Clinical research coordinator jobs in Saint Cloud, MN - 101 jobs

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.

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 Clinical Trial Manager will lead the design, planning, execution, and oversight of global clinical studies for the Renal Denervation portfolio. This individual will manage cross-functional clinical teams to support business objectives related to both product development and commercialization. The incumbent will bring deep expertise in clinical trial operations, a strong understanding of regulatory requirements, and technical knowledge specific to the relevant therapeutic area. Visa sponsorship: Boston Scientific will not offer sponsorship or take sponsorship of an employment visa at this time. Work mode: This is a hybrid position (in office minimum three days per week) to be located in Arbor Lakes, MN. Your responsibilities will include: Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies. Writes study protocols, protocol amendments, informed consents, project plans and timelines; stays abreast of current clinical practice by analyzing scientific data from literature and publications. Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. Tracks development of and collaborates with the study team on all internal and external project materials, processes, manuals, plans, committees, vendors, study systems and all sponsor required regulatory submissions. Ensures the study team maintains a continuous state of audit readiness. In collaboration with the study team, leads the proactive identification, assessment, and management of clinical study risks and emerging trends. Facilitates communication between Sales & Marketing, Medical Affairs, Regulatory Affairs, R&D, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior management. Interacts with regulatory agencies as needed and will use their scientific knowledge to provide directives to staff as well as study sites. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings. Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Ethics Committees, etc. Required qualifications : Minimum 5 years related work experience with Bachelor's degree or 3 years with Master's degree Proven Clinical trial experience required (Sponsor or CRO) Advanced knowledge of Good Clinical Practices (GCP), ISO 14155 and FDA regulations governing the conduct of clinical trials Prior or current experience working with external vendors and Contract Research Organizations (CRO) Preferred qualifications: Current or previous experience with medical device clinical trials Current or previous experience with cardiovascular therapeutic areas Proven ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships Requisition ID: 620105 Minimum Salary: $ 99100 Maximum Salary: $ 188300 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. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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

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 ************

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. 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 $90,000.00 - $180,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call ************ or email ******************

Job Description About the role: The Senior Clinical Research Specialist will join the Urology Biostatistics and Real World Evidence team. This role supports key commercialized products by developing and executing clinical research activities from real-world data sources and driving long-term evidence strategies. This role creates and maintains all documentation pertaining to clinical research activities, designs studies utilizing these non-clinical trial data sources, builds cohorts through data element identification and mapping, and collaborates cross-functionally to ensure cohesiveness and appropriateness of research scope. Responsibilities will include: Support strategic growth of the team's Real-World Evidence (RWE) capabilities and demonstrate ROI in the use of these new clinical data sources Plan and execute feasibility and analysis of the Urology RWE studies programmatically utilizing data science techniques and contribute to post-market documentation, publications, and other documents as needed. Design studies utilizing administrative claims, Electronic Health Records (EHR), and other RWE data sources by applying clinical research methodologies (e.g., research question development, population inclusion/exclusion, reduction of bias, etc.) Develop coding definitions utilizing reimbursement code sets (ICD-10-CM, ICD-10-PCS, CPT, etc.) and medical terminologies (SNOMED, LOINC, RxNorm, etc.) for populations, outcomes, and co-variates of interest in the Urology space. Collaborate cross-functionally with Clinical Strategy, Scientific Communication, Biostatistics, Medical Safety, Legal, and Compliance to design and run RWE studies. Manage internal and external project materials and timelines. Participate as a key team member on process development and improvement efforts to meet Urology VIP goals. Required Qualifications: Minimum of a Bachelor's Degree in a related field and 4 years of related work experience (including data analytics, data management, health economics, medical affairs, clinical risk, clinical trial operations, clinical safety, quality assurance or regulatory affairs) or advanced degree (PhD, research-based MS, MD, RN/DVM) in a related field with 4+ years of related work experience Expertise in leveraging medical coding systems and terminologies for research applications (ICD-9/10, CPT, SNOMED, LOINC, RxNorm, etc.) Proven experience using Python, R, other software for exploring, structuring, and analyzing data sets, relational data modeling and querying expertise (SQL) Ability to work in a team environment and possess clear, concise communication skills - both written and verbal Preferred Qualifications: Preferred medical device or clinical experience in Urology Prior or current experience in retrospective research design with Real World data including claims data inclusive of Charge Master Data and/or Electronic Health Record (EHR) data Proven scientific writing experience Proven Physician-facing experience

Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. Benefits Highlights * Medical: Multiple plan options. * Dental: Delta Dental or reimbursement account for flexible coverage. * Vision: Affordable plan with national network. * Pre-Tax Savings: HSA and FSAs for eligible expenses. * Retirement: Competitive retirement package to secure your future. Responsibilities Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience. As a Clinical Research Coordinator, you will: * Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. * Collaborate with research team to assess feasibility and management of research protocols. * Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports. * Screen, enroll, and recruit research participants. * Coordinate schedules and monitor research activities and subject participation. * Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately. * Manage, monitor, and report research data to maintain quality and compliance. * Provide education/training for others within the department. * Perform administrative and regulatory duties related to the study as appropriate. * Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. * Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. * Participate in other protocol development activities and execute other assignments as warranted and assigned. * Some travel may be required. This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus. Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension. During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. Qualifications * HS Diploma with at least 5 years of clinical research coordination/related experience OR * Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR * Associate's in Clinical Research from an accredited academic institution without experience OR * Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. * Experience should be in the clinical setting or related experience. Additional Qualifications * Graduate or diploma from a study coordinator training program is preferred. * One year of clinical research experience is preferred. * Medical terminology course is preferred. Exemption Status Nonexempt Compensation Detail $27.44 - $41.16 / hour Benefits Eligible Yes Schedule Full Time Hours/Pay Period 80 Schedule Details Day shift; Monday - Friday Weekend Schedule N/A International Assignment No Site Description Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. Equal Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the 'EOE is the Law'. Mayo Clinic participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. Recruiter Chad Musolf

Salary range: $52,000-$67,000 Full-time. Exempt, salaried. The Clinical Study and Biospecimen Coordinator (CSC) plays a key role in supporting the operational execution of Vyriad's Phase 1/2 clinical trials and will be responsible for managing biospecimens used for exploratory and translational research. This position is critical in coordinating supply of test kits and receipt of clinical samples, ensuring high-quality sample collection, processing, shipping, tracking, and documentation across a network of clinical sites and research laboratories. The candidate will maintain sample inventory, receive data reports and be responsible for data entry and analysis. The CSC will collaborate closely with Clinical Operations, Translational Science, external vendors, and clinical sites to maintain compliance, ensure protocol adherence, and facilitate timely generation of high-quality data. Supervisory Responsibilities None Duties and Responsibilities Clinical Study Coordination * Assist in day-to-day oversight of multiple ongoing Phase 1/2 trials, supporting study start-up, conduct, and close-out activities * Maintain and update study trackers, timelines, enrollment metrics, and essential documentation * Support preparation, review, and approval of study materials (e.g., site training slides, study manuals, sample handling guides, visit worksheets) * Coordinate and document study team meetings, vendor meetings, and cross-functional check-ins * Monitor site performance metrics and assist with issue identification, follow-up, and escalation * Work with CROs, central labs, and vendors to ensure deliverables are met according to the study plan * Support data review activities such as data listings checks, lab reports reconciliation, and query management Biospecimen & Exploratory Testing Management * Serve as the primary operational contact for test kits, biospecimen collection, processing, and logistics across clinical sites * Ensure all sample-related procedures follow protocol requirements, sample manuals, IATA regulations, and GCP guidelines * Track and log daily/weekly sample collections, deviations, processing results, and shipments using internal LIMS system and eCRF * Coordinate shipment logistics including temperature-controlled handling, courier pickup scheduling, and documentation * Receives correlative research data reports and ensures data entry and analysis * Work closely with patient management and operations teams at clinical sites to align sample workflows with central lab biomarker analysis needs * Maintain complete, accurate sample chain-of-custody records and promptly address discrepancies * Support biorepository activities such as inventory reviews, sample labeling audits, and sample reconciliations * Assist in onboarding and training clinical sites on biospecimen handling procedures, including updates to sample manuals and shipping instructions Additional duties as assigned. Education and Experience * Bachelor's degree in Life Sciences or related field; Masters degree a plus but not required * 2+ years of experience in clinical research or clinical operations, ideally within a biotech or early-phase trial environment * Prior hands-on experience with biomarker operations (eg. biospecimen handling, central lab coordination, translational research workflows, etc.) strongly preferred * Familiarity with oncology Phase 1/2 study designs, PK/PD sampling and data evaluation desirable Required skills and/or qualifications * Working knowledge of GCP/ICH guidelines, clinical trial conduct, and regulatory documentation * Strong understanding of specimen types (e.g., whole blood, serum, plasma, PBMCs, tumor tissue) and proper collection/processing requirements * Highly organized with the ability to manage multiple tasks simultaneously across studies * Strong communication and interpersonal skills for effective collaboration with internal central lab staff, clinical operations team members, vendors, and site staff * Detail oriented with excellent documentation, tracking, and problem-solving abilities * Ability to adapt quickly and work effectively in a fast-paced, dynamic environment. * Strong problem-solving skills with the ability to navigate ambiguous situations and make sound decisions. * Proficiency with EDC systems, LIMS/sample-tracking tools, and Microsoft Office tools Physical Requirements * Prolonged periods of sitting at a desk and working on a computer. * Must be able to lift up to 15 pounds at times. Benefits * Group Healthcare Plan, including company paid dental and vision. * Short- and long-term disability, life and AD&G insurance. * Simple IRA with employer match * Educational assistance program * Holiday and PTO

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: • Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable. • Assists Study Directors on select projects under the direction and review of the Study Director team. • Assists in collection, documentation and analysis of pre-clinical data. • Assists in the coordination of study tasks from pre-study initiation to study completion. • Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed. • Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review. • Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct. • Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies. • Assists with data collection, database entry and generating/tabulating data. • Distributes study related documents, i.e. copies of study data sheets • Creates documentation per SOP to assist with test/control article accountability. • May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation. • Assists with generating technical reports as directed and assist in identifying issues and recommend solutions. • Maintains client inventory and is required to be familiar with internal and competitor products. • Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned. • Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations. • Other duties as assigned. Qualifications & Technical Competencies: • One year experience in an administrative position desirable, preferably with an emphasis in a laboratory setting. • Working knowledge of word processing and spreadsheet software. • Requires a minimum of an Associate degree, preferably in a scientific discipline. Working Conditions: • While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens. • The noise level in the work environment is usually moderate. • While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds. • Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination. Pay Range Minimum: $17.79 Pay Range Target: $26.00 Pay Frequency: Hourly 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.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a Research Coordinator I to implement a portfolio of clinical research trials and projects related to ASD. The Clinical Research Coordinator I will work under the supervision of the Senior Clinical Research Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinical research including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines. Job Summary Summary Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions * Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. * Recruiting patients for clinical trials, conducts phone interviews. * Verifies the accuracy of study forms and updates them per protocol. * Prepares data for analysis and data entry. * Documents patient visits and procedures. * Assists with regulatory binders and QA/QC Procedures. * Assists with interviewing study subjects. * Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Remote Type Onsite Work Location 1 Maguire Road Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience. As a Clinical Research Coordinator, you will: Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborate with research team to assess feasibility and management of research protocols. Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports. Screen, enroll, and recruit research participants. Coordinate schedules and monitor research activities and subject participation. Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately. Manage, monitor, and report research data to maintain quality and compliance. Provide education/training for others within the department. Perform administrative and regulatory duties related to the study as appropriate. Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participate in other protocol development activities and execute other assignments as warranted and assigned. *Some travel may be required. **This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus.** **Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.** **During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. ** HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Experience should be in the clinical setting or related experience. Additional Qualifications Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.

* Candidates must be a Minnesota resident. Job Status: Full-time (Monday - Friday) We are seeking a motivated and talented Clinical Research Coordinator to join our busy, fast paced specialty office at Twin Cities Spine Center (TC Spine). Come be a part in our patient's lives and work for an organization that has consistently been named one of the area's Top Workplaces. The Research Coordinator is a critical role responsible for managing the activities of ongoing research projects and studies that support Twin Cities Spine Center's (TC Spine) research and fellowship programs. Working closely with the Research Director and staff, Surgeon Investigators, and Fellows, this role assists with the development of research studies and is responsible for managing multiple research projects. The Research Coordinator duties include study material preparation, data management, regulatory document preparation, and project coordination in accordance with established protocols, federal and state regulations, and Institutional Review Board (IRB) requirements. The Research Coordinator also plays a key role in scholarly activity by co-authoring abstracts and manuscripts for submission to conferences and peer-reviewed medical journals. In addition, this role manages research and quality data that supports organizational Quality Assurance and continuous improvement initiatives. Job Responsibilities: * Co-author and submit abstracts and manuscripts to conferences and peer-reviewed medical journals * Develop and write research protocols, informed consent forms, grants, and other study related documents * Prepare and submit Institutional Review Board (IRB) documentation (initial approvals, continuing reviews, adverse event reports, and study closure reports) * Maintain regulatory binders, source documentation and appropriate forms per protocol * Perform data abstraction for research studies * Ensure the accuracy, completeness, and integrity of data * Maintain research database including validity and consistency assessments * Learn and implement new technology and software for research (e.g., Outcomes Based Electronic Research Database - OBERD) * Plan project timelines, milestones and deliverables, then implement and track project progress * Communicate project status to the Research Director, surgeon investigators and Fellows (study advances or delays with approvals, data collection, patient enrollment, etc.) * Maintain regular communication with study participants and address any concerns * Ensure research studies are conducted ethically and in compliance with Federal and state laws * Respect and protect confidentiality of subjects (HIPAA) * Screen and enroll study participants (obtain and document Informed Consent) * Develop and implement strategies for participant recruitment and retention * Attend weekly Monday conferences in-person * Work with the other Research Coordinators, the Research Director, surgeon investigators, and Fellows to ensure projects are completed Job Requirements: * Master of Science or Arts Degree or higher, required * Requires a minimum of 5 years' experience in clinical research * Proficient with healthcare software (Epic, NextGen) for research purposes * Proficient with IRB processes and compliance rules pertaining to research, confidentiality, and HIPAA * Working knowledge of US Food and Drug Administration (FDA) and state laws and regulations pertaining to clinical trials * Advanced knowledge of Microsoft Office Suite * Ability to adapt to different working styles and effectively communicate with staff and providers using excellent interpersonal and verbal/written communication skills * Ability to pay attention to the smallest details involved in taking service to the next level to deliver high-quality customer service to external/internal customers and communicate with knowledge and compassion * Ability to effectively manage and prioritize multiple tasks, frequent interruptions, and details with accuracy * Ability to resolve basic service recovery issues and understand when to escalate to the next level * Ability to work with people of all ages, ethnicities, and backgrounds Benefits: * Medical, Dental, and Vision Insurance * Group Life and AD&D coverage * Company Paid Short and Long Term Disability coverage * Flexible Spending and Health Saving Account options * 401(k) plan through salary deferrals * PTO and Paid Holidays The above description is intended to provide a general outline of some of the basic job requirements and responsibilities and is not all inclusive. Job responsibilities, required skills, and working conditions are also subject to change from time to time. Twin Cities Spine Center is an Equal Employment Opportunity Employer, and provides reasonable accommodation to qualified disabled individuals in accordance with applicable federal and state law.

Join our dynamic team in Mounds View, MN, where innovation meets excellence in clinical research. We are seeking a highly motivated individual to oversee, design, and develop clinical evaluation research studies. This role offers the opportunity to work full-time on-site in a collaborative and cutting-edge environment. Must Have Experience with CTMS and patient data and site management systems (i.E., Veeva Vault, RAD Rave, Oracle) Proficiency in Microsoft Office Applications Top 3 Candidate Experience Requirements Site management experience (site or sponsor) Knowledge/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP) Education and Experience Education Required: Bachelor's Degree (preferably in engineering, life sciences, or related medical/scientific field) Years of Experience Required: Minimum 2 years of experience Responsibilities Responsibilities may include the following and other duties may be assigned: Oversee, design, plan, and develop clinical evaluation research studies. Prepare and author protocols and patient record forms. Conduct registered and nonregistered clinical studies of products that satisfy a medical need and/or offer commercial potential. Oversee and interpret results of clinical investigations in preparation for new drug device or consumer applications. Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection. Career Stream This position typically involves responsibilities in a professional discipline or specialty. The role requires delivering and/or managing projects assigned and collaborating with other stakeholders to achieve desired results. You may act as a mentor to colleagues or direct the work of other lower-level professionals. Required Knowledge and Experience The position requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. A University Degree and a minimum of 2 years of relevant experience are required, or an advanced degree with 0 years of experience.

4050 Coon Rapids Blvd NW Coon Rapids, MN 55433-2522 Department: 16000480 AHCI Research Shift: Day (United States of America) Shift Length: 8 hour shift Hours Per Week: 40 Union Contract: Non-Union-NCT Weekend Rotation: None Job Summary: Bring your expertise to Allina Health by coordinating high‑quality care for patients in clinical research studies by ensuring standards are met, educating participants, and collaborating across disciplines to support safe, effective study outcomes. Join us today and make an impact on lives! Key Position Details: 1 FTE (40 hours per week) 8-hour day shift No weekends Job Description: Coordinates care for patients enrolled in clinical research studies in Health System. Under supervision of senior team members and Research Investigators, ensures research patient care needs meet standards. Coordinates research plan of care, provides education for patients enrolled in study and collaborates with other disciplines to provide direct patient care to study participants. Principle Responsibilities Ensure coordination of patient care in accordance with research protocol and regulatory requirements. Assist with providing protocol-specific education to investigators, nurses, pharmacy staff and any other staff directly supporting study protocol, to ensure accurate and safe administration of study treatments. Provide applicable sections of the study protocol to clinical staff to assist with training. Coordinate patient care throughout the research study and follow-up period, and ensure compliance with the study. Perform safety monitoring and clinical care in accordance with the protocol. Conduct ongoing patient evaluations (in collaboration with clinical team) to assess patients' treatment toxicity and response. Assist investigator in dose modifications according to the protocol. Instruct staff on side effect management in accordance with the research protocol. Perform data management in accordance with the research protocol. Maintain systems for appropriate identification, recruitment, consent, and enrollment/ randomization of eligible patients on clinical research studies. Assist with study start-up activities including but not limited to participating in pre-study visits, site initiation visits, protocol-specific training, and investigator meetings. Perform screening activities and determine patient eligibility, obtain informed consent, and enroll/ randomize patients into studies. Maintain communication appropriate for study patients' age and other special needs. Assist with training and mentoring of research and clinical staff for protocol specific procedures. Assist with orientation and mentoring of research staff including clinical research coordinators, and other research staff. Contribute to development of quality indicators, data collection, review and recommendations. Demonstrate ability to work collaboratively with other members of the team including investigators, research staff, and hospital/clinic and infusion center staff. Maintain accurate and complete research drug accountability. Maintain study drug inventories at research sites. Maintain accurate and complete study drug logs. Maintain temperature parameters for study drugs according to manufacturers' recommendations and sponsor requirements. Other duties as assigned. Required Qualifications Bachelor's degree from an accredited nursing program 2 to 5 years of experience in clinical practice and/or hospital experience in specialty Licenses/Certifications RN - MN Board of Nursing required upon hire BLS Tier 1 - Basic Life Support - Multisource required upon hire Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within (180 days) of hire (offered through Allina Health) Certification in nursing specialty preferred Physical Demands Sedentary: Lifting weight up to 10 lbs. occasionally, negligible weight frequently Pay Range Pay Range: $36.22 to $49.65 per hour The pay described reflects the base hiring pay range. Your starting rate would depend on a variety of factors including, but not limited to, your experience, education, and the union agreement (if applicable). Shift, weekend and/or other differentials may be available to increase your pay rate for certain shifts or work. Benefit Summary Allina Health believes the best way to provide safe and compassionate care for our patients is by nurturing the passion of those who care for them. That's why we devote extraordinary resources to help you grow and thrive - not only as a professional but also as a whole person. When you join our team, you have access to a wealth of valuable employee benefits that support the total well-being - mind, body, spirit and community - of you and your family members. Allina Health is all in on your well-being. Because well-being means something different to everyone, our award-winning program provides you with the resources you need to help you navigate your personal journey. This includes up to $100 in well-being dollars, dedicated well-being navigators, and many programs, activities, articles, videos, personal coaching and tools to support you on your journey. In addition, Allina Health offers employee resources groups (ERGs) -- voluntary, employee-led groups that serve as a resource for members and organizations by fostering a diverse, inclusive workplace aligned with the organization's mission, values, goals, business practices, and objectives. Allina Health also engages employees in various community involvement and volunteering events. Benefits include: Medical/Dental PTO/Time Away Retirement Savings Plans Life Insurance Short-term/Long-term Disability Voluntary Benefits (vision, legal, critical illness) Tuition Reimbursement or Continuing Medical Education as applicable Student Loan Support Benefits to navigate the Federal Public Service Loan Forgiveness Program Allina Health is a 501(c)(3) eligible employer *Benefit eligibility/offerings are determined by FTE and if you are represented by a union.

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: As a Project Manager within ICTx Clinical Data and Perfomance Reporting, you will play a critical role in driving data-informed decision-making across the CT/IHF and SHV/RDN Clinical Trials teams. You will be responsible for developing, automating, and maintaining clinical trial reports and performance dashboards, while also serving as a key technical resource for the Smartsheet platform. This role supports cross-functional collaboration to optimize operational efficiency and ensure timely and accurate insights that support strategic clinical goals. Work mode, and sponsorship: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. 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 the ICTx Clinical Affairs team in developing and maintaining current operational and performance metrics. * Develop and maintain clinical trial status reports and performance dashboards for CT/IHF and SHV/RDN Clinical Trials teams. * Provide training and technical support for Smartsheet, the core reporting platform. * Identify, propose, and implement automation opportunities within the reporting ecosystem. * Collaborate with cross-functional teams to validate data sources and ensure consistent reporting standards. * Deliver timely and audit-ready metrics and dashboards for review by internal stakeholders and senior leadership. Required qualifications: * Minimum Bachelor's degree in life sciences, data analytics, engineering, or a related field * Minimum of 7 years' experience in clinical research, project management, or reporting/analytics within healthcare or medical devices * Proven hands on experience with Smartsheet, Tableau, Power BI, Excel, and SQL * Strong analytical and data visualization skills with demonstrated experience creating clinical trial performance dashboards. * Proven and superior communication and stakeholder management skills, including experience translating complex data into clear insights for leadership * Proven understanding of the clinical trial lifecycle and regulatory/compliance requirements. Preferred qualifications: * Preferred Master's degree or PMP certification * Familiarity with clinical trial management systems (CTMS)and data governance standards * Prior experience implementing or supporting business intelligence tools in a regulated environment Requisition ID: 621954 Minimum Salary: $102100 Maximum Salary: $194000 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: Project Manager, Clinical Research, Medical Research, Performance Management, Medical Device, Technology, Healthcare, Human Resources

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 ********************************** ************

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

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: * Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable. * Assists Study Directors on select projects under the direction and review of the Study Director team. * Assists in collection, documentation and analysis of pre-clinical data. * Assists in the coordination of study tasks from pre-study initiation to study completion. * Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed. * Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review. * Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct. * Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies. * Assists with data collection, database entry and generating/tabulating data. * Distributes study related documents, i.e. copies of study data sheets * Creates documentation per SOP to assist with test/control article accountability. * May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation. * Assists with generating technical reports as directed and assist in identifying issues and recommend solutions. * Maintains client inventory and is required to be familiar with internal and competitor products. * Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned. * Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations. * Other duties as assigned. Qualifications & Technical Competencies: * One year experience in an administrative position desirable, preferably with an emphasis in a laboratory setting. * Working knowledge of word processing and spreadsheet software. * Requires a minimum of an Associate degree, preferably in a scientific discipline. Working Conditions: * While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens. * The noise level in the work environment is usually moderate. * While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds. * Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination. Pay Range Minimum: $17.79 Pay Range Target: $26.00 Pay Frequency: Hourly 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.

Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience. As a Clinical Research Coordinator, you will: Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborate with research team to assess feasibility and management of research protocols. Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports. Screen, enroll, and recruit research participants. Coordinate schedules and monitor research activities and subject participation. Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately. Manage, monitor, and report research data to maintain quality and compliance. Provide education/training for others within the department. Perform administrative and regulatory duties related to the study as appropriate. Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participate in other protocol development activities and execute other assignments as warranted and assigned. *Some travel may be required. **This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus.** **Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.** **During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. ** HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Experience should be in the clinical setting or related experience. Additional Qualifications Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.