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  • Clinical Trial Documentation Coordinator

    Cypress HCM 3.8company rating

    Clinical research coordinator job in Maple Grove, MN

    The Clinical Trial Documentation Coordinator plays a vital role within the Clinical Operations team, providing seasoned administrative and logistical support across a variety of clinical trial activities. This role is responsible for ensuring studies are well-organized, audit-ready, and progressing smoothly by flexibly managing documentation, image and data tracking, payments, device logistics, and meeting coordination. As a core and consistent member of the team, the Clinical Coordinator is regarded as a peer among fellow coordinators and a reliable contributor to study success. Responsibilities: Clinical Documentation & Site Support Manage essential clinical documentation, including IRB approvals, informed consent forms, agreements, and regulatory files. Track and update CVs and credentials for study site personnel. Serve as a primary contact for clinical sites regarding documentation needs and visit scheduling. Maintain organized, audit-ready study files within electronic systems. Image & Data Management Coordinate the collection, processing, and tracking of clinical images and related data from sites and core labs. Troubleshoot and resolve data submission issues with sites and vendors to ensure completeness and timeliness. Ensure image data quality and compliance by maintaining accurate records in the EDC system. Payments & Financial Tracking Process payments to study sites, vendors, core labs, and data management groups. Maintain and update payment tracking databases; provide accrual information to the Finance team. Communicate regularly with vendors and sites to support timely and accurate financial transactions. Device & Logistics Coordination Manage logistics for study device shipments, returns, and related documentation. Track device inventory, usage, and return status. Collaborate with Operations to facilitate purchase orders and coordinate shipping logistics. Meeting & Training Support Assist with planning and coordinating investigator meetings, site coordinator trainings, and study committee meetings (in-person and virtual). Support travel arrangements and meeting logistics as needed. Prepare training materials, track participant attendance, and monitor related expenses. General Team Support Assemble and maintain study materials, binders, and equipment supplies. Provide backup support to fellow Clinical Coordinators during periods of high workload. Participate in continuous improvement efforts and team-wide initiatives. Qualifications: Associate or Bachelor's degree required; degree in life sciences, healthcare, or a related field preferred. 3-5 years of experience in clinical research, clinical trials, or a regulated healthcare setting. Strong understanding of clinical documentation requirements and trial operations. Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook); experience with EDC systems or clinical databases is highly preferred. Exceptional organizational skills with the ability to handle multiple priorities in a dynamic environment. High attention to detail, accuracy, and follow-through. Excellent communication skills and the ability to foster productive relationships with internal teams, clinical sites, and vendors. Demonstrated dedication to a coordinator-level role and a commitment to team stability and performance. Salary of $60,000 to $80,000 + 5 to 7 % bonus
    $60k-80k yearly 2d ago
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  • Clinical Research Coordinator - 248147

    Medix 4.5company rating

    Clinical research coordinator job in Minneapolis, MN

    Job Title: Clinical Research Coordinator - Bilingual (EN/ES) Schedule: Full-time; flexible schedule with M/W/F and T/Th/Sat coverage as needed. Typical hours are 7:30 AM - 3:30 PM, with occasional early-morning study visits (as early as 4:30 AM). Overview We are seeking a dedicated Clinical Research Coordinator to support all phases of clinical trials, from patient enrollment through study closeout. In this role, you will work closely with the Principal Investigator (PI) and cross-functional research teams to ensure high-quality study execution, strong patient support, and compliance with all regulatory requirements. This position is ideal for someone who thrives in a patient-focused environment. You will primarily support one site, allowing you to develop strong and meaningful relationships with the PI, study team, and patient population. Key Responsibilities Coordinate all aspects of clinical trials, including enrollment, study conduct, and closeout activities. Perform protocol-specific research procedures and support the PI throughout study execution. Serve as a liaison between investigators, sponsors, monitors, and internal study team members. Meet or exceed enrollment goals while ensuring high-quality, accurate, and timely data entry. Maintain strict compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all regulatory requirements. Foster a patient-centered environment, especially for rare disease populations with limited sample sizes. Support studies, including occasional early morning patient visits. Nice-to-Have Skills Prior experience in a clinical research setting. Phlebotomy experience is a plus. Strong organizational and multi-tasking abilities. Excellent communication and relationship-building skills. Must be bilingual in both English and Spanish. Soft Skills & Expectations Patient-focused, empathetic approach to clinical research. Strong interpersonal skills and the ability to collaborate effectively with diverse teams. Reliable follow-through and commitment to timely communication.
    $41k-57k yearly est. 1d ago
  • Senior Clinical Research Associate (FSP) - Central Region - Oncology

    Thermofisher Scientific 4.6company rating

    Clinical research coordinator job in Minneapolis, MN

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. **Essential Functions and Other Job Information:** **Essential Functions** + Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. + Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. + Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. + Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. + Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). + Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. + Responds to company, client and applicable regulatory requirements/audits/inspections. + Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. + Contributes to other project work and initiatives for process improvement, as required. **Qualifications:** **Education and Experience:** Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as traveling clinical research associate). Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. **Knowledge, Skills and Abilities:** + Effective clinical monitoring skills + Demonstrated understanding of medical/therapeutic area knowledge and medical terminology + Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents + Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving + Ability to manages Risk Based Monitoring concepts and processes + Effective oral and written communication skills, with the ability to communicate effectively with medical personnel + Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues + Effective interpersonal skills + Strong attention to detail + Effective organizational and time management skills + Ability to remain flexible and adaptable in a wide range of scenarios + Ability to work in a team or independently as required + Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software + Good English language and grammar skills + Good presentation skills **Compensation and Benefits** The salary range estimated for this position based in Illinois is $79,200.00-$136,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: + A choice of national medical and dental plans, and a national vision plan, including health incentive programs + Employee assistance and family support programs, including commuter benefits and tuition reimbursement + At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy + Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan + Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: ***************************************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
    $79.2k-136k yearly 6d ago
  • Project Coordinator, EP R&D

    Boston Scientific 4.7company rating

    Clinical research coordinator job in Arden Hills, MN

    Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the role: The EP R&D Project Coordinator will support the Electrophysiology (EP) Research & Development organization within the Cardiology business. This individual will assist in the planning, coordination, and execution of R&D projects and initiatives. The role focuses on enabling efficient project operations, supporting documentation and communication, and helping the team deliver high-quality innovation that advances Boston Scientific's EP portfolio. This position reports to the EP R&D Project Management Group Manager. Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office at least four days per week. Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: * Support R&D project manager and technical teams in the coordination and execution of project activities, ensuring alignment with key milestones and deliverables. * Partner with supporting staff across functions to ensure timely execution of physician contracting, travel, and payment. * Provide a single point of contact for physicians and local field personnel to coordinate travel logistics. * Coordinate equipment and supply readiness and shipping / customs paperwork for domestic and international events. * Fosters collaborative relationships with customers that increase organizational understanding and presence. * Assist in maintaining project documentation, schedules, and action logs. * Help facilitate project meetings, including scheduling, agenda preparation, notetaking, and follow-up tracking. * Prepare and update presentations, reports, and status summaries for internal stakeholders. * Track and monitor progress against timelines; help identify risks or delays and escalate as appropriate. * Support continuous improvement initiatives within R&D operations and project * management processes. * Manage indirect spending related to customer-facing events, including tracking, reconciliation, and reporting of event-related expenditures to ensure budget alignment and compliance with internal policies. * Maintain compliance with internal documentation standards and quality system requirements. Required qualifications * Bachelor's degree required (preferably in engineering, science, business, or related field). * Strong organizational, communication, and project coordination skills, with keen attention to detail and accuracy. * Demonstrated ability to manage multiple priorities and meet deadlines in a fast paced environment. * Highly organized, proactive, and self-directed with strong initiative and follow through. * Collaborative and adaptable team player, capable of working effectively with both technical and non-technical stakeholders. * Excellent interpersonal skills with the ability to communicate clearly and professionally across functions and levels. * Analytical and resourceful, with a desire to learn and grow within an R&D project management environment. * Ability to travel up to 10%. Preferred qualifications * Relevant experience * Experience in medical devices, healthcare, or a regulated technical industry. * Experience supporting R&D, engineering, or technical project teams. * Familiarity with electrophysiology, cardiology, or related medical technologies. * Experience managing budgets or tracking project/event-related spending. Requisition ID: 618017 Minimum Salary: $49500 Maximum Salary: $94000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see ******************************* vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Nearest Major Market: Minneapolis Job Segment: R&D Engineer, R&D, Project Manager, Electrophysiology, Medical Device, Engineering, Research, Technology, Healthcare
    $49.5k-94k yearly 37d ago
  • Senior Clinical Research Specialist

    Medtronic 4.7company rating

    Clinical research coordinator job in Minneapolis, MN

    We anticipate the application window for this opening will close on - 3 Jan 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** In this exciting role you will have primary responsibility for leading and developing clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards. This is a dynamic opportunity where you will also be involved in global clinical development activities and clinical strategy. **Prefer candidates who can work in Irvine, CA** 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. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include but are not limited to: + Develop clinical strategy and author clinical documents including but not limited to clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, clinical risk benefit analyses, and clinical marketing materials. + Collaborate with cross-functional teams, such as marketing, sales, clinical, R&D, HE&R, Quality, Compliance and Regulatory, and may represent clinical on core teams for new product development and/or product expansions. + Develop and maintain strong scientific knowledge of the therapeutic area, disease state, and current competitive landscape, with the ability to effectively write key clinical deliverables/sections of regulatory submissions, including regulatory responses. + Develop a deep understanding of clinical data: how to interpret and effectively communicate/present the data, summarizing complex results, and presenting them in a clear, concise, and scientifically accurate manner to a wide-range of audiences.. + Conduct thorough scientific literature reviews and clinical evidence mapping, manage the literature database and prepare literature reviews for external and internal stakeholders, or for regulatory submissions. + Develop and lead the execution of publication strategies in collaboration with internal and external stakeholders (e.g., physician investigators, KOLs). + Participate in the periodic reviews of recent scientific publications/conference presentations relevant to the business, draft article summaries for distribution to key stakeholders. + Plan, direct, and drive multiple business critical projects in parallel to completion on time with independence under limited supervision. + For all documents: author drafts, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers. **Must Have: Minimum Requirements** _To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume_ + Bachelor's degree in a technical discipline + Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience **Nice to Have: Preferred Qualifications** + MD or PhD degree in biomedical sciences or other relevant technical disciplines is highly preferred + Experience with clinical trials, clinical/medical and/or scientific writing or publication at Medtronic + Neurovascular medical device or stroke therapeutic area experience **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. **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):$105,600.00 - $158,400.00 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. 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will... + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email ******************* To request removal of your personal information from our systems please email *****************************
    $105.6k-158.4k yearly 41d ago
  • Manager, Clinical Research Monitoring

    Edwards Lifesciences 4.6company rating

    Clinical research coordinator job in Saint Paul, MN

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future. If you're an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. **How you will make an impact:** + Managing and leading a small team within assigned function including team budget responsibilities and managing outside contractors/vendors. Developing team members to increase business acumen and functional skills. + Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Acting as a mentor to new or junior level employees. + Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence. + Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms. + Participating in development and validation of case report forms. + Reviewing and approving monitoring visit reports. + Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees. + Reviewing and completing checklist on informed consent forms (ICF). + Providing direction and guidance to execute project deliverables in collaboration with project managers. + Identifying and evaluating clinical process improvement opportunities. **What you'll need (Required):** + Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria. + Ability to travel up to 75% domestically and internationally. **What else we look for (Preferred):** + 8+ years of related experience in cardiology trials + Master's Degree in related field + Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA, and international regulatory requirements + Ability to lead and mentor field monitors + Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity + Ability to resolve conflicts and provide clear guidance + Proficiency in trial management systems (e.g. RAVE, CTMS, Veeva, & monitoring dashboard) + Proven successful project management leadership skills + Proven expertise in MS Office Suite, including Word, Excel, and Adobe + Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives + Excellent problem-solving, organizational, analytical and critical thinking skills + Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline + Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise + Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations + Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization + Ability to work and excel within a fast paced, dynamic, and constantly changing work environment Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $123,000 to $174,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $123k-174k yearly 12d ago
  • Clinical Research Scientist Interventional Solutions

    GE Healthcare 4.8company rating

    Clinical research coordinator job in Saint Paul, MN

    Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No
    $97.6k-146.4k yearly 60d+ ago
  • Sr. Clinical Research Specialist

    Integrated Resources 4.5company rating

    Clinical research coordinator job in Minneapolis, MN

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Title: Sr. Clinical Research Specialist Location: Minneapolis, MN Duration: 24+Months (Possibility of extension) Local candidate to Minneapolis, MN needed Position Description: · The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. · Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Healthcare requirements. Position Responsibilities: · Prepare and revise study materials and/or training · Conduct training of site and/or Healthcare staff · Assist in site initiation activities (e.g. study start-up documentation preparation) · Set-up and maintain accurate progress and study status tracking logs · Assist in the preparation of reports, regulatory submissions, publications and presentations · Assist in the preparation of budgets and project plans · Identify and mitigate quality risk and/or issues associated with assigned studies/activities · May arrange conference calls, staff meetings, and training events. · Assist in the preparation and review of data · Oversee follow-up and resolution of sites issues · Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines · Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks · Contribute to process improvement initiatives and participate in training to enhance knowledge Basic Qualifications: · Bachelor's degree · 4+ years' experience in clinical research (Master's degree will substitute for 1 year experience) Desired/Preferred Qualifications: • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies • Proficient knowledge of medical terminology • Computer skill competency (MS Office products, spreadsheets, power points, etc.) • Ability to work well within teams, build relationships • Good prioritization and organizational skills, able to manage multiple tasks • Excellent oral and written communication • Positive outlook • Strong communication skills (efficient, effective, transparent) Physical Job Requirements: · 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. · 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. · Ability to travel 10-20% Additional Information We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732-844-8724 Email id - seema @irionline.com| www.irionline.com LinkedIn: https://in.linkedin.com/in/seemachawhan Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row
    $65k-95k yearly est. 60d+ ago
  • Sr Clinical Research Specialist

    Collabera 4.5company rating

    Clinical research coordinator job in Minneapolis, MN

    Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World's ‘Most Admired Companies to work for'. Job Description Position Description: The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements. Position Responsibilities: • Prepare and revise study materials and/or training • Conduct training of site and/or Medtronic staff • Assist in site initiation activities (e.g. study start-up documentation preparation) • Set-up and maintain accurate progress and study status tracking logs • Assist in the preparation of reports, regulatory submissions, publications and presentations • Assist in the preparation of budgets and project plans • Identify and mitigate quality risk and/or issues associated with assigned studies/activities • May arrange conference calls, staff meetings, and training events. • Assist in the preparation and review of data • Oversee follow-up and resolution of sites issues • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks • Contribute to process improvement initiatives and participate in training to enhance knowledge Qualifications Basic Qualifications: • Bachelors degree • 4+ years' experience in clinical research (Masters degree will substitute for 1 year experience) Desired/Preferred Qualifications: • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies • Proficient knowledge of medical terminology Additional Information If you are interested and want to apply, please contact: Ebrahim Sayarwala ebrahim.sayarwala(at )collabera.com ************
    $72k-101k yearly est. 4h ago
  • Clinical Research Associate II

    Atricure, Inc. 4.6company rating

    Clinical research coordinator job in Minnetonka, MN

    AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryo ICE cryo SPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. Position Summary: The Clinical Research Associate II (CRA II) at AtriCure is a critical role within the Clinical Affairs department, responsible for site management and/or monitoring activities during clinical trial execution. This position involves working under moderate supervision to ensure compliance with study protocols and regulatory standards. The CRA II plays a pivotal role in maintaining the integrity of clinical data while adapting to the dynamic needs of different studies. Key Responsibilities: Site Management: Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel. Support site Qualification, Initiation, Interim and Close-Out training visits. Assist with scheduling of required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes. Site Communications: Serve as the main point of contact for site communications and inquiries. Liaise with clinical study management, clinical development, site personnel, and CROs, escalating protocol or study related issues as necessary. Compliance: Ensure clinical study sites adhere to assigned study protocols and regulatory standards, notifying study management of any concerns. Data Management: Review and analyze data for accuracy and completeness. Manage the creation, resolution, and tracking of data queries. Monitoring: Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements. Safety: Process product complaints and adverse events as reported, collaborating with safety specialists to gather necessary materials for CEC meetings. Study Management: Assist in the development of study-related materials, including patient recruitment materials and newsletters. Facilitate ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites Coordinate activities with study-specific committees, vendor services, and core labs. Other Duties: Ensure appropriate translations for study documents. Contribute to process improvement initiatives and department activities. Leadership & Development: Focus on self-development with opportunities to mentor entry-level professionals. Engage in continuous learning and professional development in clinical research areas. Qualifications and Experience: Bachelor's degree with a minimum of 2 years of clinical research experience. Strong organizational and communication skills with an ability to work effectively in a team. Proficiency in Microsoft Office Suite and familiarity with clinical data management systems. Willingness to travel between 10-75% of the time. #LI-KN1 AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: *************************************************** AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ************************* AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
    $72k-101k yearly est. 60d+ ago
  • Feasibility Study Manager

    Parexel 4.5company rating

    Clinical research coordinator job in Saint Paul, MN

    **PXL FSP - Join an organization shaping smarter, faster clinical development** PXL FSP is seeking a detail‑oriented and proactive **Feasibility Study Manager** to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. **Key Responsibilities** **Survey Design & Configuration** + Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting. + Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications. + Build survey reporting templates directly within the platform or through external systems as needed. **Site & Investigator Readiness** + Perform quality checks on potential investigators before survey deployment. + Support verification of available CDAs prior to launch. + Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness. **Survey Management & Execution** + Lead survey launch activities and oversee ongoing monitoring, including: + Delegating surveys appropriately + Tracking and reconciling survey status + Ensuring thorough documentation of site notes and survey details + Identifying and consolidating invalid contact information + Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking. + Monitor country‑level response metrics to support early risk identification and mitigation planning. **Site Identification Strategy** + Execute the agreed site‑identification strategy, including application of priority site designations. + Implement the communication plan using approved study summaries, templates, and designated system email origins. + Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration. + Track CDA negotiation status for participating sites and communicate internal updates. **Close‑Out Activities** + Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks. **Minimum Qualifications** + **Education:** Bachelor's degree or equivalent. + **Experience:** 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas). \#LI-KW1 \#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.
    $94k-131k yearly est. 12d ago
  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Clinical research coordinator job in Saint Paul, MN

    NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * The physical demands described here 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. * While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
    $54.4k-80.1k yearly Auto-Apply 35d ago
  • Clinical Research Coordinator /Psychologist

    Bloomington 3.6company rating

    Clinical research coordinator job in Bloomington, MN

    Build Something Bigger - And Change Lives, Including Your Own. In 1935, Louise Whitbeck Fraser opened a school in her home for people with disabilities - defying social expectations and choosing compassion over convention. She believed everyone deserves the chance to reach their potential and thrive. Today, that same bold spirit is alive in every Fraser service. We're still building something bigger - a more inclusive, connected world where everyone belongs. At Fraser, you'll find more than a job. You'll find purpose. You'll find growth. And you'll find a place where your work changes lives - including your own. Fraser is seeking a Clinical Research Coordinator to serve as a scientific resource and supports Fraser research projects by coordinating activities, analyzing data, and communicating research findings to internal and external stakeholders regarding clinical outcomes in Specialty Healthcare. In addition,provide psychological assessment, intervention, and consultation for clients and families. Responsibilities: Scientific Resource: Manage and review study protocols/requests from internal and external stakeholders to assess relevance and resources available for such projects. Provide research reviews for staff requests that support the clinical operations of Fraser. Research Coordinator: Serve as Research consultant for staff examining clinical research. Under direction of Medical Director/Chief Clinical Officer identify primary projects that focus resources for collecting data, analyzing and communicating outcomes. Perform data collection, analysis, and reporting. Continuously audit database and identify issues of risk and process improvements to ensure accuracy and efficiency. Work in collaboration with Database Administrator to ensure successful integration of data collection and evaluation metrics into our electronic health record and practices. Data Anlayst: Perform data collection, analysis, and reporting. Continuously audit database and identify issues of risk and process improvements to ensure accuracy and efficiency. Perform data collection interviews and data entry. Work in collaboration with Database Administrator to ensure successful integration of data collection and evaluation metrics into our electronic health record and practices. Psychologist: Participate in psychological testing for clients with social, behavioral, emotional, and developmental concerns. May deliver individual and family psychotherapy, including diagnostic assessments and treatment planning. May provide group therapy, for siblings, adults, parents, and children. Provide consultation and coordination of services with others involved with the client, such as the school, county, courts, biological family, foster parents. Schedule and provide clinical services and documentation in such a way as to meet or exceed budgeted client service hour targets. Requirements: MA, MS, Psy.D., Ph.D. in Psychology required, or other graduate degree with research experience that demonstrates understanding and skill for research activities. Current active Psychology licensure from the State of Minnesota. Training and experience in clinical research required. Valid Minnesota Driver's License with acceptable record. Commitment to promoting diversity, multiculturalism, and inclusion with a focus on culturally responsive practice, internal self-awareness, and reflection. Schedule, Location and Pay: Monday- Friday standard business hours .5 FTE Research Coordinator .5 FTE Psychologist Fraser Bloomington, MN Hybrid $105,000 - $115,000 annually dependent upon qualifications Fraser Offers: Collaborative and relationship-oriented culture Scheduled performance feedback Career growth opportunities Opportunities for community involvement in Fraser organized events. Collaborative and relationship-oriented culture Fraser Offers Benefits for Full-time Employees (30+ hours per week) Medical, dental and vision insurance Health Savings Account (HSA) and Flexible Spending Account (FSA) Employee Assistance Plan (EAP) Life, AD&D and Voluntary Life Insurance Long-Term Disability, Accident Insurance, Critical Illness Insurance and Hospital Indemnity Insurance Pet Insurance 403(b) Retirement Plan with Company Match Work-Life Balance; 5 weeks of paid time off annually (18 days PTO + 9 Paid Holidays) Employee Referral Bonuses Why Join Fraser? Meaningful Impact Help individuals and families lead more connected, independent, and fulfilling lives. Your impact here is real - and lasting. Competitive Pay & Benefits Fraser offers fair pay and comprehensive benefits that support your health, well-being, and future goals. Flexibility & Work-Life Balance With flexible schedules, generous paid time off, and wellness programs, Fraser helps you care for others without sacrificing yourself. Grow Your Career With Us We invest in your development with training, licensure support, leadership pathways, and real opportunities to advance. Culture That Lives Its Values Inclusion isn't just a buzzword - it's how we operate. You'll be seen, heard, and supported to bring your full self to work. Thrive with Stability and Purpose With nearly 90 years of trusted service and continued growth, Fraser is a nonprofit where you can build a lasting, mission-driven career. Fraser is Minnesota's leader in autism, mental health, and disability services - and one of the few Certified Community Behavioral Health Clinics (CCBHCs) in the state. As a nonprofit organization, we provide integrated community behavioral healthcare that improves quality, accessibility, and coordination of care. We lead with compassion, innovate with purpose, and fight for inclusion - every single day. Ready to Build Something Bigger? Join Fraser. Grow with us. Make a difference. Because when you thrive, so does the world around you. Diversity, Inclusion, and Belonging: Fraser values a diverse staff to ensure the best outcomes for our diverse client base. We are committed to anti-racism at Fraser. Our anti-racism committee assesses, develops, and implements numerous initiatives ranging from recruiting and retaining diverse staff to staff training and more. Fraser is an Affirmative Action and Equal Opportunity Employer. This position will be posted at ****************************** until filled. You must apply online here to be formally considered. If you are having trouble applying or have questions, please contact Fraser HR at ****************** or ************. If you have successfully submitted your application, you will get a confirmation email. If you do not receive the confirmation email, please check your junk/spam folders; then contact us as we may not have received your application. Thank you for considering Fraser!
    $105k-115k yearly Easy Apply 29d ago
  • Clinical Project Manager

    ZP Group 4.0company rating

    Clinical research coordinator job in Plymouth, MN

    Piper Companies is seeking a Clinical Project Manager to join a leading organization in the medical device industry for a 12-month contract position based onsite in Plymouth, MN (4 days per week). The Clinical Project Manager will oversee clinical study execution, manage budgets, and ensure compliance with regulatory standards, with a strong preference for experience in cardiovascular medical devices. Responsibilities of the Clinical Project Manager include: * Manage clinical study timelines and budgets, including vendor selection and contract oversight. * Facilitate communication among cross-functional teams (R&D, Regulatory, Marketing) and investigational sites. * Oversee regulatory submissions and ensure compliance with ISO and local regulations. * Provide input on protocol design, case report forms, and monitoring plans. * Coordinate investigator meetings, steering committees, and study-specific training for internal and site personnel. Qualifications for the Clinical Project Manager include: * Minimum of a Bachelor's degree in health sciences or related field. * At least 2 years of clinical project management experience; cardiovascular or cardiology device experience strongly preferred. * Proven ability to manage study budgets and timelines effectively. * Strong knowledge of ISO standards and clinical trial regulations. * Excellent communication, organizational, and leadership skills; proficiency in project management tools and Microsoft Office Suite. Compensation for the Clinical Project Manager: · * Salary: $125,000-$145,000/year (USD) * Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K. This job opens for applications on 12/17/25. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: clinical project management, clinical trials, medical device, cardiology, GCP, ISO compliance, regulatory submissions, budgeting, vendor management, protocol design, cross-functional collaboration, project timelines, investigator meetings, clinical operations. #LI-MB1 #LI-ONSITE
    $125k-145k yearly 11d ago
  • Clinical Research Director - Saint Paul

    On Time Talent Solutions

    Clinical research coordinator job in Saint Paul, MN

    Clinical Research Director Saint Paul, Minnesota St. Paul is the second city that forms Minnesota’s Twin Cities. As a large business hub in the upper Midwest, the St. Paul area is home to headquarters of many healthcare giants including Mayo Clinic, Ecolab, Allina and Essentia Health. Whether you are looking to relocate or are a current resident, job opportunities in St. Paul are abundant On Time Talent Solutions is seeking a Clinical Research Director interested in overseeing, leading, and managing cross\-functional team resources and external service providers. Clinical Research Director Responsibilities: Work with research leadership to develop clinical research strategic plans and objectives Help develop best practices, methods, techniques, and operational standards for clinical research coordination at Nemours Collaborate with Quality Assurance to develop quality plans for the conduct of clinical trials at Nemours Develop, update, and maintain SOP’s for clinical research across all sites Ensure federal regulations are followed and serve as subject matter expert for the submission of IND’s, and IDE’s at Nemours Track, report, and review study quality metrics and identifies activities warranted to meet trial goals and timelines Supervise clinical research core managers and leads across the Nemours enterprise Write, prepare, and\/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical documents Identify, qualify, audit, and manage all external vendors.. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives. Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed. Responsible for ensuring the trial is “audit ready” at all times. Clinical Research Director Qualifications: Bachelor's degree required; Master's degree preferred 5+ years supervising clinical research teams RN Required Familiarity with IND’s and IDE’s Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices Ability to Work collaboratively with cross functional internal groups\/teams Ability to create and manage internal and external budgets for research protocols Experience with developing systems to manage\/track productivity of clinical research functions "}}],"is Mobile":false,"iframe":"true","job Type":"Contract","apply Name":"Apply Now","zsoid":"461622380","FontFamily":"PuviRegular","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Medical"},{"field Label":"City","uitype":1,"value":"Saint Paul"},{"field Label":"State\/Province","uitype":1,"value":"Minnesota"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"55101"}],"header Name":"Clinical Research Director \- Saint Paul","widget Id":"3**********0072311","is JobBoard":"false","user Id":"3**********1132001","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"3**********8261302","FontSize":"15","location":"Saint Paul","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}
    $75k-121k yearly est. 60d+ ago
  • Clinical Evaluation, Project Manager - Clinical Scientist

    Abbott Laboratories 4.7company rating

    Clinical research coordinator job in Maple Grove, MN

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: The function of a Clinical Evaluation Project Manager supporting our Structural Heart Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (2016)requirements (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745. The CER PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, and CER). As such, this person has oversight of one or more medical writers guiding the development, or update, of CERs and CER-related documents. In addition, the CER PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. Moreover, the CER PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use. The CER PM will sit on core team product development, CER-related SOP development and revision, and interact with regulatory agencies' representatives as needed. The role of PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle. The position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations. Main Responsibilities: Manage medical writers' efforts in writing and editing of scientific content of deliverables, and the timelines of these documents Creates, manages, or participates in timelines of deliverables by using appropriate project management tools. Clearly and timely communicates the timelines, project risks, and risk mitigation strategies with cross functional teams and medical writers Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables. Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers). Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development teams and sustaining teams. Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics. Function independently as a decision-maker on CER-related regulatory issues and must assure that deadlines are met. Execute projects within budgetary guidelines. Required Qualifications: Associates Degree (± 13 years) Minimum 7 years Preferred Qualifications: A college degree (Bachelor's); in the life sciences (nursing, medicine, biomedical engineering) Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485 Effective written, verbal and presentation skills in the area of technical/clinical applications Strong command of medical and surgical terminology Project management and/or management of people experience Demonstrated ability to identify and adapt to shifting priorities and competing demands Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time Post graduate degree (Masters or Doctorate) preferred in the life sciences (nursing, medicine, biomedical engineering Experience in structural heart / structural intervention devices Certification is a plus (e.g., RAC and PMP) MD / PhD/RN/Pharm D with good written skills The base pay for this position is $86,700.00 - $173,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Regulatory OperationsDIVISION:MD Medical DevicesLOCATION:United States > Santa Clara : Building A - SCADDITIONAL LOCATIONS:United States > Maple Grove : 6820 Wedgwood Road N.WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
    $86.7k-173.3k yearly Auto-Apply 19d ago
  • Clinical Trial Manager - Central Midwest

    Heartflow 4.2company rating

    Clinical research coordinator job in Minneapolis, MN

    Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide. The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture. Job Responsibilities: Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans Participates in and leads process improvement activities within the department and cross functionally, including SOP development Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc. Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management Perform other duties as required for successfully completing studies, as necessary Skills Needed: Ability to work in a smaller team environment with a willing, all hands on deck attitude Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations Excellent written and oral English communication skills required Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint Educational Requirements & Work Experience: Bachelor's degree in science or health related field Demonstrated 5 years minimum relevant experience required Experience in cardiovascular medical device clinical research a plus Travel required: up to 25% A reasonable estimate of the base salary compensation range is $95,000 to $125,000 and cash bonus. #LI-IB1 Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination. Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals. Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at *********************************
    $95k-125k yearly Auto-Apply 50d ago
  • Senior Clinical Validation Project Manager

    Canon Medical Informatics

    Clinical research coordinator job in Minnetonka, MN

    We are looking for a driven Senior Clinical Validation Project Manager to join our team at Canon Medical Informatics! In this role you will oversee the design and execution of high-impact clinical validation studies for Canon Medical informatics' flagship SaMD platform. You will architect multi-site research programs, curate and qualify medical imaging datasets, and produce submission-grade scientific/clinical evidence to accelerate time-to-market for AI/ML-enabled features. You will work cross functionally to create and refine protocols, and align regulatory strategy to deliver compliant, audit-ready results. RESPONSIBILITIES Program & Project Management Lead the full lifecycle of clinical validation programs, from proposal and feasibility assessment through protocol design, execution, analysis, and delivery of regulatory-grade evidence for submissions (e.g., FDA 510(k)/CE marking) Build and execute project plans (scope, milestones, deliverables, timelines); proactively removing roadblocks Manage risk registers, escalations, and dependencies Conduct kickoff meetings, weekly status reports, retrospective meetings, and process improvement cycles Maintain documentation for agendas, meeting minutes, action items, decision logs, and version-controlled study materials Provide clear communication with stakeholders across Product, Regulatory and Engineering teams Data Management & Analysis Source, contract, catalog, de-identify, and curate heterogeneous datasets (≥1,000 cases/year) Maintain a centralized dataset library with traceability, auditability, and access control Perform data selection and readiness checks: filter datasets to meet study criteria, run subgroup analyses, and generate descriptive statistics on data distributions Site Liaison & Enablement Identify, evaluate, and onboard external clinical sites and principal investigators Collaborate with Legal/Procurement Teams to draft agreements (e.g., SOWs, data-use, BAAs) Conduct onsite and virtual visits; ensure timely data returns Develop and deliver training materials, onboard radiologists and annotators Oversee annotation workflows, quality checks, and adjudication processes Prepare infrastructure (hardware/cloud), install/configure study software, and provide operational support Provide ongoing support, troubleshooting, and feedback loops with site teams Study Design & Execution (Regulatory Documentation) Drive the creation, iteration, and refinement of study designs: partner with subject-matter experts, statisticians, and product/regulatory leads to shape initial proposals into finalized, approved study protocols Scope and manage study budgets, ensuring alignment with project objectives and regulatory expectations Collaborate with statisticians during study execution for formal performance analysis (e.g., accuracy/sensitivity/specificity, comparing ground-truth annotations to device outputs) Draft and refine validation reports and supporting evidence for 510(k)/CE submissions REQUIRED EDUCATION AND SKILLS Required 5+ years of experience in clinical validation, clinical research operations, or regulated software/medical-device programs Demonstrated success running multi-site clinical studies and delivering submission-ready evidence Strong data operations skills (Excel, QC pipelines, descriptive statistics); comfort with hardware/cloud setups Experienced with keeping meticulous documentation of protocols, reports, and stakeholder communications Familiarity with regulatory pathways (e.g., 510(k)/CE) and clinical research best practices Preferred Proficient in clinical research best practices, scientific literature review, and regulatory strategy, especially in the context of AI/ML-enabled imaging platforms (ex. Vitrea) Proficient in regulatory pathways and strategy for AI/ML-enabled imaging platforms, coupled with expertise in clinical research best practices and scientific literature review JOB COMPETENCIES Project Management - Establishes project goals, milestones, and procedures, defines roles and responsibilities, acquires project resources, coordinates projects throughout company, monitors project progress, manages multiple projects. Communication - Communicates well both verbally and in writing, creates accurate and punctual reports, delivers presentations, shares information and ideas with others, has good listening skills. Customer Focus - Builds customer confidence, is committed to increasing customer satisfaction, sets achievable customer expectations, assumes responsibility for solving customer problems, ensures commitments to customers are met, solicits opinions and ideas from customers, responds to internal customers. Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs. Meeting Management - Holds appropriate number of meetings, develops a meeting agenda, sets clear goals for meetings, involves appropriate people, encourages and balances input. COMPANY OVERVIEW At Canon Medical Informatics (formerly Vital Images, Inc.), what we do matters. This is at the heart of every product we develop, every service we provide, and especially each member of our team. As part of Canon Medical Systems Corporation, we lead the industry with the latest health imaging informatics solutions. Our products handle millions of medical images and health records a day across the world. Canon Medical Informatics experiences the best of both worlds with a dynamic and collaborative environment, casual culture, and agility of a mid-sized company, while having the support and resources of Canon Medical Systems Corporate, our parent company. Our offices are based in Minnetonka, Minnesota; Waterloo, Ontario; Copenhagen, Denmark; The Netherlands; and Beijing, China. We value our team's innovation, enthusiasm, and dedication to help improve the lives of patients. Do you want to be part of a passionate team that believes what we do matters? Then a career with Canon Medical Informatics might be right for you! COMPANY VALUES Unity, Courage, Tenacity, Teamwork, and Excellence COMPENSATION $91,130 - $136,700 (dependent on experience) WHAT WE OFFER YOU Canon Medical Informatics offers a dynamic workplace, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you'll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn't sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. Our team loves what we do and has fun doing it together. We look forward to receiving an application from you. Canon Medical Informatics is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
    $91.1k-136.7k yearly 60d+ ago
  • Senior Clinical Validation Project Manager

    Vital Images, Inc. 4.3company rating

    Clinical research coordinator job in Minnetonka, MN

    We are looking for a driven Senior Clinical Validation Project Manager to join our team at Canon Medical Informatics! In this role you will oversee the design and execution of high-impact clinical validation studies for Canon Medical informatics' flagship SaMD platform. You will architect multi-site research programs, curate and qualify medical imaging datasets, and produce submission-grade scientific/clinical evidence to accelerate time-to-market for AI/ML-enabled features. You will work cross functionally to create and refine protocols, and align regulatory strategy to deliver compliant, audit-ready results. RESPONSIBILITIES Program & Project Management * Lead the full lifecycle of clinical validation programs, from proposal and feasibility assessment through protocol design, execution, analysis, and delivery of regulatory-grade evidence for submissions (e.g., FDA 510(k)/CE marking) * Build and execute project plans (scope, milestones, deliverables, timelines); proactively removing roadblocks * Manage risk registers, escalations, and dependencies * Conduct kickoff meetings, weekly status reports, retrospective meetings, and process improvement cycles * Maintain documentation for agendas, meeting minutes, action items, decision logs, and version-controlled study materials * Provide clear communication with stakeholders across Product, Regulatory and Engineering teams Data Management & Analysis * Source, contract, catalog, de-identify, and curate heterogeneous datasets (≥1,000 cases/year) * Maintain a centralized dataset library with traceability, auditability, and access control * Perform data selection and readiness checks: filter datasets to meet study criteria, run subgroup analyses, and generate descriptive statistics on data distributions Site Liaison & Enablement * Identify, evaluate, and onboard external clinical sites and principal investigators * Collaborate with Legal/Procurement Teams to draft agreements (e.g., SOWs, data-use, BAAs) * Conduct onsite and virtual visits; ensure timely data returns * Develop and deliver training materials, onboard radiologists and annotators * Oversee annotation workflows, quality checks, and adjudication processes * Prepare infrastructure (hardware/cloud), install/configure study software, and provide operational support * Provide ongoing support, troubleshooting, and feedback loops with site teams Study Design & Execution (Regulatory Documentation) * Drive the creation, iteration, and refinement of study designs: partner with subject-matter experts, statisticians, and product/regulatory leads to shape initial proposals into finalized, approved study protocols * Scope and manage study budgets, ensuring alignment with project objectives and regulatory expectations * Collaborate with statisticians during study execution for formal performance analysis (e.g., accuracy/sensitivity/specificity, comparing ground-truth annotations to device outputs) * Draft and refine validation reports and supporting evidence for 510(k)/CE submissions REQUIRED EDUCATION AND SKILLS Required * 5+ years of experience in clinical validation, clinical research operations, or regulated software/medical-device programs * Demonstrated success running multi-site clinical studies and delivering submission-ready evidence * Strong data operations skills (Excel, QC pipelines, descriptive statistics); comfort with hardware/cloud setups * Experienced with keeping meticulous documentation of protocols, reports, and stakeholder communications * Familiarity with regulatory pathways (e.g., 510(k)/CE) and clinical research best practices Preferred * Proficient in clinical research best practices, scientific literature review, and regulatory strategy, especially in the context of AI/ML-enabled imaging platforms (ex. Vitrea) * Proficient in regulatory pathways and strategy for AI/ML-enabled imaging platforms, coupled with expertise in clinical research best practices and scientific literature review JOB COMPETENCIES * Project Management - Establishes project goals, milestones, and procedures, defines roles and responsibilities, acquires project resources, coordinates projects throughout company, monitors project progress, manages multiple projects. * Communication - Communicates well both verbally and in writing, creates accurate and punctual reports, delivers presentations, shares information and ideas with others, has good listening skills. * Customer Focus - Builds customer confidence, is committed to increasing customer satisfaction, sets achievable customer expectations, assumes responsibility for solving customer problems, ensures commitments to customers are met, solicits opinions and ideas from customers, responds to internal customers. * Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs. * Meeting Management - Holds appropriate number of meetings, develops a meeting agenda, sets clear goals for meetings, involves appropriate people, encourages and balances input. COMPANY OVERVIEW At Canon Medical Informatics (formerly Vital Images, Inc.), what we do matters. This is at the heart of every product we develop, every service we provide, and especially each member of our team. As part of Canon Medical Systems Corporation, we lead the industry with the latest health imaging informatics solutions. Our products handle millions of medical images and health records a day across the world. Canon Medical Informatics experiences the best of both worlds with a dynamic and collaborative environment, casual culture, and agility of a mid-sized company, while having the support and resources of Canon Medical Systems Corporate, our parent company. Our offices are based in Minnetonka, Minnesota; Waterloo, Ontario; Copenhagen, Denmark; The Netherlands; and Beijing, China. We value our team's innovation, enthusiasm, and dedication to help improve the lives of patients. Do you want to be part of a passionate team that believes what we do matters? Then a career with Canon Medical Informatics might be right for you! COMPANY VALUES Unity, Courage, Tenacity, Teamwork, and Excellence COMPENSATION $91,130 - $136,700 (dependent on experience) WHAT WE OFFER YOU Canon Medical Informatics offers a dynamic workplace, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you'll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn't sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. Our team loves what we do and has fun doing it together. We look forward to receiving an application from you. Canon Medical Informatics is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
    $91.1k-136.7k yearly 60d+ ago
  • Clinical Research Scholar, Center for Coronary Artery Disease

    Minneapolis Heart Institute Foundation 3.5company rating

    Clinical research coordinator job in Minneapolis, MN

    Job DescriptionAn established cardiology research team (Principal investigator - PI: Emmanouil Brilakis, MD, PhD) invites applications for a full-time research scholarfor a period of at least two years. Our research team is based at the Minneapolis Heart Institute Foundation (MHIF) in Minneapolis, Minnesota, USA and works in collaboration with the Minneapolis Heart Institute at Abbott Northwestern Hospital (MHI), part of the Allina Health System. The team is conducting several clinical studies, including the PROGRESS-CTO registry, PROGRESS Bifurcation Registry, the PROGRESS Complications Registry and the REBIRTH Trial. We are seeking a highly motivated researcher who is interested in studying coronary artery disease and contributing to progress in the field. The Research Scholar will be responsible for conducting clinical research studies and using good clinical practice guidelines under the supervision of the PI. The Research Scholar will develop significant expertise in designing and executing clinical studies, both prospective and retrospective, single-center and multi-center. Moreover, they will acquire significant experience in medical writing and the publication process. The Research Scholar will also gain experience in preparing and submitting abstracts and challenging cases to scientific congresses, and in presenting their work in oral and/ or poster formats. Previous and current Research Scholars in the program have been very successful in publishing and securing clinical residency/fellowship training positions. This research position has no patient care responsibilities. Duration : We will assist the chosen scholar in the acquisition of a research visa. We are looking for a minimum commitment of 2 years full-time to optimize this training, education, research and publication experience. Primary Responsibilities: 1. Initial research relates to chronic total occlusions/ coronary bifurcations/ cardiac catheterization and PCI complications, comparison of treatment/procedural strategies and outcomes. The scholars will evaluate the pathogenesis of the various components of complex coronary artery disease, as well as innovative treatments. The incumbent will also investigate and contribute actively to scientific work in the areas of complex coronary artery disease such as saphenous vein graft disease, complex high-risk indicated procedures/ percutaneous coronary intervention procedures and comparison of arterial access for percutaneous procedures. 2. Participate in the development and execution of the ongoing investigator-initiated trials at the Minneapolis Heart Institute Foundation. The scholars will be involved in development of creation of study databases, collaboration with research staff at the coordinating center as well as sites in collecting and analyzing study data, as well as recruitment of study participants. 3. Support “Get with the guidelines”: Creating systems and process so all coronary artery disease patients are treated according to best practice guidelines. Investigate guideline adherence and discover barriers that limit coronary artery disease patients from receiving standard of care. Design, develop, and implement novel patient care pathways leading to optimal guideline-based care. 4. Help expand the delivery of high-quality, state-of-the-art care for patients with coronary artery disease. Greatly improve coronary artery disease treatment outcomes by expanding treatment indications. Discover disease related mechanisms and early intervention methods to prevent advancing coronary artery disease. Drive early adoption of innovative therapies 5. Innovate novel education methods to disseminate best in class clinical care models Create a model where all physician/providers deliver optimal coronary artery disease care. Educate consumers and patients on seeking the state-of-the-art care in the prevention, screening, diagnosis, and treatment of coronary artery disease. Qualifications : Medical degree with track record of excellence required Interest in coronary artery disease, exposure to cardiology/interventional cardiology specialty training in general cardiology and/or interventional cardiology is preferred Knowledge of basic statistical methods Skilled and versatile with computer technology including the Microsoft suite including Excel, comfort with databases and preferably some website development skills Flexible and adaptable to work on a variety of studies and tasks Proficiency in English (verbal and written) Salary : The Research fellow will receive a full-time salary at the prevailing wage, $56,368 and employee benefits including medical, dental, life, short and long term disability, HSA with employer contributions, PTO, parental leave, tuition reimbursement, paid volunteer time, and 10 paid holidays. Include your CV and USMLE scores if completed and two letters of reference. For positions starting Spring of 2026, application timelines are as follows: Deadline for application submission: October 1, 2025 Interviews scheduled through October 31, 2025 Selected candidates will be notified on or before November 29, 2025 Applications will be accepted on a rolling basis and maybe considered for the following year or the year after.
    $51k-68k yearly est. 30d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in Inver Grove Heights, MN?

The average clinical research coordinator in Inver Grove Heights, MN earns between $33,000 and $69,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in Inver Grove Heights, MN

$48,000
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