Clinical research coordinator jobs in Iowa - 22 jobs

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 Compensation Contact Information

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.

The research nurse coordinator will apply clinical and administrative skills in carrying out clinical research protocols. The coordinator will be involved in all aspects of research including patient recruitment and enrollment, patient education and assessment, data collection and monitoring, regulatory documentation, and coordination of research visits with all appropriate disciplines. The successful applicant will independently manage one or more primary research protocols, and work closely with other coordinators assisting with related protocols. This position requires a Master's degree in nursing or a combination of a Bachelor's degree in nursing and relevant experience. Research/Clinical Activities * Perform clinical/health care research activities. * Meet with patients during visits. * Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patients. * Review of subject's medical history. * Clinical assessment of study participants. * May administer study medication. * Educate patients and families about administration and use of study medications. * Answer patient questions and address concerns between study visits. * Schedule patient visits within parameters specified to study protocol. * Assure compliance with study protocol. * Work closely with a range of health care professionals to carry out study assessments. Protocol Development and Study Responsibilities * Assist in protocol development and provide input into descriptions of routine research procedures. * Assure study visit compliance within window of visit schedule. * Assist with resolution of monitoring visit issues. * Serve as liaison to local health care practitioners, agencies, and sponsors. Subject Recruitment and Enrollment * Screen for subject eligibility and obtain informed consent for clinical trials/studies. * Relay information to principal investigator and verify patient eligibility. * Schedule trial-related procedures and visits. * Assist with subject assessments during study participation. Data Collection and Monitoring * Collect and enter clinical research data required by the sponsors in a timely manner. * Assist with determining validity of data obtained. * Maintain detailed record keeping in accordance with clinical research requirements. Regulatory Guidelines and Documents * Collect and maintain regulatory documents. * Prepare regulatory forms and documentation according to protocol requirements. * Report any reportable events to appropriate party within specified time range. Human Resources/Leadership * May provide functional and/or administrative supervision. Financial Responsibility * Assist in budget development and monitoring for study. * Assist in reviewing invoices and work performed before billing. Education Requirements * Master's degree in nursing or a combination of a Bachelor's degree in nursing and relevant experience. * A current, valid Iowa Registered Nurse License. Experience Requirements * At least 1 year of previous clinical experience. * Demonstrated experience with Microsoft Office Suites. Highly Desired Qualifications * 1-3 years' experience and participation with clinical trials. * Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research. * Previous experience with Pediatric patient population. * Experience in clinical trial management including IRB protocols. * Previous experience with research subject recruitment. * Previous experience in a role requiring independent decision making. 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 ************************************** This position is not eligible for University sponsorship for employment authorization. * Additional Information * Classification Title: Clinical/HC Research Associate * Appointment Type: Professional and Scientific * Schedule: Full-time * Work Modality Options: On Campus Compensation * Pay Level: 5A Contact Information * Organization: Healthcare * Contact Name: Natasha Johnson * Contact Email: **************************************

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.

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

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

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

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.

The research nurse coordinator will apply clinical and administrative skills in carrying out clinical research protocols. The coordinator will be involved in all aspects of research including patient recruitment and enrollment, patient education and assessment, data collection and monitoring, regulatory documentation, and coordination of research visits with all appropriate disciplines. The successful applicant will independently manage one or more primary research protocols, and work closely with other coordinators assisting with related protocols. This position requires a Master's degree in nursing or a combination of a Bachelor's degree in nursing and relevant experience. Research/Clinical Activities Perform clinical/health care research activities. Meet with patients during visits. Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patients. Review of subject's medical history. Clinical assessment of study participants. May administer study medication. Educate patients and families about administration and use of study medications. Answer patient questions and address concerns between study visits. Schedule patient visits within parameters specified to study protocol. Assure compliance with study protocol. Work closely with a range of health care professionals to carry out study assessments. Protocol Development and Study Responsibilities Assist in protocol development and provide input into descriptions of routine research procedures. Assure study visit compliance within window of visit schedule. Assist with resolution of monitoring visit issues. Serve as liaison to local health care practitioners, agencies, and sponsors. Subject Recruitment and Enrollment Screen for subject eligibility and obtain informed consent for clinical trials/studies. Relay information to principal investigator and verify patient eligibility. Schedule trial-related procedures and visits. Assist with subject assessments during study participation. Data Collection and Monitoring Collect and enter clinical research data required by the sponsors in a timely manner. Assist with determining validity of data obtained. Maintain detailed record keeping in accordance with clinical research requirements. Regulatory Guidelines and Documents Collect and maintain regulatory documents. Prepare regulatory forms and documentation according to protocol requirements. Report any reportable events to appropriate party within specified time range. Human Resources/Leadership May provide functional and/or administrative supervision. Financial Responsibility Assist in budget development and monitoring for study. Assist in reviewing invoices and work performed before billing. Education Requirements Master's degree in nursing or a combination of a Bachelor's degree in nursing and relevant experience. A current, valid Iowa Registered Nurse License. Experience Requirements At least 1 year of previous clinical experience. Demonstrated experience with Microsoft Office Suites. Highly Desired Qualifications 1-3 years' experience and participation with clinical trials. Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research. Previous experience with Pediatric patient population. Experience in clinical trial management including IRB protocols. Previous experience with research subject recruitment. Previous experience in a role requiring independent decision making. 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 ************************************** This position is not eligible for University sponsorship for employment authorization. Additional Information Compensation Contact Information

**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.

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: **********************

Job DescriptionPeople 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. Powered by JazzHR MCM9GAEpRk

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

BASIC FUNCTION Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols in patients living with HIV in the UIHC Virology Clinic as part of the Ryan White Program. 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/health care research activities in a skilled/specialized area. * Screen patient for study eligibility and consent for clinical trials. * Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient. * Coordinate patient care needs and obtain medical information from local physicians, labs or other providers assuring confidentiality of information according to UIHC policy and HIDAA regulations. * Relay information to principle investigator and verify patient eligibility. * Administer study medication and identify adverse reactions. Protocol Development and Study Responsibilities: * Assist in the design, development, execution, administration and maintenance of Virology Clinic protocols and clinical studies and provide input into descriptions of complex research procedures. * Assist patients with problems related to protocol. Oversee CRF development. * Review query reports. Resolve all monitoring visit issues. * Perform and monitor randomizations. * Develop complex study materials. * Serve as liaison to local health care practitioners, agencies, and sponsors. Subject Recruitment and Enrollment: * Screen, recruit, enroll and obtain informed consent for clinical research activities and perform skilled work in a specialized area of research. * Oversee the recruitment of subjects and scheduling of trial-related procedures. * Prepare study recruitment materials. Develop complex study recruitment materials. Data Collection and Monitoring: * Participate in the design; development and testing of clinical research trial data systems. * Validate data and make recommendations for resolution. * Revise and implement change in data collection. * Obtain documentation of the hospitalizations, as well as provide notification to the Principal Investigator, Study Sponsor and FDA as required per protocol. Regulatory Guidelines and Documents: * Manage and organize regulatory documentation. * Prepare regulatory submissions. * Perform on-site audits of research and clinical data. * Monitor compliance of regulatory guidelines and proper maintenance of documents. * Prepare and present Institutional Review Boards or other submissions and required regulatory documents. * May recommend corrective action for reportable events. * Maintain records and services provided and work within individual protocol budgets. Assist in writing and submission of initial and continuing reports to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research regulatory groups. Human Resources/Leadership: * May provide functional and/or administrative supervision. * Mentor new staff under direction. Financial Responsibility: * Develop and administer budget for study(ies). * Serve as a liaison to the University Business Office to identify exact patient tests and procedures, which are paid for by study sponsors, and to assist with questions related to billing for protocol treatment procedures. QUALIFICATIONS * A Bachelor's degree in Nursing or an equivalent combination of education and experience is required. * A Current, valid Iowa Registered Nurse license is required. * Excellent written and verbal communication skills are required. * 3 years of experience is required. * Occasional overnight and weekend travel to study meetings is required. * Previous experience in HIV/AIDS field or education is desirable. * Experience with patient triage is desirable. * Research protocol management experience including single and multi-institutional studies and experience with protocol therapy and medical research data management is desirable. * Experience with and participation on clinical trials; clinical background and knowledge of regulatory guidelines and procedures is desirable. 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: **********************

BASIC FUNCTION University of Iowa Health Care Department of Internal Medicine, Division of Cardiovascular Medicine is seeking a Research Nurse with a current Registered Nurse license in Iowa to apply clinical skills and evaluate and execute research protocols in Adult Interventional Cardiology. Research studies will be conducted throughout the Heart and Vascular Center (inpatient, catheterization lab and ambulatory clinics). The position requires the academic knowledge of anatomy, physiology, and pathophysiology in adults. This position will have a large involvement with coordinating multiple parties. KEY AREAS OF RESPONSIBILITY Research/Clinical Activities: Perform clinical/health care research activities in for interventional cardiology research which includes bedside management of subject participants before, during and post interventional procedures as well as assessment during outpatient clinic visits or telephone contacts. Screen patient for study eligibility and consent for clinical trials. Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient. Relay information to principal investigator and verify patient eligibility. Administer study medication and identify adverse reactions. Assure compliance with study protocol. Obtain and process clinical trial specimens. Assist participants with problems related to their cardiovascular protocol therapy such as consultation when calling reporting concerns related to: returning for emergency evaluation in the case of side effects, questions related to treatment procedures or other related issues. Protocol Development and Study Responsibilities: Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures. Coordinate and oversee the administration and maintenance of clinical trial protocols. Assist patients with problems related to protocol. Develop study materials. Review query reports. Resolve all monitoring visit issues. Perform and monitor treatment randomizations. Serve as liaison to local health care practitioners, agencies, and sponsors. Ensure human subjects protection and provide care that is safe, effective, and efficient. Subject Recruitment and Enrollment: Screen, recruit, enroll and obtain informed consent for clinical research activities and perform skilled work in interventional cardiology research. Oversee the recruitment of subjects and scheduling of trial-related procedures. Provide thorough explanation about clinical trial to potential subjects. Seek out clarification from principal investigator or sub investigator when necessary. Prepare and/or develop study recruitment and educational materials. Data Collection and Monitoring: Participate in the design; development and testing of clinical research trial data systems. Collect and enter concise clinical research data required by the study sponsors according to the sponsors', Institutional Research Board and Good Clinical Practice requirements. Validate data and make recommendations for resolution. Revise and implement change in data collection. Regulatory Guidelines and Documents: Manage and organize regulatory documentation. Prepare and present Institutional Review Boards or other submissions and required regulatory documents. Perform on-site audits of research and clinical data. Monitor compliance of regulatory guidelines and proper maintenance of documents. May recommend corrective action for reportable events. Human Resources/Leadership: May provide functional and/or administrative supervision. Facilitate education and training activities. Adhere to institutional policies and guidelines. Mentor new staff under direction. Financial Responsibility: Develop and administer budget for study(ies). Contribute to identification of increased cost/inefficient spending and cost containment measures. REQUIRED QUALIFICATIONS A Bachelor's degree in Nursing (BSN) or an equivalent combination of education and experience. A Current, valid Iowa Registered Nurse license. 2 years of nursing or 1 year of clinical research experience. BLS certification. Ability to work some weekends, evenings and nights per study protocol assessment requirements is required. Excellent written, verbal and interpersonal communication skills. Knowledge of cardiovascular medicine procedures and cardiovascular medicine terminology is required. DESIRED QUALIFICATIONS Prior experience in clinical research, regulatory guidelines and procedures and study budget development. Knowledge of cardiovascular medicine procedures and cardiovascular medicine terminology. Previous nursing experience with the cardiovascular medicine diseases patient population. Phlebotomy experience. Knowledge of IRB guidelines and procedures. Certification in Good Clinical Practice. Excellent time management skills and ability to perform detail-oriented work. Experience in a position requiring independent decision-making. Knowledge of EPIC and experience with computer software applications (MS Word, Excel, Outlook and PowerPoint). 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

BASIC FUNCTION University of Iowa Health Care Department of Internal Medicine, Division of Cardiovascular Medicine is seeking a Research Nurse with a current Registered Nurse license in Iowa to apply clinical skills and evaluate and execute research protocols in Adult Interventional Cardiology. Research studies will be conducted throughout the Heart and Vascular Center (inpatient, catheterization lab and ambulatory clinics). The position requires the academic knowledge of anatomy, physiology, and pathophysiology in adults. This position will have a large involvement with coordinating multiple parties. KEY AREAS OF RESPONSIBILITY Research/Clinical Activities: * Perform clinical/health care research activities in for interventional cardiology research which includes bedside management of subject participants before, during and post interventional procedures as well as assessment during outpatient clinic visits or telephone contacts. Screen patient for study eligibility and consent for clinical trials. * Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient. * Relay information to principal investigator and verify patient eligibility. * Administer study medication and identify adverse reactions. * Assure compliance with study protocol. * Obtain and process clinical trial specimens. * Assist participants with problems related to their cardiovascular protocol therapy such as consultation when calling reporting concerns related to: returning for emergency evaluation in the case of side effects, questions related to treatment procedures or other related issues. Protocol Development and Study Responsibilities: * Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures. * Coordinate and oversee the administration and maintenance of clinical trial protocols. * Assist patients with problems related to protocol. * Develop study materials. * Review query reports. Resolve all monitoring visit issues. * Perform and monitor treatment randomizations. * Serve as liaison to local health care practitioners, agencies, and sponsors. * Ensure human subjects protection and provide care that is safe, effective, and efficient. Subject Recruitment and Enrollment: * Screen, recruit, enroll and obtain informed consent for clinical research activities and perform skilled work in interventional cardiology research. * Oversee the recruitment of subjects and scheduling of trial-related procedures. * Provide thorough explanation about clinical trial to potential subjects. Seek out clarification from principal investigator or sub investigator when necessary. * Prepare and/or develop study recruitment and educational materials. Data Collection and Monitoring: * Participate in the design; development and testing of clinical research trial data systems. * Collect and enter concise clinical research data required by the study sponsors according to the sponsors', Institutional Research Board and Good Clinical Practice requirements. * Validate data and make recommendations for resolution. * Revise and implement change in data collection. Regulatory Guidelines and Documents: * Manage and organize regulatory documentation. * Prepare and present Institutional Review Boards or other submissions and required regulatory documents. * Perform on-site audits of research and clinical data. * Monitor compliance of regulatory guidelines and proper maintenance of documents. * May recommend corrective action for reportable events. Human Resources/Leadership: * May provide functional and/or administrative supervision. * Facilitate education and training activities. * Adhere to institutional policies and guidelines. * Mentor new staff under direction. Financial Responsibility: * Develop and administer budget for study(ies). * Contribute to identification of increased cost/inefficient spending and cost containment measures. REQUIRED QUALIFICATIONS * A Bachelor's degree in Nursing (BSN) or an equivalent combination of education and experience. * A Current, valid Iowa Registered Nurse license. * 2 years of nursing or 1 year of clinical research experience. * BLS certification. * Ability to work some weekends, evenings and nights per study protocol assessment requirements is required. * Excellent written, verbal and interpersonal communication skills. * Knowledge of cardiovascular medicine procedures and cardiovascular medicine terminology is required. DESIRED QUALIFICATIONS * Prior experience in clinical research, regulatory guidelines and procedures and study budget development. * Knowledge of cardiovascular medicine procedures and cardiovascular medicine terminology. * Previous nursing experience with the cardiovascular medicine diseases patient population. * Phlebotomy experience. * Knowledge of IRB guidelines and procedures. * Certification in Good Clinical Practice. * Excellent time management skills and ability to perform detail-oriented work. * Experience in a position requiring independent decision-making. * Knowledge of EPIC and experience with computer software applications (MS Word, Excel, Outlook and PowerPoint). 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: Full-time Compensation * Pay Level: 5A Contact Information * Organization: Healthcare * Contact Name: Ashley Nelson * Contact Email: **********************

BASIC FUNCTION Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols in patients living with HIV in the UIHC Virology Clinic as part of the Ryan White Program. 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/health care research activities in a skilled/specialized area. Screen patient for study eligibility and consent for clinical trials. Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient. Coordinate patient care needs and obtain medical information from local physicians, labs or other providers assuring confidentiality of information according to UIHC policy and HIDAA regulations. Relay information to principle investigator and verify patient eligibility. Administer study medication and identify adverse reactions. Protocol Development and Study Responsibilities: Assist in the design, development, execution, administration and maintenance of Virology Clinic protocols and clinical studies and provide input into descriptions of complex research procedures. Assist patients with problems related to protocol. Oversee CRF development. Review query reports. Resolve all monitoring visit issues. Perform and monitor randomizations. Develop complex study materials. Serve as liaison to local health care practitioners, agencies, and sponsors. Subject Recruitment and Enrollment: Screen, recruit, enroll and obtain informed consent for clinical research activities and perform skilled work in a specialized area of research. Oversee the recruitment of subjects and scheduling of trial-related procedures. Prepare study recruitment materials. Develop complex study recruitment materials. Data Collection and Monitoring: Participate in the design; development and testing of clinical research trial data systems. Validate data and make recommendations for resolution. Revise and implement change in data collection. Obtain documentation of the hospitalizations, as well as provide notification to the Principal Investigator, Study Sponsor and FDA as required per protocol. Regulatory Guidelines and Documents: Manage and organize regulatory documentation. Prepare regulatory submissions. Perform on-site audits of research and clinical data. Monitor compliance of regulatory guidelines and proper maintenance of documents. Prepare and present Institutional Review Boards or other submissions and required regulatory documents. May recommend corrective action for reportable events. Maintain records and services provided and work within individual protocol budgets. Assist in writing and submission of initial and continuing reports to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research regulatory groups. Human Resources/Leadership: May provide functional and/or administrative supervision. Mentor new staff under direction. Financial Responsibility: Develop and administer budget for study(ies). Serve as a liaison to the University Business Office to identify exact patient tests and procedures, which are paid for by study sponsors, and to assist with questions related to billing for protocol treatment procedures. QUALIFICATIONS A Bachelor's degree in Nursing or an equivalent combination of education and experience is required. A Current, valid Iowa Registered Nurse license is required. Excellent written and verbal communication skills are required. 3 years of experience is required. Occasional overnight and weekend travel to study meetings is required. Previous experience in HIV/AIDS field or education is desirable. Experience with patient triage is desirable. Research protocol management experience including single and multi-institutional studies and experience with protocol therapy and medical research data management is desirable. Experience with and participation on clinical trials; clinical background and knowledge of regulatory guidelines and procedures is desirable. 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