Clinical research associate jobs in Ankeny, IA - 36 jobs

, you must reside in the same country where the job is located. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions * Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. * Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. * Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Collaborate and liaise with study team members for project execution support as appropriate. * If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. * If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications * Bachelor's Degree Degree in scientific discipline or health care preferred. * Requires at least 2 years of year of on-site monitoring experience. * Equivalent combination of education, training and experience may be accepted in lieu of degree. * Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. * i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. * Good therapeutic and protocol knowledge as provided in company training. * Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). * Written and verbal communication skills including good command of English language. * Organizational and problem-solving skills. * Effective time and financial management skills. * Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

BASIC FUNCTION: Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols. The position requires the academic knowledge of a specific discipline and professional licensure in a clinically-related field related to the study. Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility. KEY AREAS OF RESPONSIBILITY: Research/Clinical Activities: Perform clinical and translational research studies. Protocol Development and Study Responsibilities: Assist in protocol development and provide input into descriptions of routine research procedures. Subject Recruitment and Enrollment: Schedule trial related procedures and visits. Data Collection and Monitoring: Collect and enter clinical and translational research data required by the sponsors in a timely manner. Regulatory Guidelines and Documents: Report any reportable events to appropriate parties. Human Resources/Leadership: Provide direction, assignments, feedback, coaching and counseling to assure outcomes are achieved. Financial Responsibility: Contribute to identification of increased cost/inefficient spending and cost containment measures. REQUIRED QUALIFICATIONS A Bachelor's degree or an equivalent combination of education and experience. Excellent written and verbal communication skills are required. Certification by the American Registry of Diagnostic Medical Sonographers or other nationally recognized accreditation organizations for primary specialty. At least two year's experience acquiring and analyzing cardiac ultrasound images. Excellent written and verbal communication skills are required. DERSIRABLE QUALIFICATIONS Registered Diagnostic Cardiac Sonographer certification. Registered Vascular Technologist certification. Position and Application Details In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission: Resume Cover Letter Job openings are posted for a minimum of 7 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact **********************. Additional Information Compensation Contact Information

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

BASIC FUNCTION: Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols. The position requires the academic knowledge of a specific discipline and professional licensure in a clinically-related field related to the study. Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility. KEY AREAS OF RESPONSIBILITY: Research/Clinical Activities: * Perform clinical and translational research studies. Protocol Development and Study Responsibilities: * Assist in protocol development and provide input into descriptions of routine research procedures. Subject Recruitment and Enrollment: * Schedule trial related procedures and visits. Data Collection and Monitoring: * Collect and enter clinical and translational research data required by the sponsors in a timely manner. Regulatory Guidelines and Documents: * Report any reportable events to appropriate parties. Human Resources/Leadership: * Provide direction, assignments, feedback, coaching and counseling to assure outcomes are achieved. Financial Responsibility: * Contribute to identification of increased cost/inefficient spending and cost containment measures. REQUIRED QUALIFICATIONS * A Bachelor's degree or an equivalent combination of education and experience. * Excellent written and verbal communication skills are required. * Certification by the American Registry of Diagnostic Medical Sonographers or other nationally recognized accreditation organizations for primary specialty. * At least two year's experience acquiring and analyzing cardiac ultrasound images. * Excellent written and verbal communication skills are required. DERSIRABLE QUALIFICATIONS * Registered Diagnostic Cardiac Sonographer certification. * Registered Vascular Technologist certification. Position and Application Details In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission: * Resume * Cover Letter Job openings are posted for a minimum of 7 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact **********************. Additional Information * Classification Title: Clinical/HC Research Associate * Appointment Type: Professional and Scientific * Schedule: Part-time Compensation * Pay Level: 5A Contact Information * Organization: Healthcare * Contact Name: Ashley Nelson * Contact Email: **********************

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

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.

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

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_

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.

CRC Nurse - Ames, IA (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We have an incredible opportunity for a Clinical Research Coordinator Nurse (CRC Nurse) to join ICON's Accellacare team. The CRC Nurse is responsible for completing trial assignments in an autonomous, accurate, and timely manner. The CRC Nurse is performing technical and clinical requirements of study protocols as ordered by the investigator. This role is with Accellacare (********************************** , part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. **Details** : + **Location:** Onsite (McFarland Clinic - 1015 Duff Avenue, Ames, IA 50010) + **Hours** : Monday - Friday, 8:00am - 5:00pm ET (no weekends or holidays) **What you will be doing:** + Coordinating and conducting clinical trial procedures according to protocol requirements + Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator + Collecting and documenting patient data accurately and efficiently + Assisting in patient recruitment, screening, and enrollment processes + Providing nursing care and support to trial participants + Collaborating with interdisciplinary teams to ensure trial compliance and quality data collection **Your profile:** + Bachelor's degree in Nursing or equivalent qualification + LPN required; RN preferred + Prior experience in clinical research coordination (preferred) + Strong understanding of GCP guidelines and regulatory requirements + Excellent communication skills + Organizational skills with attention to detail + Problem-solving skills \#LI-Onsite \#LI-SB4 \#LI-Accellacare **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

CRC Nurse - Ames, IA (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a Clinical Research Coordinator Nurse (CRC Nurse) to join ICON's Accellacare team. The CRC Nurse is responsible for completing trial assignments in an autonomous, accurate, and timely manner. The CRC Nurse is performing technical and clinical requirements of study protocols as ordered by the investigator. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Details: Location: Onsite (McFarland Clinic - 1015 Duff Avenue, Ames, IA 50010) Hours: Monday - Friday, 8:00am - 5:00pm ET (no weekends or holidays) What you will be doing: Coordinating and conducting clinical trial procedures according to protocol requirements Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator Collecting and documenting patient data accurately and efficiently Assisting in patient recruitment, screening, and enrollment processes Providing nursing care and support to trial participants Collaborating with interdisciplinary teams to ensure trial compliance and quality data collection Your profile: Bachelor's degree in Nursing or equivalent qualification LPN required; RN preferred Prior experience in clinical research coordination (preferred) Strong understanding of GCP guidelines and regulatory requirements Excellent communication skills Organizational skills with attention to detail Problem-solving skills #LI-Onsite #LI-SB4 #LI-Accellacare 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

Job Description Are you passionate about delivering outstanding customer service? Do you thrive in a fast-paced, people-focused environment? Rock Valley Physical Therapy is looking for a full-time Clinic Experience Associate to join our team in Cedar Rapids, IA. As a Clinic Experience Associate, you'll be a key player in creating a positive, seamless experience for every patient who walks through our doors. Your role will be essential in keeping our clinic running smoothly and efficiently. Day-to-day responsibilities include: Greeting and checking in patients with warmth and professionalism Scheduling appointments and managing the clinic calendar Verifying insurance and collecting accurate patient information Answering phone calls and responding to patient inquiries Supporting the front desk with a focus on detail and organization Why Rock Valley? At Rock Valley Physical Therapy, we don't just treat patients-we build relationships. Our team is known for its positive energy, teamwork, and commitment to exceptional care. As a Clinic Experience Associate, you'll be at the heart of that mission, helping patients feel heard, supported, and valued from start to finish. Ready to Make a Difference? If you're looking for a rewarding opportunity in healthcare where you can make a real impact every day, we'd love to meet you. Apply today and take the first step toward joining the Rock Valley Physical Therapy team.

People are a company's greatest resource, which is why caring for patients and keeping them healthy is so important. Proactive MD offers a comprehensive health management solution that extends well beyond the clinic walls. By engaging patients and offering them a personal relationship with a primary care provider, we can deliver measurably better outcomes, making people happier, healthier, and more productive while significantly lowering overall medical costs. We put patients' health first because amazing care yields amazing results. JOB SUMMARY The Occupational Health Clinical Coordinator will supervise and assist with health center operations as delegated by the Regional Director of Clinical Operations. They will show initiative and demonstrate sound decision-making and problem-solving techniques, lead through example in training and support of teams. The Occupational Health Clinical Coordinator will travel between assigned health centers to support health center services of primary care and occupational health. The goal of this position is to support assigned care teams to provide efficient & safe health center occupational health operations while ensuring our patient promise is delivered according to regulatory and quality standards. The mission of the role is to serve as a conduit of effective and professional communication between the client occupational health service and clinical team in this client-facing role. The Occupational Health Clinical Coordinator will work closely with the Account Manager, Clinical Operations Team, Medical Affairs Team Leader, and Client HR team. ESSENTIAL DUTIES AND RESPONSIBILITIES Observe day-to-day administrative and care team activities at assigned health centers. Make scheduled site visits to each assigned health center determined by leadership as applicable. Monitor operational efficiency to include but not limited to participating in interviews, precepting, and focused re-training in collaboration with Enterprise Training Manager and Regional Director of Clinical Operations. The Occupational Health Clinical Coordinator will be responsible for the orientation of oncoming clinical support staff. Their orientation will be specific to the designated client workflows and will include training related to the expectations at each Health Center for occupational health program testing compliance and primary care services. Monitor, investigate and respond to patient escalations and survey responses. Report and support clinical occurrences and any remedial actions as directed by the Quality team. Serve onsite as clinical staff as needed to improve efficiency and promote service excellence. Monitor clinical systems to ensure that all operational best practices are followed. Examples include but are not limited to- patient cases addressed, patient through put, appropriate inventory and dispensing practices, and scheduling best practices. Prepare reporting and participate in Proactive MD and client meetings, alongside the Account Manager, to ensure excellent communication and collaboration towards Client program goals. Participate in client meetings as well as Client Corporate on-site events as scheduled. Identify and report to Regional Director of Clinical Operations and/or Medical Affairs Site Leader of any concerns related to operations and staff performance/behavior. Assist Regional Director of Clinical Operations with other duties, responsibilities, and projects as assigned. KNOWLEDGE, SKILLS, & ABILITIES Required: Graduate from an accredited School of Nursing Holds a current and active licensure to practice as a Registered Nurse. Willingness to obtain multi-state/compact RN License and other states as applicable. Minimum one year of direct occupational health clinical experience in an outpatient setting. A firm understanding and experience with Occupational Health and Safety programs. Demonstrated knowledge of occupational health related regulatory guidelines and standards (DOT, OSHA, NIOSH). Demonstrated proficiency in MS Office products use including Outlook, Excel, Word, and PowerPoint. Experience and proficiency using an EMR application in a healthcare setting. Strong organization and communication skills. Ability to communicate effectively and maintain working relationships with people from diverse backgrounds. Ability to prioritize needs and plan work accordingly while being nimble to changing priorities based on business needs. Ability to properly handle sensitive and confidential information (including HIPAA and PHI) in accordance with federal and state laws and company policies. Current BLS certification or ability to obtain within the first 90 days of hire. DOT Breath Alcohol Technician certification or ability to obtain within the first 90 days of hire. DOT Urine Specimen Collector certification or ability to obtain within the first 90 days of hire. Must be willing to travel. Preferred: Bachelor's degree in nursing (BSN) from a four-year college or university Direct experience conducting hands-on education and clinical training. Direct experience with auditing and performing quality assurance audit processes. Direct experience with providing the following occupational health services to patients: Audiometric Testing, Drug and Alcohol Testing, OSHA Medical Surveillance Program Administration, Respirator Fit Testing, Respirator Medical Evaluations, Spirometry Testing, and Work-related Illness/Injury Care. Leadership experience Outpatient or Primary care experience POSITION TYPE & EXPECTED HOURS OF WORK This role is considered a full-time, exempt position which is required to be onsite in the clinical environment 5 days per week. Evening and weekend work is infrequent but may occasionally be required as business needs dictate. TRAVEL Domestic travel is required and should be expected up to 50% of the position's overall responsibilities.

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

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

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 Senior Scientist, Clinical is responsible for the safety and efficacy in the target species for new animal pharmaceutical and biological research and development projects, line extensions and maintaining existing licensed products. This role provides clinical study design and implementation including resource and budget planning from protocol to execution and to final study report for submission to regulatory agencies for animal pharmaceutical and biological projects in both lab and field conditions. The incumbent fulfills a role as a subject matter expert in representing his/her function (e.g. on development teams, regulatory authority meetings and key Opinion Leaders). The Senior Scientist, Clinical acts as the Clinical Representative as assigned for all stages of product development. This role resents clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles. The incumbent may lead a Clinical Team as Clinical Leader and is responsible for development and implementation of the clinical strategy. The Clinical Leader serves as the representative on the Core Team. **Duties & Responsibilities** + Independently initiates and coordinates strategic scientific experiments with a predefined goal including developing new methodologies, protocols and/or test procedures that contribute to innovation and core group/research goals and reflect expert knowledge. + Responsible for overall study design, execution, and reporting to achieve project milestones. + Designs clinical studies to earn label claims and new product licenses/marketing authorizations consistent with the TPP and in compliance with global regulatory guidance and corporate standards for data integrity and animal welfare. + May direct and oversee experimental study design and data analysis/results of junior-level scientists. + Demonstrates expertise in a specific project-relevant area or technology. + May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects. + Keeps abreast of relevant literature. + Develops visibility outside of functional area and effectively interacts scientifically with Key Opinion Leaders in relevant fields of research. + Publishes research in peer reviewed journals and presents data at national/international meetings as requested. + Skillfully collaborates across functions (internal and external stakeholders) to assure clinical plans and activities for project teams are delivered efficiently, while supporting continuous improvement in quality including, speed and value of processes supporting studies including protocol and forms, test article availability & suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting. + Develops and leverages external providers, academia and Contract Research Organizations as necessary. + Mentors, coaches, and trains colleagues, especially clinical research associates/monitors, on best practices for study execution with flawless speed and compliance, professional & collaborative team member behaviors, accountability, and alignment within Pharma Clinical and with all stakeholders. + Provides technical content (safety and efficacy data) for local and international regulatory submissions and/or leads clinical discussions in authority meetings and/or develops clinical and regulatory strategy. + Develops the clinical strategy and works effectively toward achieving the project goals as defined in the TPP. + Assumes leadership (as the clinical leader or clinical representative) for clinical programs within multi-disciplinary Project Teams for the effective research and development of pharmaceutical projects. + Interacts with Project Leaders, members of the Project Teams and stakeholders. + Responsible for clinical project progress, including timelines, deliverable and budgetary responsibilities. **Requirements** + DVM preferred with five (5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization required. OR + PhD (with significant experience in a veterinary-relevant field such as parasitology or animal nutrition) with five (5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization required. OR + Master's Degree (with significant experience in a veterinary-relevant field such as parasitology or animal nutrition) with ten (10) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization required. + Board Certification and/or advanced degree (MS or PhD) in addition to DVM is a plus. + Clinical veterinary practice experience is preferred. + Interest in developing therapeutics a plus. + Minimum of five years (5) of broad experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization or equivalent combination of education and experience. + Demonstrates industry-leading knowledge of field. + An analytical thinker. + Excellent skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving project objectives. + Strong leadership skills. + Able to lead (e.g. the Clinical team) without formal authority. + Research methodology experience. + Fosters innovation. + A problem solver. + Outstanding / Good communication and interpersonal skills. + A collaborative team player. + Possesses a customer service orientation, delivering results and executing in a fast and focused manner. + Exceptional planning and organizational skills with a quality orientation. + Strives for business process excellence. + Accepts accountability and ownership. + Exhibits integrity and trust. + Willingness to travel (>10% annual travel). + English: Fluent (read, write and speak). + Ability to communicate effectively both orally and in writing in an inter-disciplinary and international environment. + Leadership experience: One to three (1-3) years leading projects. + Demonstrated knowledge of the product life cycle process. + Experienced in project/program management. + Exhibits business and technical knowledge. **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. **Desired Skills, Experience and Abilities** **Additional Duties & Responsibilites** : + Ensures that risks and changes to either the Research Target Profile (RTP) or Target Product Profile (TPP) are communicated into the project team. + Provides clinical input to the either RTP or TPP and influences the Project from the clinical veterinary and scientific perspective. + Takes on Clinical Lead, Study Director, Monitor and Investigator roles as necessary. + Responsible for the design, organization, conduct, timely completion and reporting of assigned clinical R&D studies to establish safety and efficacy of new pharmaceuticals, and to develop new claims and uses for existing products. + Ensures compliance around GSP, GLP, GCP, PV, animal welfare and local regulatory requirements. + Study Director responsibilities are described in the applicable GLP standards. + Contributes or leads internal initiatives such as SOP development, patent filings and due diligence. 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.

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 * Classification Title: Clin Trials Rsrch Asst/Data Mg * Appointment Type: Professional and Scientific * Schedule: Full-time * Work Modality Options: On Campus Compensation * Pay Level: 3A Contact Information * Organization: Healthcare * Contact Name: Mason Garcia * Contact Email: **********************

Are you passionate about delivering outstanding customer service? Do you thrive in a fast-paced, people-focused environment? Rock Valley Physical Therapy is looking for a full-time Clinic Experience Associate to join our team in Cedar Rapids, IA. As a Clinic Experience Associate, you'll be a key player in creating a positive, seamless experience for every patient who walks through our doors. Your role will be essential in keeping our clinic running smoothly and efficiently. Day-to-day responsibilities include: Greeting and checking in patients with warmth and professionalism Scheduling appointments and managing the clinic calendar Verifying insurance and collecting accurate patient information Answering phone calls and responding to patient inquiries Supporting the front desk with a focus on detail and organization Why Rock Valley? At Rock Valley Physical Therapy, we don't just treat patients-we build relationships. Our team is known for its positive energy, teamwork, and commitment to exceptional care. As a Clinic Experience Associate, you'll be at the heart of that mission, helping patients feel heard, supported, and valued from start to finish. Ready to Make a Difference? If you're looking for a rewarding opportunity in healthcare where you can make a real impact every day, we'd love to meet you. Apply today and take the first step toward joining the Rock Valley Physical Therapy team.

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