Clinical research associate jobs in Des Moines, IA - 118 jobs

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. **Essential Functions and Other Job Information:** **Essential Functions** + Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. + Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. + Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. + Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. + Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). + Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. + Responds to company, client and applicable regulatory requirements/audits/inspections. + Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. + Contributes to other project work and initiatives for process improvement, as required. **Qualifications:** **Education and Experience:** Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as traveling clinical research associate). Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. **Knowledge, Skills and Abilities:** + Effective clinical monitoring skills + Demonstrated understanding of medical/therapeutic area knowledge and medical terminology + Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents + Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving + Ability to manages Risk Based Monitoring concepts and processes + Effective oral and written communication skills, with the ability to communicate effectively with medical personnel + Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues + Effective interpersonal skills + Strong attention to detail + Effective organizational and time management skills + Ability to remain flexible and adaptable in a wide range of scenarios + Ability to work in a team or independently as required + Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software + Good English language and grammar skills + Good presentation skills **Compensation and Benefits** The salary range estimated for this position based in Illinois is $79,200.00-$136,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: + A choice of national medical and dental plans, and a national vision plan, including health incentive programs + Employee assistance and family support programs, including commuter benefits and tuition reimbursement + At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy + Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan + Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: ***************************************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

, 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.

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Research Scientist - Clinical Study Management The Research Scientist - Clinical Study Management position is responsible for the management of pivotal, regulated and non-pivotal studies at Elanco sites and Contract Research Organizations. You will work collaboratively to support experimental design and scientific interpretation of study results, and production of any materials for patents or publications. Your Responsibilities: Oversee Study Design and Execution: Lead the design and execution of clinical studies, including GLP, GCP, pivotal and non-pivotal studies, acting as Study Director for GLP safety studies and Study Investigator for clinical studies, ensuring overall conduct and scientific integrity. Ensure Comprehensive Regulatory Compliance: Maintain rigorous compliance with Good Laboratory Practice (GLP) - 21 CFR Part 58, Good Clinical Practices (GCP), and all applicable internal and external guidelines (e.g., SOPs, HSE, Animal Welfare, IACUC approvals), including managing protocol excursions and corrective actions. Manage End-to-End Study Documentation: Drive the development and completion of study protocols and final reports, support the creation and maintenance of all study-related SOPs, templates, and forms, and ensure the accurate interpretation, analysis, documentation, and secure archiving of all raw data and specimens. Facilitate Cross-Functional Coordination & Communication: Coordinate with study staff for protocol training and execution preparation, organize IVP supply management, and ensure continuous, clear communication between the Study Director, Sponsor Representative, Investigator, Clinical team, QA, and Study Monitor. Contribute to Scientific Advancement & IP: Support the generation of potential patents and publications based on study findings, leveraging study results to advance scientific knowledge and intellectual property within Elanco. What You Need to Succeed (minimum qualifications): MS with 4+ years, BS with 7+ years of experience, or Doctorate level education (e.g., PhD, DVM, MD) with 2+ years in a relevant industry. Experience managing clinical study initiation, execution, and completion and thorough understanding in coordinating various clinical functional groups including regulatory, clinical laboratory, clinical execution, veterinary services, and animal care personnel. Background with both USDA and EU Regulatory guidelines preferred. What will give you a competitive edge (preferred qualifications): Experience with clinical study management in the Animal Health industry is highly desired. Strong organizational and time management skills. Advanced ability to define problems, collect data, establish facts, and draw valid conclusions. Experience with biological vaccines, small molecules, and large molecules. Experience with or willing to gain experience with Pain and Dermatology models. Additional Information: Travel: Up to 10% Location: Fort Dodge, Iowa Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Clinical Research Associate (CRA) conducts in-house and external monitoring to verify that reported data collected in Clinical Lab Studies and Field Trials are accurate, complete, and verifiable from source documents and to ensure that the studies are conducted in compliance with the current approved protocol, GCP/ VICH requirements, FDA/CVM Regulations, and BI SOPs. The incumbent is responsible for ensuring quality of study protocols, raw data, and reports to support registrations and other claims related to veterinary products. The CRA performs these duties for on-site and off-site (national and global) clinical studies and trials for all animal species. Duties for this role include interaction with CROs/Investigators, monitoring of study status, quality control and integrity of data, management of study data and performing procedures in compliance to GxP and relevant regulatory guidelines. The CRA also circulates documents for approval, drafts study documents and reports, assists with study in-life phase, designs and implements study related processes, and is responsible for the closure of studies including preparation of archiving. **Duties & Responsibilities** + Makes certain that all documents related to in-house, CRO, and field studies are accurate as to drug dosages, drug accountability, numerical calculations, concurrent medications, clinical signs when compared to clinic records, adverse events, clinical observations, and analytical results. + Documents to be audited include, but not limited to, study notebooks, study reports, protocols, study checklists, and analytical data. + Identification of qualified CROs/FT Investigators. + Conduct Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff. + Conduct pre-study and ongoing monitoring visits in compliance with Guidelines for all study/trial sites. + Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, providing status reports in progression of the animal or report writing phases of the study. + Verifies both individual subject and overall drug accountability. + Identifies problems with enrollment and mitigations to resolve the issues. + Collaborates with the Clinical Scientist and Study/Trial team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc. + Assists Scientists in planning and implementation of investigator meetings and/or webinars. + Monitors Adverse Event (AE) reporting and request primary and follow-up information. + Provides information to pharmacovigilance and RA according to the study protocol and SOPs. + Ensures availability of all final study documentation for audits/inspections (internal compliance or CVM). + Prepares protocols, data, reports, and other documents for submission to regulatory agencies. + Collaborates closely with Regulatory Affairs to align on document organization. Responsible for: + Appropriate quality of study protocols, raw data and reports. + All study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents. + Protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations. + Deviations are identified and reported to the appropriate Study personnel. + Quality control audits of data entry and statistical reports. **Requirements** + Good verbal and written communication skills (correspondence, protocols, reports, etc.) + Good interpersonal skills. + Collaborative team player. + Possesses a customer service orientation, delivering results and executing in a fast and focused manner. + Solid organizational skills with a quality orientation. + Strives for business process excellence. + Effective time management. + High degree of attention to detail. + Ability to find errors or inconsistencies others may miss. + Exhibits integrity and trust. + Willingness to travel up to 60% of time. + English: Fluent (read, write and speak). CRA: + Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.) with one (1) year of experience focusing on clinical studies or two-plus (2+) years' experience in Human Pharma or Animal Health Research areas. SR CRA: + Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred. + Minimum of 3-5 years' experience as a CRA/Monitor or similar role **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **GI_US925** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

**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_

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Scheduled Hours 40 Our clinical research program includes dozens of studies sponsored through the NIH, Department of Defense, National MS Society, and various pharmaceutical companies. Our comprehensive program studies the most relevant and greatest unmet needs. This includes basic lab research, biomarkers, imaging, clinical repositories, clinical trials, and international consortiums. Key research includes causes of MS, diagnosis, prognostication, therapies, imaging, clinical outcomes, and socioeconomic factors. This position focuses on industry-sponsored clinical trials. Dr. Rob Naismith, Professor of Neurology, directs a clinical research team of over 10 research coordinators and a research nurse. MS faculty include Drs. Anne Cross, Rob Naismith, Greg Wu, Salim Chahin, Matt Brier, and Kimystian (Mysti) Harrison, all who are involved in both clinical care and research. The MS clinical staff includes a nurse practitioner, two nurses, a medical assistant, administrative coordinator, and pre-authorization specialist. Job Description Primary Duties & Responsibilities: * Assists clinical research coordinators with management of clinical trials, including: screening, enrolling, preparing informed consent packets, extracting data accurately from source documents and reporting in various data entry systems within protocol specified deadlines, routinely ensuring timely completion of all protocol requirements. * Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. * Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. * Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. * Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: * Normal office environment. Physical Effort: * Typically sitting at desk or table. * Repetitive wrist, hand or finger movement. Equipment: * Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time. Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications: * Basic Life Support certification must be obtained within one month of hire date * Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications: * Previous experience conducting informed consent discussions with patients participating in clinical trials, ensuring they understood the study's purpose, procedures, risks, and benefits. Preferred Qualifications Education: Associate degree Certifications: No additional certification unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Data Collection Methods, Detail-Oriented, Diagnostic Testing, Interpersonal Communication, Oral Communications, Organizing, Screenings, Written Communication Grade C07-H Salary Range $19.21 - $28.85 / Hourly The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits Statement Personal * Up to 22 days of vacation, 10 recognized holidays, and sick time. * Competitive health insurance packages with priority appointments and lower copays/coinsurance. * Take advantage of our free Metro transit U-Pass for eligible employees. * WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness * Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family * We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. * WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO Statement Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Patient Coordination Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Prescreen study candidates Obtain informed consent per Care Access Research SOP . Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Assist in the creation and review of source documents. Patient Recruitment Assist with planning and creation of appropriate recruitment materials. Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct Communicate clearly verbally and in writing Attend Investigator meetings as required Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required Ability to understand and follow institutional SOPs. Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Licenses: California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in Springfield, Missouri Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of travel required: Regional (within 100 miles) Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Walking - 20% Standing - 20% Sitting - 20% Lifting - 20% Up to 25lbs Over 25lbs Overhead Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Medical Assistant/Clinical Research Coordinator Schedule Onsite Monday-Friday 8 am-5 pm Assists the CRCs and PIs with all administrative tasks related to clinical research trials Phlebotomy and specimen processing Conducts telephone or in-person interviews with participants including screening for eligibility Performs follow-up for appointments and manages scheduling of appointments (by telephone, e-mail, and/or mail) with study participants Prepares,mails and processes questionnaires and other study correspondence Assistin tracking study participants using MS Excel Keeps accurate and detailed records and files of work Reviews,edits, cleans, and enters participant data into a database Assists with regulatory management May assist with literature reviews for proposal submissions and manuscriptpreparation Bookkeeping related to study budgets (ordering supplies, requesting checks for payment& participant incentives) Miscellaneous administrative tasks (typing labels, copying, faxing, meeting preparation,note-taking, transcribing audio files, etc.) Qualifications MUST have 1 year of Medical Assistant or Patient Care experience Customer service experience High School Diploma or General Education Development (GED) required MUST have experience with EHR/EMR systems MUST have experience with Microsoft Office Suite (Outlook, Excel, Word, etc.) Pay and Benefits The pay range for this position is $25.00 - $30.00/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 Ames,IA. Application Deadline This position is anticipated to close on May 9, 2025. 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.

Thanks for your interest in Children's Mercy! Do you envision finding a meaningful role with an inclusive and compassionate team? At Children's Mercy, we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference, which is why we have been recognized by U.S. News & World Report as a top pediatric hospital, for eleven consecutive years. Children's Mercy is in the heart of Kansas City - a metro abounding in cultural experiences, vibrant communities and thriving businesses. This is where our patients and families live, work and play. This is a community that has embraced our hospital and we strive to say thanks by giving back. As a leader in children's health, we engage in meaningful programs and partnerships throughout the region so that we can improve the lives of children beyond the walls of our hospital. Overview Participate in or lead day to day operations of clinical research studies conducted by principal investigator(s)primarily with the pediatric oncology group; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks. At Children's Mercy, we are committed to ensuring that everyone feels welcomed within our walls. A successful candidate for this position will join us as we strive to create a workplace that reflects the community we serve, as well as our core values of kindness, curiosity, inclusion, team and integrity. Additionally, it's important to us that we remain transparent with all potential job candidates. Because we value the safety of the patients and families we serve, as well as the Children's Mercy staff, we want to let you know that the seasonal influenza vaccine is a condition of employment for all employees in our organization. New employees must be willing to be vaccinated if found non-immune to measles, mumps, rubella (MMR) and chicken pox (varicella) and/or without evidence of tetanus, diphtheria, acellular pertussis (Tdap) vaccination since 2005. If you are selected for this position, you will be asked to supply your immunization records as proof of vaccination. If you and have any concerns about receiving these vaccines, medical and/or religious exemptions can be further discussed with Human Resources. Responsibilities Research Operations Regulatory Support Data Capture Management Staff Training/Research Education Financials/Fiscal Support Qualifications Master's Degree Health related field and 1-2 years experience or Bachelor's Degree Health related field and 3-5 years experience or Associate's Degree Health or science related field and 7 or more years experience One of the following: Certified Clinical Research Professional, Certified Clinical Research Coordinator, Certified Clinical Research Associate, Assoc of Clinical Research Professionals - Cert Professional required upon hire Employees must obtain Certified Clinical Research Professional or equivalent within 365 days Employees must obtain Certified Clinical Research Coordinator or equivalent within 365 days Employees must obtain Certified Clinical Research Associate or equivalent within 365 days Employees must obtain Assoc of Clinical Research Professionals - Cert Professional or equivalent within 365 days Benefits at Children's Mercy The benefits plans at Children's Mercy are one of many reasons we are recognized as one of the best places to work in Kansas City. Our plans are designed to meet the changing needs of our employees and their families. Learn more about Children's Mercy benefits. Starting Pay Our pay ranges are market competitive. The pay range for this job begins at $28.39/hr, but your offer will be determined based on your education and experience. EEO Employer/Disabled/Vet Children's Mercy hires individuals based on their job skills, expertise and ability to maintain professional relationships with fellow employees, patients, parents and visitors. A personal interview, formal education and training, previous work experience, references and a criminal background investigation are all factors used to select the best candidates. The hospital does not discriminate against prospective or current employees based on the race, color, religion, sex, national origin, age, disability, creed, genetic information, sexual orientation, gender identity or expression, ancestry or veteran status. A drug screen will be performed upon hire. Children's Mercy is smoke and tobacco free. CM is committed to creating a workforce that supports the diverse backgrounds of our patients and families. We know that our greatest strengths come from the people who make up our team, so we hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our hospital stronger and our patient care more compassionate. If you share our values and our enthusiasm for service, you will find a home at CM. In recruiting for our team, we welcome the unique contributions that you can bring, including education, ideas, culture, and beliefs.

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What you will be doing: Demonstrate proficiency in various Microsoft applications (e.g., Word, Excel, PowerPoint, SharePoint, Lists, Forms, etc.) Coordinate and schedule internal and external meetings Provide administrative support for clinical trials/to Investigator Engagement (e.g., data entry, troubleshooting, etc.) Support retention-related activities by liaising with sites to address high-risk participants Administrative support for clinical trials as required - (eg: filing, collection of signatures, invoice reconciliation) Document Management - (eg: scan, fax, upload, eTMF maintenance activities) In-house administrative support for Site CDCs (eg: CDA creation/follow-up) Support Investigator Engagement business systems and process as required Internal and External meeting support As applicable, SIP Support for Investigator Engagement: Support retention-related activities including calls with Medical/National Leaders or for Enrollment Support Data entry of Vault Clinical Enrollment Metrics Collate reports/key information in preparation for site discussions/visits Troubleshoot platform issues related to DCT/referral capabilities (e.g., Florence, StudyTeam, etc.) Submit PO increases & support external customer interactions Tracking Diversity to help us make informed decisions for pivoting where needed & Community Outreach Requests Coordination Coordinate IE Site Visit Requests across Therapeutic Areas You are: Knowledge of Good Documentation Practices Excellent computer skills with experience in a variety of software packages Fluency in English both written and oral. High level of attention to detail Strong self-management, communication and organizational skills Flexibility Excellent problem solving skills Ability to work in a virtual team and across cultures Willingness to Pacific time hours when needed. - candidates ideally located in PST MST or CST time zones (Not EST) What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Department Operations Employment Type Full Time Location Kansas City Research Institute Workplace type Onsite Reporting To Taleah Brown Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing:** + Demonstrate proficiency in various Microsoft applications (e.g., Word, Excel, PowerPoint, SharePoint, Lists, Forms, etc.) + Coordinate and schedule internal and external meetings + Provide administrative support for clinical trials/to Investigator Engagement (e.g., data entry, troubleshooting, etc.) + Support retention-related activities by liaising with sites to address high-risk participants + Administrative support for clinical trials as required - (eg: filing, collection of signatures, invoice reconciliation) + Document Management - (eg: scan, fax, upload, eTMF maintenance activities) + In-house administrative support for Site CDCs (eg: CDA creation/follow-up) + Support Investigator Engagement business systems and process as required + Internal and External meeting support + As applicable, SIP Support for Investigator Engagement: + Support retention-related activities including calls with Medical/National Leaders or for Enrollment Support + Data entry of Vault Clinical Enrollment Metrics + Collate reports/key information in preparation for site discussions/visits + Troubleshoot platform issues related to DCT/referral capabilities (e.g., Florence, StudyTeam, etc.) + Submit PO increases & support external customer interactions + Tracking Diversity to help us make informed decisions for pivoting where needed & Community Outreach Requests Coordination + Coordinate IE Site Visit Requests across Therapeutic Areas **You are:** + Knowledge of Good Documentation Practices + Excellent computer skills with experience in a variety of software packages + Fluency in English both written and oral. + High level of attention to detail + Strong self-management, communication and organizational skills + Flexibility + Excellent problem solving skills + Ability to work in a virtual team and across cultures + Willingness to Pacific time hours when needed. - candidates ideally located in PST MST or CST time zones (Not EST) **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What you will be doing: Demonstrate proficiency in various Microsoft applications (e.g., Word, Excel, PowerPoint, SharePoint, Lists, Forms, etc.) Coordinate and schedule internal and external meetings Provide administrative support for clinical trials/to Investigator Engagement (e.g., data entry, troubleshooting, etc.) Support retention-related activities by liaising with sites to address high-risk participants Administrative support for clinical trials as required - (eg: filing, collection of signatures, invoice reconciliation) Document Management - (eg: scan, fax, upload, eTMF maintenance activities) In-house administrative support for Site CDCs (eg: CDA creation/follow-up) Support Investigator Engagement business systems and process as required Internal and External meeting support As applicable, SIP Support for Investigator Engagement: Support retention-related activities including calls with Medical/National Leaders or for Enrollment Support Data entry of Vault Clinical Enrollment Metrics Collate reports/key information in preparation for site discussions/visits Troubleshoot platform issues related to DCT/referral capabilities (e.g., Florence, StudyTeam, etc.) Submit PO increases & support external customer interactions Tracking Diversity to help us make informed decisions for pivoting where needed & Community Outreach Requests Coordination Coordinate IE Site Visit Requests across Therapeutic Areas You are: Knowledge of Good Documentation Practices Excellent computer skills with experience in a variety of software packages Fluency in English both written and oral. High level of attention to detail Strong self-management, communication and organizational skills Flexibility Excellent problem solving skills Ability to work in a virtual team and across cultures Willingness to Pacific time hours when needed. - candidates ideally located in PST MST or CST time zones (Not EST) What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

The University of Iowa Health Care, Department of Radiology is seeking to hire one applicant for a Clinical Trials Research Assistant/Data Manager (25006305) or Research Associate (25006308). Please apply to the specific position you wish to be considered for, or both. The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager! The Clinical Trials Research Assistant/Data Manager is responsible for the screening, recruitment, consenting, enrolling, assessment and monitoring of subjects for studies using novel magnetic resonance imaging to evaluate lung function in chronic lung diseases, including lung transplant rejection, asthma, chronic obstructive pulmonary disease, and lung cancer. In addition, this position will be responsible for assuring study compliance and reviewing data quality and management and communicating concerns to the principal investigator. Other job requirements will include organization of data for analysis, support for paper and grant submissions, and coordination of research activities with a diverse group of investigators. Duties include: Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects. Assist with subject recruitment by mining databases and EPIC. Assist with clinical and data coordination for research activities and set up supplies for study visits. Participates in clinical research visits, which includes Epic documentation, checking vitals, portable pulmonary function testing, drawing blood and placement of IV's. Assist in managing data, including the storage, reporting and auditing to assess quality assurance. Perform all data processing tasks; enter data, verify data, generate queries, etc. Coordinate the processing of data from various sites/centers/studies. Process specimens per protocol, as well as store specimens, maintain lab areas, inventories, orders. Assist in retrieval of basic study data as it pertains to specimens. Monitors visit reports for studies. Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions. Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures. Design and coordinate field tests for data collection forms and assist in the design of these procedures Manages and maintain protocols. Research, change, and submit protocol amendments for IRB approval. Prepares IRB documents for protocol approval, modifications and yearly renewals Monitors protocol status as it is process through the IRB. Responsible for conducting training of new protocols and changes to existing protocols. May provide training to other lab staff as required by the study protocol. University of Iowa Health Care-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. Percent of Time: 100% Schedule: Mon - Fri 8:00 am - 4:30 pm Location: Iowa City, IA Pay Grade: 3A **************************************** Required Qualifications: • Bachelor's Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required. • Six months-one year of clinical research experience is required. • Excellent written, verbal communication, interpersonal and organizational skills are required. • Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study. • Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information. • Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat Desirable Qualifications: • Ability to work independently and manage multiple priorities or studies at one time. • Previous experience and participation with clinical trials is highly desired. • Knowledge of regulatory guidelines and procedures as set forth by the IRB is highly desired. • Research protocol management experience including single and multi-institutional studies • Experience with medical research data management • Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders. • Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems. Benefits Highlights: • Regular salaried position. Located in Iowa City, Iowa • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans • For more information about Why Iowa? Click here Application Process: To be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position. Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check. For additional questions, please contact Mason Garcia at **********************. Additional Information Compensation Contact Information

Scheduled Hours 40 Performs a variety of research, data base and clerical duties of a routine and technical nature in support of clinical research to ensure adherence to protocols and quality of information received. Job Description Primary Duties & Responsibilities: * Maintains and updates site demographics on computer database; logs forms received and file as appropriate; prepares reports from database to include weekly reports and other reports as requested. * Receives and disseminates study-related regulatory documents and correspondence; assists in screening documents for completeness and compliance with protocol and appropriate regulations; assists in investigating incomplete, inaccurate or missing documents to ensure accuracy and completeness of data. * Communicates and coordinates with other study personnel as required to include data entry and randomization of personnel, pharmacy, laboratories, study sponsors and others as needed for study implementation and routine problem resolution. * Attends routine meetings and other meetings related to the clinical research; stays abreast of information and any changes to study protocol. Working Conditions: Job Location/Working Conditions * Normal office environment. Physical Effort * Typically sitting at a desk or table. Equipment * Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time. Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications/Professional Licenses: No specific certification/professional license is required for this position. Work Experience: Customer Service (1 Year) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job WashU seeks highly motivated individuals who are able to perform duties in a manner consistent with our core mission and guiding principles. Preferred Qualifications Education: No additional education unless stated elsewhere in the job posting. Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: Medical Customer Service (1 Year) Skills: Detail-Oriented, Information Organization, Interpersonal Communication Grade C06-H Salary Range $17.34 - $25.40 / Hourly The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits Statement Personal * Up to 22 days of vacation, 10 recognized holidays, and sick time. * Competitive health insurance packages with priority appointments and lower copays/coinsurance. * Take advantage of our free Metro transit U-Pass for eligible employees. * WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness * Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family * We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. * WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO Statement Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Enters data in EDC and answers queries; Obtains vital signs and ECGs; May perform blood draws; Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Request and track medical record requests; Enters data in EDC and answers queries; Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and Perform all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). Must possess strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.