Clinical coordinator jobs in New Jersey - 752 jobs

Clinical Trial Associate - Consultant (No third parties or C2C) *This role is with a global pharmaceutical company located in NJ. Mandatory 3 days per week onsite* Key Responsibilities: Coordinate meetings, including scheduling, agenda preparation, and minute-taking. Gather data for feasibility assessments and site selection, and maintain site usability records. Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs. Assemble and update study manuals and maintain version control of study materials. Monitor site activation, enrollment, and study progress, and escalate any issues or deviations. Maintain investigator and site status updates, and support clinical trial registry postings. Perform regular reconciliations of the Trial Master File (TMF). Ensure timely receipt of required reports (e.g., 1572 changes, financial disclosures). Manage team SharePoint or shared drive sites and maintain site contact information. Assist in managing third-party vendors and tracking study close-out activities. Participate in SOP revisions and propose process improvements. Qualifications: Strong attention to detail and ability to manage study activities effectively. Good communication and interpersonal skills. Problem-solving abilities and proactive approach to tasks. Familiarity with trial management systems and MS Office applications. Basic understanding of clinical drug development and ICH/GCP guidelines. Experience: Bachelor's degree with 5+ of relevant experience

About the Company: Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Reporting to the Vice President, Clinical Development. The Clinical Trial Associate, Late Development (IIT, Registry) [GI] will play a key role in supporting the planning, execution, and management of late phase clinical trials by providing clinical, scientific, and administrative support. The role collaborates closely with the Clinical Trial Manager (CTM) and relevant teams in HQ to ensure effective trial conduct in accordance with applicable regulations and company policies. KEY ROLES AND RESPONSIBILITIES Support the preparation and maintenance of clinical trial documentation, including study protocols and Clinical Study Reports (CSRs), in compliance with regulatory and internal requirements. Provide operational support to Clinical Operations in collaboration with the CTM. Contribute evidence-based medical and scientific input to late-phase clinical trials under appropriate supervision. Support site selection activities and participate in site-boosting visits within the United States, as required. Prepare and maintain scientific literature summaries and assist in the development of clinical data presentations. Maintain regular communication with cross-functional stakeholders, including teams at Headquarters (South Korea). Support medical-related activities within the Clinical Development and Medical Affairs department in accordance with applicable laws, regulations, and company policies. This is a hybrid role. Can work on-site at our Jersey City, NJ office. WORK EXPERIENCE Minimum of three (3) years of experience in clinical research, clinical trials, or a related field Willingness and ability to travel up to approximately 25%, with or without reasonable accommodation QUALIFICATIONS Ability to learn and adhere to company policies, procedures, and compliance requirements Demonstrated ability to work proactively in a regulated environment Ability to communicate effectively in English, both verbally and in writing Demonstrated effective written and verbal communication skills Ability to collaborate effectively across multiple functional teams Ability to communicate in Korean at an intermediate level is preferred but not required EDUCATION Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related discipline, or an equivalent combination of education and experience. CORE COMPETENCIES Knowledge - medical terminology and regulatory requirements. Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Company's products. Collaboration - ability to communicate across functions and at all levels in the organization. Compliance - understands industry regulations to maintain compliance. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

The Patient Access Coordinator- Intake Specialist at Performance Ortho will support the Patient Access Team by managing the intake process, ensuring seamless scheduling, and delivering an extraordinary patient experience. Reporting directly to the Patient Access Manager, this role is critical to maintaining operational efficiency and meeting the needs of new and returning patients. Schedule: Onsite in our Bridgewater, NJ location Monday: 10:00am-3:00pm; 5:00-8:00pm (remote) Tuesday: 9:00am-6:00pm (1hr lunch) Wednesday: 10:00am-3:00pm; 5:00-8:00pm (remote) Thursday: 9:00am-6:00pm (1hr lunch) Friday: 9:00am-6:00pm (1hr lunch) Key Responsibilities Patient Intake: Address new patient inquiries and incoming calls professionally, providing timely and thorough assistance. Scheduling: Accurately manage appointments for new and returning patients, ensuring schedules align with patient and provider availability. Medical Record Coordination: Secure diagnostic tests, referrals, and chart notes from external facilities and ensure they are available for provider review. Documentation: Maintain complete and accurate records of patient interactions, including updates to charts and treatment plans. Paperwork Management: Provide patients with necessary forms, ensuring submission before their scheduled appointments. HIPAA Compliance: Uphold confidentiality and compliance standards in all patient interactions and data handling. Support Team Operations: Assist in maintaining productivity by contributing to team coverage, addressing time-sensitive tasks, and performing other duties as assigned by management. Qualifications Essential 3-5 years of experience in customer service, hospitality, or healthcare administration. Strong interpersonal and phone communication skills. Excellent problem-solving abilities and a commitment to providing exceptional patient care. Detail-oriented with the ability to manage multiple priorities in a fast-paced environment. Proficiency in administrative and office management tasks. Desired Experience in a medical or clinical office setting. Bachelor's degree in healthcare administration, business, or a related field. Familiarity with medical records management and scheduling software. What We Offer Competitive compensation and benefits package. Opportunities for professional development and growth. A supportive, team-driven environment that fosters innovation and excellence. Why This Role Matters This position ensures the Patient Access Team operates efficiently, meeting both patient care demands and operational goals. With a focus on professionalism, attention to detail, and patient satisfaction, the Patient Access Coordinator / Intake Specialist will contribute to the seamless delivery of high-quality care.

About us At Cooper University Health Care , our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development. Discover why Cooper University Health Care is the employer of choice in South Jersey. Short Description Assists the research manager, principal Investigator, and other members of the research team with preparation of IRB protocols, consent forms, data entry, and other tasks as needed. Completes and maintains all study documents as required. Assists with the identification and recruitment of study participants. Work as a team player with all involved in the studies. Experience Required Minimum 3-5 years of research experience required. Education Requirements Bachelors Degree preferred Special Requirements Basic understanding of Microsoft Excel, Outlook and Word.

Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management. We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you! Employment Type: Full Time Location: Freehold, NJ Compensation: $27.09 - $36.54 per hour Compensation packages based on your unique skills, experience, and qualifications As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. ESSENTIAL DUTIES AND RESPONSIBILITIES: Demonstrate understanding of the protocol elements and requirements. Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality. Screening, recruit, enroll prospective patients using EMR, EDC, CTMS Create and maintain enrollment logs for each trial from beginning to end Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial. Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial. Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance. Enter all the data to EDC, and EMR within 24 hours of data collection. Communicate and resolve all the data queries within 5-days Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator. Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times. Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements. Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues. Supports internal and external audits Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements. Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions. Conduct clinical trial weekly and monthly meetings within the division. Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings. Track and submit clinical trial patient reimbursement. Other duties as assigned. Requirements Minimum Job Qualifications: Minimum 1 year of experience with oncology interventional clinical trials. ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience. High School diploma with four years of oncology clinical trial experience. Computer literate with good interpersonal, writing, and verbal communication skills. Previous regulatory affairs experience is a plus. Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network. Prior experience working with centrifuge and handling biofluid specimens is preferred. Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure. Working Conditions: Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) Large percent of time performing computer based work is required The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. Salary Description $27.09 - $36.54

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Clinical Specialist, Cardiothoracic (CT) position provides strategic account management, expertise, and support with respect to Getinge Cardiac Assist products in an identified geographical area. The position provides customer training and education on responsible product portfolio including supporting product evaluations. The position supports and collaborates with the implementation team to ensure successful client outcomes. The position also indirectly sells and promotes Getinge Cardiac Surgery products within the defined geographic territory, by focusing on key accounts and expanding the usage of Cardiac Surgery products through clinical evaluations, presentations, and customer support. This territory will support the Northeast Region. Job Responsibilities and Essential Duties * Serve as a key business partner to clients in the field, by developing and maintaining strong customer relationships. * Develop and understand Business Plans for assigned geographic territory. * Develop relationships with hospital personnel (e.g., through casual conversation, meetings, participation in conferences) to make new contacts in other departments within the hospital. * Proactively understand customer needs and when complaints arise regarding products, develops creative and feasible solutions or working with other related personnel (e.g., clinical research, marketing) to develop optimal solutions. * Support the needs of the client, including but not limited to product demonstrations, in-services, case support, product complaints etc. In addition, identifying types of cases handled by specific customers by meeting with and asking in-depth questions of physicians and other hospital personnel to learn which Getinge products can best address their specific needs. * Observe actual procedures within varying departments of hospital accounts to gain insight into the specific nuances of each physician and each member of the clinical staff. Support in-services and staff training on assigned products. * Ongoing discussion and reviews with local reps to provide input on the needs, issues, and suggestions in the development of their business plans, to help the organization achieve its annual Cardiac Surgery sales goals. * Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals). * Establish and maintain a business climate that fosters positive and cooperative working relationships with customers, and all Getinge personnel, resolve problems that may develop to the mutual benefit of the customer and Getinge. * Comply with all health and safety codes and procedures as mandated by Getinge policies, customer requirements and regulatory agencies. * Support existing products utilized by customers and support new Cardiac Surgery installations as needed during regular visits with current customers and/or potential Cardiac Surgery customers to fulfill revenue and unit growth objectives assigned by company on a monthly/quarterly/annual basis. * Perform other related duties as required or assigned. Minimum Requirements * Bachelor's Degree or an equivalent combination of education and experience. * Minimum combined 5 year's applicable clinical experience in a Hospital environment and/or sales support including product education and training required. * Must have a valid driver's license. #LI-JW1 Required Knowledge, Skills and Abilities * Demonstrated record of success or achievement in clinical positions. * Solid understanding of specified functional area, and application of business concepts, procedures, and practices. * Capable of managing time and resources within the assigned territory in conjunction with near-term plans to ensure the territory's objectives are achieved. * Must perform this job in a quality system environment, ensuring compliance with governmental regulations and maintaining honesty, integrity, and excellent work ethics. * Be able to enhance teamwork within the region and maintain a collaborative relationship with all levels of the organization. * Good communication skills, organization and computer skills required. * Carry out operations within an established budget. * Must have sound knowledge of a variety of alternatives and their impact on the business and be able to exercise judgment in selecting innovative and practical methods to achieve problem resolution in the assigned territory. * Establish and cultivate an extensive network of support to facilitate completion of assignments. * Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel. * Basic to intermediate skills in Microsoft Excel, Word and Outlook and familiarity with CRM tools. * Use of computer and telephone equipment and other related office accessories/devices to complete assignments. * May work extended hours during peak business cycles. * The position requires travel of approximately 50% or more. * Must be able to lift up to 50 lbs. Sales salary range: Total Compensation= $160,000 - $165,200 (base + at plan target incentive) depending on experience and location About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: * Health, Dental, and Vision insurance benefits * 401k plan with company match * Paid Time Off * Wellness initiative & Health Assistance Resources * Life Insurance * Short and Long Term Disability Benefits * Health and Dependent Care Flexible Spending Accounts * Commuter Benefits * Parental and Caregiver Leave * Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Job DescriptionSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials. Responsibilities Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education). Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards. Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance. Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight. Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability. Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed. Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions. Stay current with regulatory updates and industry best practices to ensure training content remains relevant. Support development of study-specific training for CRAs and site personnel. Maintain documentation of all training activities for audit readiness. Qualifications Bachelor's degree in health sciences or related field. Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise. Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address. Excellent verbal and written communication skills; strong presentation and facilitation abilities. In-depth knowledge of ICH-GCP guidelines and clinical trial processes. Critical thinking for troubleshooting monitoring challenges Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO). Strong organizational and time management skills; ability to manage multiple priorities. Experience in developing training materials and delivering educational programs preferred. Ability to travel as needed (up to 25%). Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply. Powered by JazzHR 48DxHpXuU1

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials. Responsibilities * Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education). * Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards. * Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance. * Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight. * Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability. * Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed. * Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions. * Stay current with regulatory updates and industry best practices to ensure training content remains relevant. * Support development of study-specific training for CRAs and site personnel. * Maintain documentation of all training activities for audit readiness. Qualifications * Bachelor's degree in health sciences or related field. * Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise. * Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address. * Excellent verbal and written communication skills; strong presentation and facilitation abilities. * In-depth knowledge of ICH-GCP guidelines and clinical trial processes. * Critical thinking for troubleshooting monitoring challenges * Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO). * Strong organizational and time management skills; ability to manage multiple priorities. * Experience in developing training materials and delivering educational programs preferred. * Ability to travel as needed (up to 25%). Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM , which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; Beijing, China and Montevideo, Uruguay. There are 64 million patients struggling with Heart Failure worldwide. When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job; it is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy. This requires a team of the best medical device and therapy awareness representatives in the world to educate the cardiology community. The Clinical Research Associate will be assigned to support one or more Clinical Trial Manager(s) (CTM) responsible for the management of all aspects of the clinical study team (CST) activities for the assigned clinical trial(s). The CRA will be responsible for the coordination and management of all administrative, regulatory, and site management aspects of clinical trial(s) they are assigned to. How You Will Add Value: · Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, electronic or binder preparation for distribution. · Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review · Prepare CST meeting minutes. · Act as a resource for the clinical sites and research monitors for the trial. · Assist with training of site staff who are working on the study. · Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records. · Review various study-related tracking systems to determine and report status of clinical trial documents. Collect outstanding documents by contacting the clinical trial sites or working with the field monitors. · Send notifications to the clinical trial sites regarding their IRB renewal dates. · Maintain and audit all study related files in compliance with department standard operating procedures. · Assist with the follow-up and resolution of noted observations on audit and monitoring reports. · Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories. · Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies. · Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings. · Review and approve Site Qualification Reports for new clinical trial sites · Train users on the EDC/case report forms and other systems that may be used (i.e., electronic regulatory Binders). · Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment. What You are Bringing With You: · Bachelor's degree in life sciences or related field preferred. · 1-2 years clinical research experience with bachelor's degree or · 4 years clinical research experience with professional certification (CCRP, ACRP) · Experience with communicating with hospital administrators, research nurses and study coordinators. · Working knowledge of FDA regulations and Good Clinical Practices. · Experience with IBM eCRFs, ClinPlus CTMS, and Florence or other electronic data and/or regulatory solutions. · Medical device clinical trials experience Our Commitment to You Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions - and a better life for those living with diabetes - with the world's first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user's weight - the iLet does the rest. The iLet lets users "Go Bionic" with their diabetes management. * User must be carb aware. Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact. Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team! Beta Bionics is seeking a passionate and driven Clinical Diabetes Specialist to join our fast-growing startup. We're revolutionizing diabetes care with the iLet, the world's first closed-loop insulin delivery system with fully autonomous insulin dosing and no requirement to count carbs. In just our first 18 months on the market, we've experienced unprecedented growth-outpacing any other diabetes product launch! Our future looks even more exciting with the development of a patch pump and a bi-hormonal system utilizing insulin and glucagon. This is your chance to get in on the ground floor of an exciting, mission-driven start-up company. If you're a CDCES, interested in working in the industry or have already made a career in the industry, and passionate about healthcare innovation, we'd love to have you on our team. Join us and help shape the future of diabetes care! Summary/Objective: As the Clinical Diabetes Specialist, you are responsible for the promotion and clinical support of Beta Bionics products and services within your assigned geography. You are responsible for managing the training journey for people with diabetes. You will be the main point of contact for the educational needs of the iLet user, healthcare professionals and staff. In partnership with the Territory Business Manager and Inside Sales Specialists, you will develop a targeting and business strategy and develop and maintain strong relationships with our customers. This role requires that you work well in a collaborative environment with the ability to influence cross-functional team success. You must have strong planning and organizational skills with the ability to handle multiple priorities. You will operate with a passion to serve people living with diabetes and our communities. Essential Duties and Responsibilities [Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact] * Responsible for driving territory goals through strong clinical experience in diabetes * Manages, conducts, and supports the training journey for people with diabetes * Demonstrates strong teaching and training ability for providers and people with diabetes * Will use strong selling skills through a clinical medium * Works in conjunction with Territory Business Manager and Inside Sales Specialist to achieve territory goals * Maintains compliant communication/documentation with team through Salesforce.com * Assists with providing product demos to providers, people with diabetes and families * Demonstrates excellent communication and presentation skills * Responsible for training the trainer in provider offices * Demonstrates empathy with a passion to serve people with diabetes * Stands out as a Health Coach - sees the person with diabetes holistically * Demonstrates effective planning and organization skills with ability to handle multiple priorities * Ability to navigate and influence at all levels within an HCP and IDN environment Required Education and Experience * RN or RD * CDCES required * Acceptable licenses: APRN, NP, PA * Minimum requirement of 3 years diabetes experience Preferred Experience and Qualifications * 5+ years diabetes experience * Preferred industry experience Work Environment and Personal Protective Equipment * This is a field-based position. Candidate must reside in the geography specified in the job title Physical Demands * While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers * This position requires travel depending upon business needs Compensation and Benefits The annual base salary for this position is $90,000 - $110,000, plus an annual commission target, resulting in an annual earnings target of $128,000 - $148,000. Beta Bionics offers a competitive compensation package that includes equity and comprehensive benefit offerings. Beta Bionics offers healthcare benefits for employees and their families including medical, dental, and vision coverage, as well as flexible spending accounts (FSA) and a health savings account (HSA) that includes an annual company contribution. Our comprehensive benefits package also includes a 401k with a generous company match and no waiting period plus immediate vesting, an open PTO policy, and 10 paid holidays per year. Annual base salary will vary based on skills and experience, and may vary depending upon a candidate's location and relevant market data. Equal Employment Opportunity Statement It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.

Clinical Research Associate Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM , which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics. In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers. How You'll Add Value Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, and electronic or binder preparation for distribution. Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review Prepare CST meeting minutes. Act as a resource for the clinical sites and research monitors for the trial. Assist with training of site staff who are working on the study. Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records. Review various study-related tracking systems to determine and report the status of clinical trial documents. Collect outstanding documents by contacting the clinical trial sites or working with the field monitors. Send notifications to the clinical trial sites regarding their IRB renewal dates. Maintain and audit all study-related files in compliance with department standard operating procedures. Assist with the follow-up and resolution of noted observations on audit and monitoring reports. Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories. Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies. Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, and Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings. Review and approve Site Qualification Reports for new clinical trial sites Train users on the EDC/case report forms and other systems that may be used ( i.e., electronic regulatory Binders). Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment. What You're Bringing with You 1-2 years of clinical research experience with a bachelor's degree and/or 4 years of clinical research experience with professional certification (CCRP, ACRP) Experience with communicating with hospital administrators, research nurses, and study coordinators. Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements. Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions. Medical device and/or heart failure clinical trials experience preferred. Bachelor's degree in life sciences or related field preferred or equivalent work experience. Our commitment to you Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around the diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Annual Base Salary Range: $ 60,000 - $ 75,000 Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. Paid Vacation, floating holidays, and sick time. Paid Holidays 401k Match (up to 6%) Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description The Clinical Program Manager will work cross functionally to develop, track and maintain timelines, resource needs and Key Performance Indicators/Key Quality Indicators across clinical development, coordinate clinical program reviews, prepare tracking summary reports/dashboards for leadership and support the team in ensuring adherence to clinical program plan. Job Responsibilities: Enter and maintain resources estimates into PCH product portfolio/resource system Support the development of a standard clinical development timelines, internal KPIs/KQI and collaborate with Clinical development teams to align on these KPI/KQI Maintain and ensure accuracy and alignment of the different reporting tools pertaining to clinical development activities within the organization (timelines, resources, KPIs/KQIs) and develop a best practice process document to improve efficiency and decrease manual intervention. Provides monthly tracking project/KPI/resource reports Coordinate project reviews (sets agenda, prepares content, develop minutes, action plans and ensures follow up) Drive standardization of reporting for clinical development across the various medical franchise Manages PO for contractors Support teams in managing broad process improvement/innovation initiatives within clinical development Qualifications Requirements: Bachelor s Degree. A minimum of 4 years of experience in clinical development or related pharmaceuticals fields is preferred. Project Management Certification preferred, or minimally 3-5 years project experience including budget management experience. Strong planning, tracking, and follow-up skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management. Candidate must have strong knowledge and experience with MS project, planisware, or similar project management systems and excel. Candidate must possess strong communication skills, both oral and written, and the ability to collaborate and align with diverse, cross-functional teams. The candidate needs to have clinical experience, know how to create process maps and master excel. Project Management expertise and PM certification or direct PM training, most candidates to date are over-priced. please submit additional candidates -> Mid-Level Position 6 month position with possibility to be extended to 1 year, Strong planning, tracking, and follow-up skills - Proficient in Excel (including ability to understand programming) Please note: The manager is not looking for a study manager or a CRA/CTA. The candidate will not be working on the operational aspect of our clinical studies but will help project manage our clinical portfolio (across clinical programs/studies from pre-IND to NDA submission) Additional Information Neha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Responsibilities: - Build Virtual Reconstructions of Human anatomy and Pathology with Precision VR - Assist surgeons with Preoperative Surgical Planning and Surgical Navigation - Coordinate, schedule, and conduct VR events - Represent Company Procedures during surgeries - Provide hands-on and remote clinical support to customers - Basic VR video creation and editing Educate and train clinicians and hospital personnel We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements Experience: - Bachelor Degree in BioMed/ Biology/ related field - Knowledge of medical terminology, specifically related to neurosurgery - Excellent interpersonal and verbal communication skills - An ability to travel, dependent upon account distribution (quarterly basis) Anatomical medical image knowledge

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit s team is inspired to touch and help change lives through Summit s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit s Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Are you interested in new technology such as Virtual Reality? Have you ever worked in a clinical setting and/or have a desire to help people? Does a major contribution to the advancement of medicine appeal to you? Our mission is to change medicine. We are growing rapidly and are now hiring for an exciting position called XR Clinical Specialist. The individuals we hire for the XR Clinical Specialist role become experts in use of our advanced visualization platform, Precision XR™. They are primarily responsible for technical, educational, and sales support, with both existing and potential customers, to ensure superior outcomes. In addition, the XR Clinical Specialist will build and maintain solid customer relationships, at all levels within their account, and promote the expanded utilization of Company systems. Job Description: Build Virtual Reconstructions of Human anatomy and Pathology with Precision XR™ Assist surgeons with Preoperative Surgical Planning and Intraoperative Surgical Navigation Coordinate, schedule, and conduct XR events Represents Company Procedures during surgeries and patient engagement to provide technical assistance. Provides hands on and remote clinical support to customers. Fulfills Software and Service Contract obligations Basic XR video creation and editing. Educates and trains clinicians and hospital personnel. Assist clinicians in the utilization of Precision XR™ during patient consultations. Provide Precision XR™ expertise during multidisciplinary education sessions (i.e.: Tumor Board) Provides a clinical resource for surgeons, clinicians, and hospital staff. Assists commercial leadership in educating/training new sales representatives and Clinical Specialists. Represents company standards during surgical evaluations and demonstrations. Introduces more complex products and applications to physicians and hospital staff. Works as a team member with the Commercial Sales Team to prioritize customer technical support and service expectation goals. Provides potential leads for new products and customers to the Commercial Team Requirements/Qualifications: Degree, credentials, or experience in a relevant area Excellent interpersonal and verbal communication skills Mechanical/technical ability and manual dexterity Knowledge of medical terminology, specifically related to neurosurgery. Knowledge of 3D stereotactic equipment is preferred. An ability to travel 20-60%, dependent upon account distribution. A medical device background is preferred. Willingness to work a flexible schedule ARRT Certification a plus Open to relocation

Field Clinical Specialist - (Morristown) Remote/Field role InspireMD is a dynamic growing company focused on developing and commercializing innovative Class III PMA and Class II medical devices. We are seeking a Field Clinical Specialist (FCS) to join our team. In this role, you will be responsible for providing world class training, case planning and support to customers using or interested in using InspireMD products. Reporting to a Regional Sales Director, the FCS will work with Territory Managers (TMs), fellow FCSs and other functions (Training/Commercial Development, Clinical Affairs, etc.) to support customers in both the clinical and commercial settings to support the overall success of InspireMD's launches of CGuard Prime and SwitchGuard. Key Responsibilities: A Field Clinical Specialist is responsible for providing world class training, case planning and support to customers using or interested in using InspireMD products. Support and influence all customer types- (Interventional, Vascular, and Neuro Interventional, supporting both CAS and TCAR procedures to optimize patient outcomes, to include the creation of case plans. Collaborate with RSD and TMs to target and maximize CAS, TCAR and neuro (to include tandem lesion) opportunities, as product approvals and launches allow. Collaborate with commercial development to enhance professional education (physician/customer) programs as requested. Collaborate with Clinical Affairs to provide outstanding case support for clinical trials, as requested. Leverage and build customer relationships to support commercialization/product launch, professional education, and field training efforts. Inspection Support: Support FDA inspections and audits, ensuring that all regulatory and complaint handling documentation is in order and facilitating smooth interactions with regulatory authorities. Qualifications: Minimum of five (5) years of experience in the medical device industry or clinical/patient care, including prior experience with Interventional Cardiology/Radiology/Neurology and/or Vascular Surgery. Prior experience with innovative medical products; Endovascular experience. Educational degree or certification in a business, life sciences or a healthcare discipline.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This field-based position is based in either New York or New Jersey. Purpose and Scope: A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: * Site Selection * Pre-trial assessment * Site level Study Participant recruitment/retention plans * Site Activation/Initiation * On-site and remote monitoring * Overall site relationship management in collaboration with other sponsor roles that interact with the site * Close-out activities Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Responsibilities & Accountabilities: * Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. * Develops meaningful site relationships through consistent collaborative communication and engagement. * May participate in site feasibility and/or pre-trial site assessment visits. * Attends/participates in investigator meetings as needed. * May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. * Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. * Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. * Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. * Ensure ongoing adequacy of site (facilities, staff) for trial conduct. * Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA * Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. * Ensures site non-IMP study supplies are adequate for trial conduct. * Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. * Oversees the appropriate destruction of clinical supplies. * Ensures site staff complete data entry and resolve queries within expected timelines. * Ensures validity and completeness of data collected at trial sites. * Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. * Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. * Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. * Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. * Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. * Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. * Prepares trial sites for close out, conduct final close out visit. * Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. * May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. * May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven

About Sequel Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel's approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel's flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management. Job Overview As a Clinical Diabetes Specialist (CDS) you will partner with a Territory Business Leader (TBL) to successfully launch a new innovative insulin pump and future Sequel products. Your primary responsibility is to deliver unparalleled clinical education and product training for people with diabetes and healthcare providers to drive product adoption and support persistent use. In partnership with the TBL, you will formulate territory strategies and initiatives to meet/exceed territory goals. As a Senior Clinical Diabetes Specialist, you will additionally take on a leadership role within the team by mentoring junior staff, assisting with field sales training, and participating on internal advisory boards. Territory includes Northern New Jersey (Paramus, Hackensack, Newark, Patterson), Rockland County, NY and Lower Westchester (Yonkers, New Rochelle).Job Responsibilities and Essential Duties Develop effective territory planning and strategies with TBL to meet/exceed territory goals. Execute clinical selling strategies within assigned accounts. Assess referrals for product use in people with diabetes to confirm criteria are met for product utilization. Facilitate product education and training for users of Sequel products. Drive healthcare provider adoption and confidence in Sequel products by promoting the clinical benefits of automated insulin delivery with Sequel products and conducting impactful product demonstrations. Certify healthcare providers to conduct product training for people with diabetes. Facilitate virtual product training and other educational webinars. Communicate user feedback cross-functionally to solve problems and improve product development. Collaborate with customer care and sales support to optimize the user experience. Consistently exhibit a high level of proficiency and expertise in discussing and demonstrating Sequel products, as well as expertise in diabetes and therapeutic options for diabetes care. Participate in conventions, educational forums, and meetings to increase product awareness. Manage all leads and opportunities in customer relations database daily and submit product training documentation as required. Maintain a high profile with state and local patient advocacy groups and professional diabetes organizations, such as local chapters of ADA (American Diabetes Association), ADCES (Association of Diabetes Care and Education Specialists), and Breakthrough T1D (formerly known as Juvenile Diabetes Research Foundation). The Senior Clinical Diabetes Specialist will have the following additional responsibilities: Assist with field sales and clinical training. Participate in advisory boards with cross-functional departments. Mentor junior staff. As needed, lead weekly team calls, regional and/or area calls and/or meetings. Minimum Requirements A valid professional license in one or more of the following fields: RN, RD, PA, NP, Pharmacist. Certified Diabetes Care and Education Specialist (CDCES) is preferred. 2+ years of experience coordinating and conducting diabetes education with strong experience in the technical use of diabetes technology preferred. For the Senior CDS role: Certified Diabetes Care and Education Specialist (CDCES) certification required. 4+ years of clinical diabetes education experience. Experience coordinating and conducting diabetes device education in the medical device industry preferred. Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. At Sequel, we believe that when you thrive, we thrive. That's why our benefits package is designed to support you from day one. You'll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting. We're committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans. You'll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA). Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care. In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind. We know the importance of taking time to rest and recharge. That's why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most. Our team enjoys a culture built on hard work, fun, and genuine support. At Sequel, you're not just starting a job, you're building a rewarding career and a brighter future. Join us, and let's thrive together! Environmental/Safety/Physical Work Conditions Ensures environmental consciousness and safe practices are exhibited in decisions Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles Physical requirements such as lifting specific weights Some travelling is expected