Title: Clinical Research Associate Type: Remote - Field - Chicago/Wisconsin 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 Manager 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 AZ 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. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager. Accountabilities - 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 trainings 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 AZ 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 (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 LSM 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 finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ 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, CSP or ICH-GCP compliance issues to Local Management and/or 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 LSM and CQM. - Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM 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. - Ensures compliance with AstraZeneca’s Code of Ethics, 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. - Collaborates with local MSLs as directed by LSM or line manager. Requirements: - Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*). - 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 AZ Therapeutic Areas. - Basic understanding of the drug development process. - Good understanding of Clinical Study Management including monitoring, study drug handling and data management. - Excellent attention to details. - Good written and verbal communication skills. - Good collaboration and interpersonal skills. - Good negotiation skills. - Ability to travel nationally/internationally as required. - Valid driving license The annual base pay for this position ranges from $112,154.40 - $168,231.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 16-Mar-2026 Closing Date 03-Apr-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial • Lead cross-functional study execution team in support of study deliverables • Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership • Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs • Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews • Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files • Participates in service provider selection process as a part of outsourcing activities • Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required • Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations • Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents • Manage clinical trial budgets, providing ongoing financial reporting and projections • Negotiate and finalize site contracts and budgets • Perform and manage data review process on an ongoing basis • Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed • Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues • Ensures tracking and review of protocol deviations and assesses impact on study data • Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget • Provides oversight for forecasting of clinical supplies, including study drug and supplies.

The Department of Neurology is seeking a Clinical Research Manager who will deliver and organize work plans with 20+ clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC). Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Clinical Research Manager works under the general supervision of a Pl(s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration and regulatory compliance. Supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites. Specific Duties & Responsibilities - Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the Pl. - Participate in scientific discussions with collaborators, Pl's, and funding organizations. - Collaborate with Pl to ensure operational feasibility of proposed protocol/study design. - Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s). - Develop or oversee the development of consent form(s) for clinical trials based on protocol(s). - Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the Pl. - Train and provide oversight of research data management and regulatory issues. - Work with commercial and/or government agency sponsors to determine what group can commit to considering patient population, available resources, and cost of providing services. - Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget. - Ensure clinical research protocol has a completed Prospective Reimbursement Analysis {PRA) and processes/systems are in place to ensure the PRA is followed when required. - Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing. - Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials. - Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data. - Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial. - Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies. - Contribute to presentations and manuscripts. - Hire, supervise and manage performance of other exempt-level research staff. - Other duties as assigned. Minimum Qualifications - Bachelor's Degree in a related field. - Five years of related experience in clinical research in an academic, - Strong organizational, analytical, and leadership skills with experience in multi-site coordination. - Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Preferred Qualifications - Master's Degree in a related field. - Certification as a Clinical Research Professional. - Formal project management training or certification. - Advanced knowledge of GCP/ICH and local regulations. - Proficiency in Microsoft Office Suite and SharePoint; ability to learn new software (e.g., eIRB, EDC systems). Technical Skills & Expected Level of Proficiency - Budget Management - Advanced - Clinical Study Design - Advanced - Good Clinical Practices - Advanced - Interpersonal Skills - Advanced - Oral and Written Communications - Advanced - Project Management - Advanced - Record Keeping - Advanced - Regulatory Compliance - Advanced - Strategic Planning - Advanced The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs. Classified Title: Clinical Research Manager Job Posting Title (Working Title): Clinical Research Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $55,800 - $97,600 Annually ($76,700 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm FLSA Status: Exempt Location: Remote Department name: SOM Neuro BIOS Personnel area: School of Medicine

We anticipate the application window for this opening will close on - 24 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. As a Senior Field Clinical Engineer (FCE), you will play a critical role in supporting clinical studies and advancing neuromodulation technologies. This position serves as a technical bridge between engineering, clinical research teams, and physicians to ensure successful study implementation, high-quality data collection, and effective use of investigational and commercial devices. The primary focus of the role is supporting clinical trials while providing clinical insights that help improve existing products and guide development of new technologies. Responsibilities may include the following and other duties may be assigned. - Support all phases of clinical research studies, including investigator identification, site nomination, activation, training, enrollment support, and study close-out. - Provide on-site technical support during clinical procedures and initial product implants, evaluating device performance in the clinical setting. - Serve as a liaison between engineering, clinical research teams, and physicians to ensure proper device use and protocol adherence. - Monitor study progress and support sites in maintaining high-quality data collection and documentation. - Build and maintain strong relationships with investigators and clinical teams to understand capabilities, research interests, and patient needs. - Provide feedback to engineering and R&D teams to support product improvements and development of new technologies. - Collaborate with clinical research partners on study protocols, execution, and documentation. - Educate internal teams, sales partners, and customers on technology, clinical applications, and best practices, particularly during product launches. Location: Remote within US We are seeking a committed professional to join our team, required to reside within the region and drive or fly to multiple accounts throughout the US. A valid driver's license is essential for this role, which also involves 70% – 75% amount of travel outside the region, presenting opportunities for broader engagement. Occasional work across multiple time zones . Ability to travel up to: 70-75% domestically with some international travel Must Have (Minimum Requirements) To be considered for this role, please ensure the minimum requirements are evident on your resume. - Bachelor’s degree and 4 years of experience in clinical research/clinical or as a clinical specialist/field clinical engineer/clinical sales rep or - Advanced degree and 2 years of experience in clinical research/clinical or as a clinical specialist/field clinical engineer/clinical sales rep Nice to Have (Preferred Qualifications) - Experience at Medtronic or within the medical device industry - Experience in the management of clinical devices - Neuromodulation or Pelvic Health device training strongly preferred - Experience in biomedical engineering, hospital/clinic and/or medical sales - 2+ years of experience in clinical research, Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$104,000.00 - $156,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.