Clinical research associate jobs in Ames, IA

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

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

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

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Scientist, Clinical is responsible for the safety and efficacy in the target species for new animal pharmaceutical and biological research and development projects, line extensions and maintaining existing licensed products. This role provides clinical study design and implementation including resource and budget planning from protocol to execution and to final study report for submission to regulatory agencies for animal pharmaceutical and biological projects in both lab and field conditions. The incumbent fulfills a role as a subject matter expert in representing his/her function (e.g. on development teams, regulatory authority meetings and key Opinion Leaders). The Senior Scientist, Clinical acts as the Clinical Representative as assigned for all stages of product development. This role resents clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles. The incumbent may lead a Clinical Team as Clinical Leader and is responsible for development and implementation of the clinical strategy. The Clinical Leader serves as the representative on the Core Team. **Duties & Responsibilities** + Independently initiates and coordinates strategic scientific experiments with a predefined goal including developing new methodologies, protocols and/or test procedures that contribute to innovation and core group/research goals and reflect expert knowledge. + Responsible for overall study design, execution, and reporting to achieve project milestones. + Designs clinical studies to earn label claims and new product licenses/marketing authorizations consistent with the TPP and in compliance with global regulatory guidance and corporate standards for data integrity and animal welfare. + May direct and oversee experimental study design and data analysis/results of junior-level scientists. + Demonstrates expertise in a specific project-relevant area or technology. + May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects. + Keeps abreast of relevant literature. + Develops visibility outside of functional area and effectively interacts scientifically with Key Opinion Leaders in relevant fields of research. + Publishes research in peer reviewed journals and presents data at national/international meetings as requested. + Skillfully collaborates across functions (internal and external stakeholders) to assure clinical plans and activities for project teams are delivered efficiently, while supporting continuous improvement in quality including, speed and value of processes supporting studies including protocol and forms, test article availability & suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting. + Develops and leverages external providers, academia and Contract Research Organizations as necessary. + Mentors, coaches, and trains colleagues, especially clinical research associates/monitors, on best practices for study execution with flawless speed and compliance, professional & collaborative team member behaviors, accountability, and alignment within Pharma Clinical and with all stakeholders. + Provides technical content (safety and efficacy data) for local and international regulatory submissions and/or leads clinical discussions in authority meetings and/or develops clinical and regulatory strategy. + Develops the clinical strategy and works effectively toward achieving the project goals as defined in the TPP. + Assumes leadership (as the clinical leader or clinical representative) for clinical programs within multi-disciplinary Project Teams for the effective research and development of pharmaceutical projects. + Interacts with Project Leaders, members of the Project Teams and stakeholders. + Responsible for clinical project progress, including timelines, deliverable and budgetary responsibilities. **Requirements** + DVM preferred with five (5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization required. OR + PhD (with significant experience in a veterinary-relevant field such as parasitology or animal nutrition) with five (5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization required. OR + Master's Degree (with significant experience in a veterinary-relevant field such as parasitology or animal nutrition) with ten (10) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization required. + Board Certification and/or advanced degree (MS or PhD) in addition to DVM is a plus. + Clinical veterinary practice experience is preferred. + Interest in developing therapeutics a plus. + Minimum of five years (5) of broad experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization or equivalent combination of education and experience. + Demonstrates industry-leading knowledge of field. + An analytical thinker. + Excellent skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving project objectives. + Strong leadership skills. + Able to lead (e.g. the Clinical team) without formal authority. + Research methodology experience. + Fosters innovation. + A problem solver. + Outstanding / Good communication and interpersonal skills. + A collaborative team player. + Possesses a customer service orientation, delivering results and executing in a fast and focused manner. + Exceptional planning and organizational skills with a quality orientation. + Strives for business process excellence. + Accepts accountability and ownership. + Exhibits integrity and trust. + Willingness to travel (>10% annual travel). + English: Fluent (read, write and speak). + Ability to communicate effectively both orally and in writing in an inter-disciplinary and international environment. + Leadership experience: One to three (1-3) years leading projects. + Demonstrated knowledge of the product life cycle process. + Experienced in project/program management. + Exhibits business and technical knowledge. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** **Additional Duties & Responsibilites** : + Ensures that risks and changes to either the Research Target Profile (RTP) or Target Product Profile (TPP) are communicated into the project team. + Provides clinical input to the either RTP or TPP and influences the Project from the clinical veterinary and scientific perspective. + Takes on Clinical Lead, Study Director, Monitor and Investigator roles as necessary. + Responsible for the design, organization, conduct, timely completion and reporting of assigned clinical R&D studies to establish safety and efficacy of new pharmaceuticals, and to develop new claims and uses for existing products. + Ensures compliance around GSP, GLP, GCP, PV, animal welfare and local regulatory requirements. + Study Director responsibilities are described in the applicable GLP standards. + Contributes or leads internal initiatives such as SOP development, patent filings and due diligence. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Medical Assistant/Clinical Research Coordinator Schedule Onsite Monday-Friday 8 am-5 pm Assists the CRCs and PIs with all administrative tasks related to clinical research trials Phlebotomy and specimen processing Conducts telephone or in-person interviews with participants including screening for eligibility Performs follow-up for appointments and manages scheduling of appointments (by telephone, e-mail, and/or mail) with study participants Prepares,mails and processes questionnaires and other study correspondence Assistin tracking study participants using MS Excel Keeps accurate and detailed records and files of work Reviews,edits, cleans, and enters participant data into a database Assists with regulatory management May assist with literature reviews for proposal submissions and manuscriptpreparation Bookkeeping related to study budgets (ordering supplies, requesting checks for payment& participant incentives) Miscellaneous administrative tasks (typing labels, copying, faxing, meeting preparation,note-taking, transcribing audio files, etc.) Qualifications MUST have 1 year of Medical Assistant or Patient Care experience Customer service experience High School Diploma or General Education Development (GED) required MUST have experience with EHR/EMR systems MUST have experience with Microsoft Office Suite (Outlook, Excel, Word, etc.) Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Ames,IA. Application Deadline This position is anticipated to close on May 9, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

CRC Nurse - Ames, IA (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a Clinical Research Coordinator Nurse (CRC Nurse) to join ICON's Accellacare team. The CRC Nurse is responsible for completing trial assignments in an autonomous, accurate, and timely manner. The CRC Nurse is performing technical and clinical requirements of study protocols as ordered by the investigator. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Details: Location: Onsite (McFarland Clinic - 1015 Duff Avenue, Ames, IA 50010) Hours: Monday - Friday, 8:00am - 5:00pm ET (no weekends or holidays) What you will be doing: Coordinating and conducting clinical trial procedures according to protocol requirements Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator Collecting and documenting patient data accurately and efficiently Assisting in patient recruitment, screening, and enrollment processes Providing nursing care and support to trial participants Collaborating with interdisciplinary teams to ensure trial compliance and quality data collection Your profile: Bachelor's degree in Nursing or equivalent qualification LPN required; RN preferred Prior experience in clinical research coordination (preferred) Strong understanding of GCP guidelines and regulatory requirements Excellent communication skills Organizational skills with attention to detail Problem-solving skills #LI-Onsite #LI-SB4 #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, 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

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

This position provides research project support to requesting department to ensure timelines and effectiveness in activation and completion of needed research projects. Responsible for routine to moderately complex project coordination / project management as well as communication and documentation as required by the research departments. **Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings** We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, and Washington** **Essential Functions** + **Research Support and Administration:** Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources. + **Project Planning & Execution:** Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed. + **Budget & Scope Management:** Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing. + **Study Requirements & Compliance:** Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements. + **Quality Assurance & Documentation:** Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices. + **Study Lifecycle Management:** Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator. + **Medicare Coverage Analysis:** Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review. + **Auditing & Risk Management:** Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations. **Skills** + Budgeting + Financial negotiation + Attention to detail + Multitasking + Clear written and verbal communication + Task Prioritization + Process Improvement + Critical thinking + Collaboration + Research **Physical Requirements** + Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues. + Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately. + Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands. + Expected to bend, lift, and carry patient files, documents, equipment, and supplies. + Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment. + For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles. **Physical Requirements:** **Minimum Qualifications** + Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment. + Demonstrated experience working in a collaborative team environment. + Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications. + Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required. + Clinical licensure, experience or certification may be required due to grant funding requirements. · Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified. + Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **OR** + Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **Preferred Qualifications** + Experience in clinical research setting, including relevant study management experience. · Experience in a healthcare or hospital setting. **Location:** Intermountain Health Intermountain Medical Center **Work City:** Murray **Work State:** Utah **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $27.65 - $43.55 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.

Provide efficient, quality-oriented customer service duties through greeting and patient interactions, information requests, scheduling patients and coordinating services. This involves scheduling evaluations as well as recurrent appointments for therapy services. Provide prospective patients with clinic information to be an advocate of clinic therapists and services to persuade patients to choose our therapists for therapy services. Educates the patient on visit expectations, insurance benefits/information, and financial responsibilities. Assists in data input for both productivity, patient satisfaction, and clinical outcomes. Exemplifies servant leadership principles through all actions and interaction (patients, team members, physicians and staff, and family members/friends in the clinic, etc.). This position will Float between clinic sites and will report directly to the Clinic Director. Key Responsibilities: Greets individuals entering the premises. Provides directions, answers questions and meets a variety of customer service needs. Displays a caring and courteous attitude and represents the clinic in a positive manner. Exercises flexibility and excellent customer service. Performs receptionist duties to include signing patients in, collecting co-pays, taking new referral information, faxing information, handling phone calls, computer operations, email etiquette, and assisting others as needed to ensure patient safety and comfort. Answers a high volume of calls and maintains a rapid response rate according to agreed standards. Log information on calls received, where required and maintains detailed and accurate records. Cooperates with all staff to achieve goals and to maintain good employee relations, interdepartmental relations and public relations. Provide prospective patients with clinic information to be an advocate of clinic therapists and services to persuade patients to choose our therapists for therapy service. Schedules patient for clinics and makes reminder calls. Receives referrals from a variety of sources, completes appropriate paperwork. Contacts physician for required orders and medical records. Maintain referral logs and distributes to appropriate parties. Inputs patient and insurance data into the computer. Type and word-process various documents and electronic information. Create financial and statistical tools and reports using spreadsheets, TrackVia, etc. Manage, organize and update relevant data using database applications. Analyze and interpret financial statistics and other data and produce relevant reports. Communicate and provide information by relevant methods internally and externally to assist and enable organizational operations and effective service to connecting groups. Interpret instructions and issues arising, and implement actions according to policies and procedures. Arrange and participate in meetings, conferences and project team activities. Maintain regular consistent and professional attendance, punctuality, and personal appearance. Manage clinician scheduling to ensure optimal scheduling for clinic to achieve Quality Index Minimal Productivity Standards (QIMPS). Manage point of service collections (co-pays, co-insurances, deductibles, self-pay). Proactively identifies ways to improve job function and collaborates with supervisor and team members to implement improvements. Maintains excellent working relationship with the medical professionals and other health related facilities and organizations. Demonstrates ability to prioritize tasks/responsibilities and complete duties within allotted time. Demonstrates and understands the importance of and respect for the rights, confidentiality, dignity, and individuality of each patient in all interactions. Demonstrates honesty and integrity always in the care and use of patient and clinic property. Demonstrates respect for co-workers and responds to needs of patients by complying with clinic policies. Demonstrates satisfactory level of interpersonal skills to interact and deal tactfully with facility staff, administration, patients, families, customers, vendors, and government agencies. Requirements High School Diploma Knowledgeable of basic computer operations Excellent organization and customer services skills Minimum of one year office experience in a medical setting preferred. Ability to project a professional image. (maintains patient confidentiality and strong sense of ethics) Ability to communicate and collaborate with a variety of teams and individuals Working knowledge and ability to apply professional standards in job situations. Strong organizational, prioritizing and analytical skills. Strong customer service orientation Ability to make independent decisions when circumstances warrant. Working knowledge of personal computer and software applications used in job functions Why Choose Iowa Ortho? At Iowa Ortho, we are guided by our IMPACT values, and we believe in fostering a culture that prioritizes both professional excellence and compassionate care: Innovation that Drives Positive Outcomes (I) Motivation for Exceptional Care (M) Passion for Quality in Everything We Do (P) Accountability Through Open and Honest Communication (A) Commitment to Continued Growth (C) Teamwork (T) Competitive Benefit Package: Competitive pay, health, dental, paid time off, paid holidays, 401(k) with company match, profit-sharing, employee discounts and more. Center of Excellence: Physician-owned orthopedic clinic and surgery center dedicated to providing exceptional medical care to the people of central Iowa. Discover why Iowa Ortho is a recognized center of excellence in orthopedic care. Cutting-Edge Environment: Work in a state-of-the-art facility that embraces the latest advancements in medical technology. Team Atmosphere: Join a collaborative team that supports one another and is committed to enhancing patient care. Professional Growth: Opportunities for career advancement and continuous learning. Join our team and be a part of our commitment to delivering gold-standard healthcare! *Please note our first point of contact may be by email. Please check your spam folder, as unknown senders sometimes wind up in spam or junk. Iowa Ortho is a privately held medical practice. Candidates who receive a conditional offer of employment at Iowa Ortho will be required to complete a criminal background check, education verification, reference checks, and an initial TB test. Iowa Ortho is committed to a diverse and inclusive workplace. Iowa Ortho is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

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 University of Iowa Health Care, Department of Radiology is seeking a Clinical/Health Care Research Associate to support the MRI Recharge Facility by providing management and oversight for research studies from beginning to end of project. This position will perform clinical and healthcare research activities related to Magnetic Resonance Imaging (MRI). Oversee scheduling, billing, and setting annual rate for facility. Develop budgets and utilization projections and reports for facility usage. Explore grant opportunities for equipment and research funding. Develop and implement procedures to support staff and users of facility. Coordinate research meetings, workshops, and events. Work with University investigators and coordinators to facilitate new project submissions. Help maintain facility equipment and ensure proper function. Provide oversight and direction for staff, students, and users of the facility Duties include: Research/Clinical Activities: • Function as a technical expert in MRI research. Perform clinical/health care research activities related to MRI. • Conduct complex research experiments in human and animal MRI imaging. • Prepare and participate in monitoring visits; may perform activities such as patient assessments and review of medical history. • Assure compliance with study protocol. • Prepare research and grant proposals. Explore grant opportunities for research facility. • Coordinate research teams and documents for grant submission. • Maintain SMRT membership to keep current on cutting edge MRI techniques and changes in the field. • Develop, troubleshoot, and formulate protocols and hypotheses in a specialized field/discipline. • Develop and implement research plan in collaboration with PI. • Maintain research website and online scheduler. Help maintain information on the facility website to communicate with the outside users as well as document internal procedures. • Facilitate technologist support and equipment use for research studies. • Work with University investigators and research coordinators to develop and submit new MRI research projects. Protocol Development and Study Responsibilities: • Review literature in the development of new imaging protocols for human and animal MRI imaging. • Assist in protocol development and provide input into descriptions of routine MRI research procedures. • Develop study materials. • Liaison with external funding agencies related to supporting facility research. Subject Recruitment and Enrollment: • Screen, recruit, and obtain informed consents for clinical trials/studies. • Assist principal investigator to determine subject eligibility. • Schedule trial related procedures and visits. • Assist with subject assessments during study participation. Data Collection and Monitoring: • Investigate and perform critical analysis of current MRI data and MRI literature to advise principal investigators on the proper approach and techniques to achieve optimal research outcomes. • Monitor and track research protocols for data collection. • Ensure proper archiving of research images, monitor compliance with University, state and federal regulations. • Assist with determining validity of data obtained. Regulatory Guidelines and Documents: • Assists with preparation of manuscripts for publication and/or presentation at national meetings. • Develop and perform quality assurance procedures. • Monitor compliance with contract and grant terms in accordance with University policies and state and federal regulations. • Develop, implement, and oversee local program guidelines. • Track and ensure IRB/IACUC compliance for facility users. • Prepare documents for investigator IRB submission. • Communicate with University departments to assure compliance and adherence to University, state, and federal policies. • Collect and maintain regulatory documents from subjects and assist in preparation of required regulatory forms and documentation according to protocol. • Report any reportable events to appropriate party. Leadership: • Adhere to institutional policies and guidelines. • Provide supervision, oversight and direction for the students, staff and users of the research facility. • Provide secondary supervision, support, and management of research technologists. • Develop and organize training sessions for student users of facility equipment, disseminate training materials. Financial Responsibility: • Create and monitor budgets, establish fiscal controls, prepare fund allocations to comply with internal and sponsor deadlines. • Oversee and generate monthly billing to facility users. • Analyze, monitor, and report financial data, information and reports. • Reconcile income and expenditures. • Assist in budget development and management of resources/supplies for study. • Contribute to identification of increased cost/inefficient spending and cost containment measures. University of Iowa Health Care-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. Percent of Time: 100% Schedule: Mon - Fri 8:00 am - 4:30 pm Location: Iowa City, IA Pay Grade: 4A **************************************** Education Requirement: Completion of a bachelor's degree or successful completion of two-year or other approved program by Joint Review Committee in Radiologic Technology education or an equivalent combination of education and experience. Required Qualifications: • 3-5 years of experience operating MRI scanners. • Certification by the American Registry of Radiologic Technologist (ARRT) in Magnetic Resonance Imaging (MRI). • Excellent written, verbal and interpersonal communication skills. • Ability to work independently with self motivation to complete the tasks at hand. • Must be proficient in computer software applications (Microsoft Office Suite). • Demonstrated ability to train and supervise others. • Demonstrated experience providing positive communication and care to patients or research subjects. • Comfortable working with large and small animals undergoing MRI imaging. Desirable Qualifications: • Clinical research experience. • Competency with multiple computing platforms (e.g., PC, Linux, Apple). • Able to troubleshoot equipment failures and implement repairs, install and test equipment, perform routine backups of research systems. • Familiarity with image processing and analysis. Benefits Highlights: • Regular salaried position. Located in Iowa City, Iowa • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans • For more information about Why Iowa? Click here Application Process: To be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position. Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled. Additional Information Compensation Contact Information

**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.

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_

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager! The Clinical Trials Research Assistant/Data Manager is responsible for performing clinical/health care research activities in support of clinical trials in the Department of Radiology. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen recruit, enroll and obtain informed consent of clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Mange and organized regulatory documentation. Position Responsibilities: Key Areas of Responsibility * Research/Clinical Activities; Subject Recruitment and Enrollment * Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects. * Assist with subject recruitment by mining databases and EPIC. * Assist with clinical and data coordination for research activities and set up supplies for study visits. * Participates in clinical research visits, which includes Epic documentation, checking vitals, provision of research questionnaires, patient education, and coordination of future research visits * Coordinate day-today clinical trial operations within the procedural environment * Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs * Schedule and coordinate study visits, procedures, imaging, laboratory testing, and follow-up appointments * Prepare and manage investigational decides, procedural kits, and study supplies * Coordinate post-procedure monitoring, discharge instructions, and follow-up care * Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use * Track and report adverse events, serious adverse events, and unanticipated problems * Provide patient education related to procedures, medications, and follow-up requirements * Data Collection and Monitoring * Assist in managing data, including the storage, reporting and auditing to assess quality assurance * Perform all data processing tasks; enter data, verify data, generate queries, etc. * Coordinate the processing of data from various sites/centers/studies * Ensure accurate documentation of procedural, device, and imaging data * Respond to data queries and maintain data quality * Prepare for and participate in monitoring visits and audits * Maintain drug/device accountability and reconciliation logs * Regulatory Guidelines and Documents * Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions * Ensure compliance with GCP, FDA regulations, and institutional policies * Maintain training and delegation documentation * Support regulatory audits and inspections * Protocol Development/Management and Study Responsibilities * Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures * Design and coordinate field tests for data collecting forms and assist in the design of these procedures * Manages and maintain protocols * Research, change, and submit protocol amendments for IRB approval * Prepares IRB documents for protocol approval, modifications and yearly renewals * Monitors protocol status as it is process through the IRB * Assist in conducting training of new protocols and changes to existing protocols * Assist with feasibility assessments and study start-up activities * Review protocols for operational feasibility and workflow integration * Coordinate site initiation, investigator meetings, and sponsor communications * Support in tracking study milestones, enrollment targets, and budgets * Support study close-out activities and document archiving * Human Resources/Leadership * May provide training to other research staff as required by the study protocol The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job. University of Iowa Health Care-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. Percent of Time: 100% Schedule: Mon - Fri 8:00 am - 4:30 pm Location: Iowa City, IA Pay Grade: 3A **************************************** Required Qualifications: * Bachelor's Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required. * Six months-one year of clinical research experience is required. * Excellent written, verbal communication, interpersonal and organizational skills are required. * Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study. * Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information. * Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat Desirable Qualifications: * Ability to work independently and manage multiple priorities or studies at one time. * Previous experience and participation with clinical trials is highly desired. * Knowledge of regulatory guidelines and procedures as set forth by the IRB is highly desired. * Research protocol management experience including single and multi-institutional studies * Experience with medical research data management * Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders. * Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems. Benefits Highlights: * Regular salaried position. Located in Iowa City, Iowa * Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans * For more information about Why Iowa? Click here Application Process: To be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position. Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check. For additional questions, please contact Lori Steffens at ***********************. Additional Information * Classification Title: Clin Trials Rsrch Asst/Data Mg * Appointment Type: Professional and Scientific * Schedule: Full-time * Work Modality Options: On Campus Compensation * Pay Level: 3A Contact Information * Organization: Healthcare * Contact Name: Lori Steffens * 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

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager! The Clinical Trials Research Assistant/Data Manager is responsible for performing clinical/health care research activities in support of clinical trials in the Department of Radiology. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen recruit, enroll and obtain informed consent of clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Mange and organized regulatory documentation. Position Responsibilities: Key Areas of Responsibility Research/Clinical Activities; Subject Recruitment and Enrollment Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects. Assist with subject recruitment by mining databases and EPIC. Assist with clinical and data coordination for research activities and set up supplies for study visits. Participates in clinical research visits, which includes Epic documentation, checking vitals, provision of research questionnaires, patient education, and coordination of future research visits Coordinate day-today clinical trial operations within the procedural environment Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs Schedule and coordinate study visits, procedures, imaging, laboratory testing, and follow-up appointments Prepare and manage investigational decides, procedural kits, and study supplies Coordinate post-procedure monitoring, discharge instructions, and follow-up care Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use Track and report adverse events, serious adverse events, and unanticipated problems Provide patient education related to procedures, medications, and follow-up requirements Data Collection and Monitoring Assist in managing data, including the storage, reporting and auditing to assess quality assurance Perform all data processing tasks; enter data, verify data, generate queries, etc. Coordinate the processing of data from various sites/centers/studies Ensure accurate documentation of procedural, device, and imaging data Respond to data queries and maintain data quality Prepare for and participate in monitoring visits and audits Maintain drug/device accountability and reconciliation logs Regulatory Guidelines and Documents Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions Ensure compliance with GCP, FDA regulations, and institutional policies Maintain training and delegation documentation Support regulatory audits and inspections Protocol Development/Management and Study Responsibilities Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures Design and coordinate field tests for data collecting forms and assist in the design of these procedures Manages and maintain protocols Research, change, and submit protocol amendments for IRB approval Prepares IRB documents for protocol approval, modifications and yearly renewals Monitors protocol status as it is process through the IRB Assist in conducting training of new protocols and changes to existing protocols Assist with feasibility assessments and study start-up activities Review protocols for operational feasibility and workflow integration Coordinate site initiation, investigator meetings, and sponsor communications Support in tracking study milestones, enrollment targets, and budgets Support study close-out activities and document archiving Human Resources/Leadership May provide training to other research staff as required by the study protocol The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job. University of Iowa Health Care-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. Percent of Time: 100% Schedule: Mon - Fri 8:00 am - 4:30 pm Location: Iowa City, IA Pay Grade: 3A **************************************** Required Qualifications: • Bachelor's Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required. • Six months-one year of clinical research experience is required. • Excellent written, verbal communication, interpersonal and organizational skills are required. • Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study. • Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information. • Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat Desirable Qualifications: • Ability to work independently and manage multiple priorities or studies at one time. • Previous experience and participation with clinical trials is highly desired. • Knowledge of regulatory guidelines and procedures as set forth by the IRB is highly desired. • Research protocol management experience including single and multi-institutional studies • Experience with medical research data management • Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders. • Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems. Benefits Highlights: • Regular salaried position. Located in Iowa City, Iowa • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans • For more information about Why Iowa? Click here Application Process: To be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position. Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check. For additional questions, please contact Lori Steffens at ***********************. Additional Information Compensation Contact Information