• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations • Contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead • Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers • Contribute to the review and writing of clinical trial documents for CTR activities, and publications (as applicable) • Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings) • Support regulatory activities (preparation of meetings with regulatory agencies) • Produce training materials, share best practices and provide training to the broader clinical trial teams • Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others) • Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites) • Includes support for Case Report Form (CRF) development, and implementation of data capture tools • Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle • Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review • Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement • For all these tasks, work in close collaboration and alignment with clinical development lead • Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead

Principal Clinical Specialist, Coronary Renal Devernation - Portland, OR Remote Portland, Oregon, United States of America Full time R69865 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 We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. Bring your clinical talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career in clinical and sales support as we engineer the extraordinary and change lives. POSITION DESCRIPTION: Provide technical, educational and sales support to assist the district in meeting assigned Coronary Renal Denervation (CRDN) sales and customer service objectives with a heavy emphasis on supporting CathWorks FFRangio. CRDN seeks collaborative candidates who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. We look for candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action. This position will be the customer's first line contact for the CRDN daily operations at assigned accounts. ** This position is a field-based and regional role. Must be able to travel up to 70% of the time within regions** POSTION RESPONSIBILITIES: - Sales Support for CRDN business units and will assist with the implementation of the sales strategy of the remaining CRDN business units. - Support the regional CRDN sales strategy as set forth by the National Sales Director; working with sales representatives and managers of all business units to achieve business plans. - The Clinical Specialist Manager (CSM) and National Sales Director may include primary responsibility for sales if no other sales representative is assigned to the business unit. Technical Support: - Represents Medtronic during procedures and implants of products to provide troubleshooting and other technical assistance. - Receives technical inquiries by telephone. Research solutions to questions or problems (e.g. product selection issues, technical questions about Medtronic CRDN products when appropriate, etc.) Educational Support: - Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products and pacing through conducting and/or coordinating: - 1. One-on-one training sessions - 2. In-service education programs - 3. Seminars and/or outside symposiums - Assist DM, CSM and in-house training department in educating/training new Clinical Specialists and sales representatives. - Provide training and resources for hospital staff to enable them to conduct training for their personnel (“train the trainer”). Sales Support: - During/following cases: - Complete necessary documentation and phone calls (customer service). - Update sales representatives concerning cases. Immediately notifies representatives regarding issues or problems requiring follow-up. - Serves as effective Medtronic representative to physicians and support staff regarding Medtronic products, service, and support. - Maintain current knowledge regarding CRDN, Medtronic programs, products and services and competitive products. - Maintains open, effective communication with all district personnel, customers, and other Medtronic employees - Performs other related duties as assigned BASIC QUALIFICATIONS: - High School Diploma and 11 years clinical or sales experience in healthcare OR - Associate Degree and 9 years of clinical or sales experience in healthcare OR - Bachelor's Degree and 7 years of clinical or sales experience in healthcare DESIRED/PREFERRED QUALIFICATIONS (optional): - Relevant industry, healthcare, industry, marketing, or medical education experience considered where there is specific focus on awareness and education or medical project management.  - Expertise with Microsoft Outlook, Excel, Word and PowerPoint and system tracking.    - Strong project management skills and experience coordinating and executing marketing programs.  - Excellent interpersonal, written, and verbal communication skills.  - Excellent work ethic   - Thorough working knowledge of medical terminology, medical procedures, and the medical device industry.  - Excellent customer service skills and problem resolution skills.  - Ability to effectively build and maintain positive relationships with peers and colleagues across organizational levels.  PHYSICAL JOB REQUIREMENTS: - Continuous verbal and written communication. - Frequent 2-handed lifting of up to 40 lbs. from floor to chair/table and from one to another surface at approximately the same level - Sitting, standing and/or walking for up to eight plus hours per day - Environmental exposures include eye protection, infectious disease and radiation - Ability to wear 7-9 lbs of lead for extended periods of time while in the O.R. - Frequently required to use hands to finger, handle or feel objects, tools or controls - Ability to effectively use a mobile phone, PC, keyboard and mouse - Frequent bending/stooping, squatting and balance - Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer - Ability to travel extensively with ease - Must be able to drive approximately 80% of the time within assigned territory - Environmental exposure to infectious disease and radiation - Must have a valid driver's license and active vehicle insurance policy.  In addition, your driving record will be reviewed and will be considered as part of your application. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. 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):$120000 - $135000 In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. 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.

Clinical Research Coordinator Location: Boston, Massachusetts, USA Work Arrangement: Hybrid Job Type: Full-time (40 hours/week) Work Location: 50 Staniford Street, Boston, MA Salary: $21.00–$29.01 per hour Job Description: 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. Job 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.; and maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a six-month grace period from their hire date (up to one year if starting on a per diem basis) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions -Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met. -Recruiting patients for clinical trials and conducting 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 required 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) Clinical Research Coordinator (CRC): The Disparities Research Unit at Massachusetts General Hospital is seeking CRCs for a study focused on addressing health and healthcare inequities in socially vulnerable communities. CRCs focus on outreach to potential research participants for a large, multisite research study. They will obtain consent from participants in person at participating clinics or by phone. CRCs will maintain efficient tracking of research activities and will support the preparation of REDCap-based data collection systems. Based on participant preference, CRCs will facilitate administration of screening and follow up interviews, either by facilitating patient access to data collection links at designated time frames, or administering interviews verbally if patients request. CRCs will work with the research team to monitor and follow up with hard-to-reach cases; to troubleshoot challenges in meeting milestones; and to support assurance of data quality through fidelity and quality control checks. Clinical Research Coordinators should be personable, attentive to detail, proactive, enjoy interacting with patients and be comfortable with a fast pace of outreach and follow up. Bilingual in English and Spanish is a plus. Remote Type Hybrid Work Location 50 Staniford Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $21.00 - $29.01/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 (857)-282-7642. 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.

• Oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs • Work closely with cross-functional teams and clinical sites to drive study execution, site engagement, and operational excellence across clinical trials • Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites • Develop and maintain study-specific operational plans, training materials, and monitoring documentation • Review trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives