunity to live fuller, healthier lives. The VISTA will engage in education and outreach, community engagement, resource development, training programs, and coordinating sexual reproductive health services. Further help on this page can be found by clicking here. Member Duties : The 2026 VISTA Associate at Perry Family Free Clinic will support the Clinic's Sexual Education Project through capacity-building activities, including the development of curricula and learning materials, creation of planning and facilitation guides for staff- or partner-led youth forums, and research and documentation of resources that promote healthy living and positive life choices. The VISTA will build organizational and community capacity by developing educational materials, outreach strategies, engagement frameworks, resource development tools, and coordination systems that support sustainable sexual and reproductive health initiatives. All activities will be indirect and capacity-building in nature and will not include direct service delivery to clients. Program Benefits : Training , Choice of Education Award or End of Service Stipend , Education award upon successful completion of service , Living Allowance , Relocation Allowance , Childcare assistance if eligible , Health Coverage* . Terms : Car recommended , Permits working at another job during off hours , Permits attendance at school during off hours . Service Areas : Community and Economic Development , Housing , Public Health AmeriCorps , Health , Children/Youth , Community Outreach , Education , Homelessness . Skills : Community Organization , Education , Youth Development , Fund raising/Grant Writing , Writing/Editing , General Skills , Leadership , Social Services , Communications , Teaching/Tutoring , Public Health , Conflict Resolution , Non-Profit Management .

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.

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_

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Supports assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Diligently manages significant matters pertaining to assigned projects to "Provide the industry's leading customer experience" supporting PCI Clinical Service's long term growth and success. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting. + Leads weekly customer calls and Clinical Project Team meetings in absence of Project Manager or as designated. + Creates notes for weekly customer teleconference calls and internal Clinical Project Team meetings. + Creates project specific documentation including packaging/labeling protocols, variable data forms, sample shipment request forms, monthly finished goods inventories, logistics instructions, returns accountability worksheet, monthly distribution reports. + Manages timing of internal process to ensure timely receipt and release of bulk, project packaging components, and shipping supplies. + Communicates with customers and vendors to resolve missing or erroneous certs and documentation related to receiving and QC release of bulk, packaging components, and shipping supplies. + Monitors and updates Clinical Project Coordinator with production needs for project. + Creates project specific bills of material. + Works closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests. + Identifies lot specific drug product and components for production job staging. + Works with customers and sites to resolve discrepancies on end of study returns. + Creates Destruction Authorization Forms and forwards to customer for destruction approval of returns, remaining finished goods, and customer owned inventories. + Assists in monthly packaging and distribution invoices processing. + Records data in project specific metrics. + Resolves shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites. + Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects. Acts as back-up Project Manager contact for internal communications and trouble-shooting. + Accountable for assigned project tasks using appropriate project planning tools. + Host and manage customer visits at PCI as necessary. + Support cross-functional leadership on improvement opportunities and strategic initiatives. + Participate in meetings and reporting with Project Management, Operations, and Quality management. + Training and on-boarding of new employees within same role as requested. + Maintains and updates project plans and timelines as requested. + Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects. + This position may require overtime and/or weekend work. + Attendance to work is an essential function of this position. + Performs job duties as assigned by Manager/Supervisor. **QUALIFICATIONS:** **Required:** + Associate's Degree in a related field and/or 1-3 years related experience and/or training. + Basic Mathematical Skills + Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. + Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. + Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. **Preferred:** + Ability to work independently and/or as part of a team. + Ability to display excellent time management skills. + Ability to display a willingness to make decisions. + Ability to adapt to changing work environments. The base salary hiring range for this position is ($56,720- $64,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). The APM role begins 100% onsite for first 90 days. "Upon successful completion of key milestone tasks, a review of remote flexibility will be discussed among APM, PM and Sr. Mgr to determine eligibility for a hybrid work model." \#LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled