Clinical Research Assistant jobs at Henry Ford Village

Henry Ford Cancer offers a large number of clinical trials, which can offer new or developing treatments to patients before they are widely available. They also provide the opportunity to advance medical knowledge, prevent diseases and increase quality of life. Henry Ford researchers place a strong emphasis on clinical research. That means that most of our work investigates how research questions affect patient care directly. However, our oncology researchers also conduct lab or bench research (studies performed in the laboratory, sometimes at the cellular level), investigating new treatments or cell behaviors. GENERAL SUMMARY: Under minimal supervision the Research Study Coordinator II: * Coordinates research projects within guides of regulatory compliance and/or Code of Federal Regulation. * Provides technical support to Principal Investigators. Duties include but not limited to: * Interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study. * Direct contact with potential and enrolled study participants expected. * Provides other support as required. * May work on multiple studies at any given time. EXPERIENCE REQUIRED: * One (1) year of research project coordination experience. CERTIFICATIONS/LICENSURES REQUIRED: * SOCRA or ACRP and IATA certification preferred. Additional Information * Organization: Henry Ford Medical Group * Department: Cancer Clinical & Trans Resear * Shift: Day Job * Union Code: Not Applicable

**Company:** Teleflex **Expected Travel** : More than 50% **Requisition ID** :13046 Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** . **Interventional** - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, Ringer Perfusion Balloon Catheter, AC3 Optimus and AC3 Range Intra-Aortic Balloon Pumps and the OnControl Powered Bone Access System. Teleflex's product portfolio now also includes Passeo-18 Lux Peripheral Drug-Coated Balloon Catheter, Pantera Lux Drug-Coated Balloon Catheter, Orsiro Mission Drug-Eluting Stent, the PK Papyrus Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. **Position Summary** The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research. **Principal Responsibilities** - Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth. - Serve as primary point of contact for CRA escalations and issue resolution across assigned studies. - Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. - Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. - Train site personnel regarding the protocol and applicable regulatory requirements. - Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment. - Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review. - Facilitate corrective action assessment and maintain TMF in BIMO readiness. - Provide study status updates to Management team and develop sufficient resolution of identified action items. - Contribute to annual reports, data management, data analysis, and publication support. - Develop and assesses SOPs annually, as needed. - Maintain current knowledge of applicable US and international clinical regulations and guidance documents. - Participate in department systems and development initiatives including related trainings. - Support investigator meetings as needed. - Support Protocol Deviation and Adverse Event review and reporting. - Maintain credentialing requirements at hospitals and clinics as needed. - Complete projects and tasks consistent with corporate objectives. - Support the Clinical Operations team in general and with various improvement projects. - Perform other duties as assigned. **Education / Experience Requirements** - Bachelor of Science degree required. Preferably in natural sciences or related field, or related practical experience. - Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity. - Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc. - US IDE, IND, and OUS experience preferred. **Specialized Skills / Other Requirements** - Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action. - Excellent time management skills. - Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified. - Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment. - Ability to perform at high-level with limited supervision and effectively partner with team members when necessary. - Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria. - Ability to develop strong relationships with investigative sites. - Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. - Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. - Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. CULTURE: - Customer Experience - Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers. - Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. - Culture and Values - Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 50-75% (US and Internationally) The pay range for this position at commencement of employment is expected to be between $125,700- $188,600 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. \#LI-LM1 _At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************._ _Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._ _© 2025 Teleflex Incorporated. All rights reserved._

Expected Travel: More than 50% Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, Ringer Perfusion Balloon Catheter, AC3 Optimus and AC3 Range Intra-Aortic Balloon Pumps and the OnControl Powered Bone Access System. Teleflex's product portfolio now also includes Passeo-18 Lux Peripheral Drug-Coated Balloon Catheter, Pantera Lux Drug-Coated Balloon Catheter, Orsiro Mission Drug-Eluting Stent, the PK Papyrus Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. Position Summary The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research. Principal Responsibilities * Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth. * Serve as primary point of contact for CRA escalations and issue resolution across assigned studies. * Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. * Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. * Train site personnel regarding the protocol and applicable regulatory requirements. * Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment. * Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review. * Facilitate corrective action assessment and maintain TMF in BIMO readiness. * Provide study status updates to Management team and develop sufficient resolution of identified action items. * Contribute to annual reports, data management, data analysis, and publication support. * Develop and assesses SOPs annually, as needed. * Maintain current knowledge of applicable US and international clinical regulations and guidance documents. * Participate in department systems and development initiatives including related trainings. * Support investigator meetings as needed. * Support Protocol Deviation and Adverse Event review and reporting. * Maintain credentialing requirements at hospitals and clinics as needed. * Complete projects and tasks consistent with corporate objectives. * Support the Clinical Operations team in general and with various improvement projects. * Perform other duties as assigned. Education / Experience Requirements * Bachelor of Science degree required. Preferably in natural sciences or related field, or related practical experience. * Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity. * Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc. * US IDE, IND, and OUS experience preferred. Specialized Skills / Other Requirements * Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action. * Excellent time management skills. * Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified. * Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment. * Ability to perform at high-level with limited supervision and effectively partner with team members when necessary. * Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria. * Ability to develop strong relationships with investigative sites. * Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. * Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. * Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. CULTURE: * Customer Experience - Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers. * Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. * Culture and Values - Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 50-75% (US and Internationally) The pay range for this position at commencement of employment is expected to be between $125,700- $188,600 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-LM1 At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. 2025 Teleflex Incorporated. All rights reserved. Nearest Major Market: Minneapolis

Expected Travel: More than 50% As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner™ and Turnpike™ Catheters, Ringer™ Perfusion Balloon Catheter, AC3 Optimus™ and AC3 Range™ Intra-Aortic Balloon Pumps and the OnControl™ Powered Bone Access System. Teleflex's product portfolio now also includes Passeo™-18 Lux™ Peripheral Drug-Coated Balloon Catheter, Pantera™ Lux™ Drug-Coated Balloon Catheter, Orsiro™ Mission™ Drug-Eluting Stent, the PK Papyrus™ Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. Position Summary The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research. Principal Responsibilities • Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth. • Serve as primary point of contact for CRA escalations and issue resolution across assigned studies. • Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. • Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. • Train site personnel regarding the protocol and applicable regulatory requirements. • Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment. • Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review. • Facilitate corrective action assessment and maintain TMF in BIMO readiness. • Provide study status updates to Management team and develop sufficient resolution of identified action items. • Contribute to annual reports, data management, data analysis, and publication support. • Develop and assesses SOPs annually, as needed. • Maintain current knowledge of applicable US and international clinical regulations and guidance documents. • Participate in department systems and development initiatives including related trainings. • Support investigator meetings as needed. • Support Protocol Deviation and Adverse Event review and reporting. • Maintain credentialing requirements at hospitals and clinics as needed. • Complete projects and tasks consistent with corporate objectives. • Support the Clinical Operations team in general and with various improvement projects. • Perform other duties as assigned. Education / Experience Requirements • Bachelor of Science degree required. Preferably in natural sciences or related field, or related practical experience. • Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity. • Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc. • US IDE, IND, and OUS experience preferred. Specialized Skills / Other Requirements • Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action. • Excellent time management skills. • Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified. • Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment. • Ability to perform at high-level with limited supervision and effectively partner with team members when necessary. • Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria. • Ability to develop strong relationships with investigative sites. • Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. • Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. CULTURE: • Customer Experience - Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers. • Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. • Culture and Values - Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 50-75% (US and Internationally) The pay range for this position at commencement of employment is expected to be between $125,700- $188,600 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-LM1 At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2025 Teleflex Incorporated. All rights reserved.

**Company:** Teleflex **Expected Travel** : More than 50% **Requisition ID** :12724 Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** . **Interventional -** The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. **Position Summary** **TRAVEL REQUIRED: 70%** The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies and procedures) for assigned clinical studies in the field of vascular intervention or other therapeutic areas. **Principal Responsibilities** - Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicable. - Responsible for all monitoring activities for assigned clinical studies, including: o Scheduling and conducting monitoring activities onsite or remote within specified timelines and according to the risk-based monitoring plan and Teleflex procedures. o Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem-solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. o Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriate. o Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits, and proactively provides input on site performance. o Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. o Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparation. o Trains and mentors Teleflex personnel on monitoring procedures and practices. o Conducts site training and co-monitoring visits as requested by management. o Completes monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex procedures. o Assists with team, department, and study-related projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilities. **Education / Experience Requirements** - Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines. - Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO. **Specialized Skills / Other Requirements** - Demonstrated aptitude and knowledge in relevant therapeutic area. Vascular Interventional Cardiology is strongly preferred. - Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. - Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials. - Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). - Strong knowledge of medical terminology - Ability to work independently in a regional area with minimal supervision - Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. - Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. - Ability to interact constructively in communication of adherence to protocol and regulatory requirements. - Responsible for adequate and reasonable home office setup including dedicated desk space to accommodate work responsibilities and Teleflex-supplied equipment. CULTURE: - Customer Experience - Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers. - Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. - Culture and Values - Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. **TRAVEL REQUIRED: 70%** The pay range for this position at commencement of employment is expected to be between $105,000- $115,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. _At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************._ _Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._ _© 2025 Teleflex Incorporated. All rights reserved._

Expected Travel: More than 50% Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. Position Summary TRAVEL REQUIRED: 70% The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies and procedures) for assigned clinical studies in the field of vascular intervention or other therapeutic areas. Principal Responsibilities * Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicable. * Responsible for all monitoring activities for assigned clinical studies, including: o Scheduling and conducting monitoring activities onsite or remote within specified timelines and according to the risk-based monitoring plan and Teleflex procedures. o Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem-solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. o Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriate. o Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits, and proactively provides input on site performance. o Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. o Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparation. o Trains and mentors Teleflex personnel on monitoring procedures and practices. o Conducts site training and co-monitoring visits as requested by management. o Completes monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex procedures. o Assists with team, department, and study-related projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilities. Education / Experience Requirements * Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines. * Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO. Specialized Skills / Other Requirements * Demonstrated aptitude and knowledge in relevant therapeutic area. Vascular Interventional Cardiology is strongly preferred. * Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. * Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials. * Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). * Strong knowledge of medical terminology * Ability to work independently in a regional area with minimal supervision * Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. * Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. * Ability to interact constructively in communication of adherence to protocol and regulatory requirements. * Responsible for adequate and reasonable home office setup including dedicated desk space to accommodate work responsibilities and Teleflex-supplied equipment. CULTURE: * Customer Experience - Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers. * Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. * Culture and Values - Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 70% The pay range for this position at commencement of employment is expected to be between $105,000- $115,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. 2025 Teleflex Incorporated. All rights reserved. Nearest Major Market: Minneapolis

Expected Travel: More than 50% As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. Position Summary TRAVEL REQUIRED: 70% The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies and procedures) for assigned clinical studies in the field of vascular intervention or other therapeutic areas. Principal Responsibilities • Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicable. • Responsible for all monitoring activities for assigned clinical studies, including: o Scheduling and conducting monitoring activities onsite or remote within specified timelines and according to the risk-based monitoring plan and Teleflex procedures. o Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem-solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. o Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriate. o Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits, and proactively provides input on site performance. o Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. o Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparation. o Trains and mentors Teleflex personnel on monitoring procedures and practices. o Conducts site training and co-monitoring visits as requested by management. o Completes monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex procedures. o Assists with team, department, and study-related projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilities. Education / Experience Requirements • Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines. • Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO. Specialized Skills / Other Requirements • Demonstrated aptitude and knowledge in relevant therapeutic area. Vascular Interventional Cardiology is strongly preferred. • Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. • Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials. • Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). • Strong knowledge of medical terminology • Ability to work independently in a regional area with minimal supervision • Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. • Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. • Ability to interact constructively in communication of adherence to protocol and regulatory requirements. • Responsible for adequate and reasonable home office setup including dedicated desk space to accommodate work responsibilities and Teleflex-supplied equipment. CULTURE: • Customer Experience - Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers. • Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. • Culture and Values - Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data. TRAVEL REQUIRED: 70% The pay range for this position at commencement of employment is expected to be between $105,000- $115,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2025 Teleflex Incorporated. All rights reserved.

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

The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.

Job Description The START Center for Cancer Research (“START”) is the world's largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START's mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population - leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many - by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda - the most effective cancer drug in medical history. We are hiring a motivated Clinical Research Coordinator (CRC) will work under the guidance of senior research staff to support the daily activities of early phase oncology clinical trials. The CRC ensures the accurate and timely conduct of clinical research, adhering to protocols, regulatory requirements, and patient safety standards. This role involves direct patient interaction, data collection, and maintaining compliance with Good Clinical Practice (GCP). The Clinical Research Coordinator will be assigned multiple protocols at any time for which they will oversee the aspects of assigned protocols with planning and coordinating patient participation in the trial. Also, this role is responsible for implementation as well as completion of protocol specific requirements, providing accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements. Essential Responsibilities Communicate on a regular basis with Study Sponsor's, CRO's, staff, etc. regarding questions, concerns, as well as status of the protocol. Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study. Create/review forms created or revised for assigned trials to assure protocol compliance. Maintain files using standardized study document labeling and filing procedures. Implement initial protocol and amendments, training staff who will be involved in patient treatment and management. Maintain an up-to-date contact list. Assist with patient screening and determination of eligibility. Facilitate the informed consent process ensuring that consent is appropriately completed. Prepare and manage source documents according to standard operating procedures. Recognize deviations to the protocol and will work with leadership and staff to address corrective actions to prevent deviations. Assist data coordinator team with case report form completion and query resolution. Work with the Principal Investigator to complete and submit Serious Adverse Event reports. Perform protocol specific closeout related activities in conjunction with the data coordinator. Provide documentation for all deviations whether related to the protocol or a SOP. Ensure that all team members involved understand and adhere to assigned protocols. Required Education and Experience: High School Diploma or GED. 2 years of clinical research experience. Basic understanding of oncology clinical trials, particularly Phase 1 studies. Strong attention to detail and accuracy in data collection and documentation. Ability to manage multiple tasks and meet deadlines in a fast-paced environment. Excellent organizational and time-management skills. Strong communication skills, both written and verbal. Ability to interact professionally with patients, study staff, and external stakeholders. Working knowledge of GCP and regulatory requirements. Proficient in Microsoft Office Suite and clinical trial management software. Preferred Education and Experience: Experience working in an oncology setting. Physical & Travel Requirements: Approximately 80% of time is spent sitting. Very fast-paced and ever-changing healthcare environment. Demanding deadlines and time frames. Constant demand for updating knowledge. Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients. Best-in-Class Benefits and Perks We value our employees' time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including: Comprehensive health coverage: Medical, dental, and vision insurance provided Robust retirement planning: 401(k) plan available with employer matching Financial security: Life and disability insurance for added protection Flexible financial options: Health savings and flexible spending accounts offered Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Site: Mass General Brigham Incorporated 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 General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: - Careful attention to detail. - Good organizational skills. - Ability to follow directions. - Computer literacy. - Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: · Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable

Site: Mass General Brigham Incorporated 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 General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: * Careful attention to detail. * Good organizational skills. * Ability to follow directions. * Computer literacy. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: * Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

+ **Must have phlebotomy experience.** PURPOSE AND SCOPE: Supports Frenova Renal Research by providing administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity. PRINCIPAL DUTIES AND RESPONSIBILITIES: + Utilizes experience and knowledge to act as a resource and provide on-going leadership and support to Clinical Research Assistant I, answering questions and providing assistance as needed + Conducts on the job training for Clinical Research Assistant I as requested + Researches and identifies research related issues and discrepancies when evident and appropriately escalates to site manager, Director, and/or principal investigator for resolution as needed + Obtains and prepares regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms + Ensures documents and forms are compiled and submitted in a timely manner to Frenova Renal Research, CRO, study sponsor or IRB as applicable + Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff as necessary to ensure timely study start-up or the effective and efficient progression of the study + Assists with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of a study + Interfaces with potential study subjects for the purpose of promoting participation in research studies + Assists with screening subjects for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol and under the direction of the PI + Assists with and documents the obtaining of informed consent according to GCP + Responsible for the timely and accurate data entry of study specific data into case report forms. + Assists with addressing and resolving study sponsor questions, concerns, and queries in accordance with timelines established by the study sponsor + Processes and ships study specific lab specimens as directed by the PI + Performs study specific procedures at protocol directed intervals under the supervision of the PI + Provides general support for research projects as directed by the PI, Director, or other site personnel + Obtains and updates essential documents for specific studies, as necessary + Attends clinical research-related training as required + Assists with study close-out activities as directed by PI + Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner + Escalates issues to supervisor for resolution, as deemed necessary. + Assist with various projects as assigned by direct supervisor. + Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. + Other duties as assigned PHYSICAL DEMANDS AND WORKING CONDITIONS: + The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. + Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Day to day work includes desk and personal computer work and interaction with patients, field staff, physicians and study sponsors. + The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials. + Must be willing to travel to other research dialysis facilities as needed. Travel to Regional, Divisional and Corporate meetings may be required. 10% travel is required. EDUCATION: High School Diploma required; Associate's Degree or Certified Medical Assistant preferred. EXPERIENCE AND REQUIRED SKILLS: + 2-4 years of experience of related experience preferred. + Minimum 18 months experience in a medical setting and/or clinical research setting required + Willingness to obtain research specific training as needed. + Ability to meet deadlines for multiple concurrent projects. + Ability to understand and follow study specific protocol and direction. + Ability to understand a patient medical record. + Attention to detail required + Good computer skills including MS Excel. + Strong communication skills, verbal and written. + Strong organizational skills. + Ability to take direction. Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. **EOE, disability/veterans**

Must have phlebotomy experience. PURPOSE AND SCOPE: Supports Frenova Renal Research by providing administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity. PRINCIPAL DUTIES AND RESPONSIBILITIES: Utilizes experience and knowledge to act as a resource and provide on-going leadership and support to Clinical Research Assistant I, answering questions and providing assistance as needed Conducts on the job training for Clinical Research Assistant I as requested Researches and identifies research related issues and discrepancies when evident and appropriately escalates to site manager, Director, and/or principal investigator for resolution as needed Obtains and prepares regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms Ensures documents and forms are compiled and submitted in a timely manner to Frenova Renal Research, CRO, study sponsor or IRB as applicable Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff as necessary to ensure timely study start-up or the effective and efficient progression of the study Assists with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of a study Interfaces with potential study subjects for the purpose of promoting participation in research studies Assists with screening subjects for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol and under the direction of the PI Assists with and documents the obtaining of informed consent according to GCP Responsible for the timely and accurate data entry of study specific data into case report forms. Assists with addressing and resolving study sponsor questions, concerns, and queries in accordance with timelines established by the study sponsor Processes and ships study specific lab specimens as directed by the PI Performs study specific procedures at protocol directed intervals under the supervision of the PI Provides general support for research projects as directed by the PI, Director, or other site personnel Obtains and updates essential documents for specific studies, as necessary Attends clinical research-related training as required Assists with study close-out activities as directed by PI Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner Escalates issues to supervisor for resolution, as deemed necessary. Assist with various projects as assigned by direct supervisor. Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Other duties as assigned PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Day to day work includes desk and personal computer work and interaction with patients, field staff, physicians and study sponsors. The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials. Must be willing to travel to other research dialysis facilities as needed. Travel to Regional, Divisional and Corporate meetings may be required. 10% travel is required. EDUCATION: High School Diploma required; Associate's Degree or Certified Medical Assistant preferred. EXPERIENCE AND REQUIRED SKILLS: 2-4 years of experience of related experience preferred. Minimum 18 months experience in a medical setting and/or clinical research setting required Willingness to obtain research specific training as needed. Ability to meet deadlines for multiple concurrent projects. Ability to understand and follow study specific protocol and direction. Ability to understand a patient medical record. Attention to detail required Good computer skills including MS Excel. Strong communication skills, verbal and written. Strong organizational skills. Ability to take direction. Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. EOE, disability/veterans

At Lake Huron Medical Group, our dedicated team of professionals is committed to our core values of quality, compassion, and community. Affiliated with Lake Huron Medical Center, Lake Huron Medical Group is actively seeking new members to join its award-winning team! Responsibilities The Intake Representative interviews the patient or his/her representative to obtain identifying and verifying information, such as patient/s name, address, age, date of birth, social security number, occupation, insurance information and obtaining authorization. Must be able to operate a computer to input and retrieve data. Intake Representative is responsible for filing patient reports, retrieving patient records and must demonstrate effective telephone etiquette and greet patients and visitors in a polite and courteous manner. Ability to multi-tasked is needed to manage an efficient work-flow. Ability to utilize age specific techniques to communicate with the population served which could range from neonatal, pediatrics, adolescents, young adults, middle adult to geriatrics. Maintain proficiency in medical terminology. Special projects or other assignments may be given with expectations to be completed in a specified timeframe. Qualifications EDUCATION, EXPERIENCE, TRAINING 1. Previous experience as a medical office assistant within a medical clinic or similar experience preferred. 2. Knowledge of medical terminology preferred. Employment Status Full Time Shift Days Equal Employment Opportunity Company is an equal employment opportunity employer. Company prohibits discrimination against any applicant or employee based on race, color, sex, sexual orientation, gender identity, religion, national origin, age (subject to applicable law), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. The Company also prohibits harassment of applicants or employees based on any of these protected categories. Know Your Rights: ********************************************************************************************

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Outpatient Services at 1440 N Dayton Job Description Coordinates all behavioral research activities with moderate supervision. Adheres to the service values and principles as well as the principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: * Manages research projects, including study start-up, protocol coordination, monitoring, and close-out activities. * Maintains strict adherence to study protocols and regulatory standards throughout all phases of the study. * Manages study regulatory activities by preparing and maintaining all regulatory documents and regulatory agencies, including protocols, informed consent documents, recruitment materials, initial submissions, modifications, and renewals. * Maintains comprehensive study documentation such as regulatory binders and correspondence. * Coordinates the conduct of behavioral research projects with various departments, adheres to standard operating procedures (SOPs) to ensure adherence to research protocols and regulatory standards, and track deadlines for grants and deliverables. * Identifies and recruits eligible study subjects, manage the informed consent/assent process, coordinate the reimbursement of study participants, and serve as the primary liaison for participant inquiries. * Arranges and conducts research visits, including delivering behavioral interventions, such as administering surveys, facilitating interviews, and leading focus groups. * Abstracts and enters data from medical records onto protocol-specific case report forms and electronic systems, record data on source documents and CRFs, and conduct statistical analysis under PI supervision. * Conducts quality assurance activities by adhering to research protocols and applicable regulations (OHRP, FDA, GCP), performing QA/QC checks for database validity, and ensuring ongoing data monitoring to maintain high standards of research integrity. * Attends research meetings and actively participate in educational conferences to promote the ethical conduct of research and stay informed about best practices. * Participates in the preparation and presentation of research findings through abstract and poster development and assists in the writing and editing manuscripts. * Other job functions as assigned. Knowledge, Skills, and Abilities: * Bachelor's degree and one year research experience required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. * Proficient organizational skills with ability to manage multiple studies. Proficient verbal and written communications skills. * Proficient knowledge of FDA, HSR, and GCP Guidelines. * Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems. * Proficient entry level leadership skills. * Recognizes the need to prioritize tasks, problem solve, and work with others. * Assists to foster an inclusive environment where all team members feel valued and respect Education Bachelor's Degree (Required) Pay Range $49,920.00-$81,619.20 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: * Supplemental Life, AD&D and Disability * Critical Illness, Accident and Hospital Indemnity coverage * Tuition assistance * Student loan servicing and support * Adoption benefits * Backup Childcare and Eldercare * Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members * Discount on services at Lurie Children's facilities * Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

Job Details Schoolcraft Memorial Hospital - Manistique, MI Full Time None DayJob Posting Date(s) 10/16/2025Description The Clinical Assistant provides essential support to clinical staff and patients in a clinical setting. This role involves assisting with patient care, ensuring a smooth and efficient patient experience, and supporting nurses in various clinical tasks. DUTIES & RESPONSIBILITIES: Perform routine pre-examination procedures including taking vital signs. Collect basic medical history from patients and document any relevant health information. Assist physician / APP with examinations and procedures. Prepare and clean the patient area: set up equipment, clean and facilitate room set up after a procedure. Perform patient care measures as requested by provider. Assist in maintaining a clean and safe environment for patients and co-workers. Maintain and ensure confidentiality of Protected Health Information (PHI). Maintain a system for accurately recording and reporting patient conditions in the Electronic Medical Record. Follow providers' directive regarding communication to patients (i.e. test results, recommendations, etc.). Follow all SMH RHC policies and procedures. Attend required meetings/trainings and participate in committees as required. Demonstrate appropriateness in meeting objectives in age-specifics. Perform other duties as assigned. Qualifications High school graduate or equivalent. Previous nursing assistant or EMT preferred. Knowledge of basic medical terminology. Knowledge and relevant experience in a medical office setting. Ability to follow instructions, work as part of a team, and communicate effectively with patients and healthcare providers. Strong attention to detail and organizational skills. Must obtain Medical Assistant Certification within one year of hire. Training will be provided. BLS certification.

Job Details Schoolcraft Memorial Hospital - Manistique, MI Part Time High School None DayJob Posting Date(s) 10/09/2025Description The Clinical Assistant provides essential support to clinical staff and patients in a clinical setting. This role involves assisting with patient care, ensuring a smooth and efficient patient experience, and supporting nurses in various clinical tasks. DUTIES & RESPONSIBILITIES: Perform routine pre-examination procedures including taking vital signs. Collect basic medical history from patients and document any relevant health information. Assist physician / APP with examinations and procedures. Prepare and clean the patient area: set up equipment, clean and facilitate room set up after a procedure. Perform patient care measures as requested by provider. Assist in maintaining a clean and safe environment for patients and co-workers. Maintain and ensure confidentiality of Protected Health Information (PHI). Maintain a system for accurately recording and reporting patient conditions in the Electronic Medical Record. Follow providers' directive regarding communication to patients (i.e. test results, recommendations, etc.). Follow all SMH RHC policies and procedures. Attend required meetings/trainings and participate in committees as required. Demonstrate appropriateness in meeting objectives in age-specifics. Perform other duties as assigned. Qualifications High school graduate or equivalent. Previous nursing assistant or EMT preferred. Knowledge of basic medical terminology. Knowledge and relevant experience in a medical office setting. Ability to follow instructions, work as part of a team, and communicate effectively with patients and healthcare providers. Strong attention to detail and organizational skills. Must obtain Medical Assistant Certification within one year of hire. Training will be provided. BLS certification.