Edwards Lifesciences logo
Edwards Lifesciences

Global leader in the medical device industry with a patient-focused culture of innovation

Senior Specialist, Clinical Research Monitoring

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 10,001+Since 1958H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$108K - $153K / year

Seniority

Senior

No structured requirement data.

Job Description

Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences

Role Description Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: - Field monitoring of studies and data collection for clinical trials. - Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determining if clinical trial/study subject documentation is within parameters of study hypothesis. - Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Training and proctoring new employees on trial and study related activities. - Acting as a mentor to new or junior level employees. - Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff. - Supporting study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements. - Contributing to the development of clinical protocols, informed consent forms, and case report forms. - Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. - Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external. - Auditing to ensure the site has the appropriate regulatory documentation to conduct the trial/study. - Ensuring source documentation is properly recorded. - Editing/amending informed consent documents. Qualifications - Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria. - Ability to travel up to 75% domestically. Requirements - Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) (Preferred). - Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills (Preferred). - Demonstrated problem-solving and critical thinking skills (Preferred). - Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery (Preferred). - Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise (Preferred). - Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting (Preferred). - Technical writing skills (protocols, CRF development, study tools) (Preferred). - Ability to communicate and relate well with key opinion leaders and clinical personnel (Preferred). - Experience in training new hires (Preferred). Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. Company Description Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement: Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies. • Responsibilities may include but are not limited to: - Screening of patients for study enrollment; - Patient consents; - Patient follow-up visits; - Documenting in source clinic charts; - Entering data in EDC and answering queries; - Obtaining vital signs and ECGs; - May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; - Requesting and tracking medical record requests; - Updating and maintaining logs, chart filings; - Maintaining & ordering study specific supplies; - Scheduling subjects for study visits and conducts appointment reminders; - Building/updating source as needed; - Conducting monitoring visits and resolves issues as needed in a timely manner; - Ensuring study related reports and patient results are reviewed by investigator in a timely manner; - Filing SAE/Deviation reports to Sponsor and IRB as needed; - Documenting and reporting adverse events; - Reporting non-compliance to appropriate staff in a timely manner; - Maintaining positive and effective communication with clients and team members; - Always practicing ALCOAC principles with all documentation; - Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; - Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed; - Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed; - Assist with training of new research assistants and coordinators; - Assist with scheduling and planning for visit capacity for assigned studies; - May set up, train and maintain all technology needed for studies; - May assist with study recruitment, patient enrollment, and tracking as needed; - May handle more complex study assignments and volumes; - May participate in community outreach/education events; - Maintaining confidentiality of patients, customers and company information, and; - Performing all other duties as requested or assigned.

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Rho, Inc. logo

Clinical Team Lead

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Role Description We are hiring a Clinical Team Lead! This is a permanent role to work remotely, with the expectation of occasional travel for site visits and client meetings. The Clinical Team Lead (CTL) is responsible for managing and maintaining ownership of the clinical operations aspects of assigned projects. This position is responsible for providing direction and training to CRAs assigned to the project. In addition, the CTL is responsible for the oversight of all operational aspects related to the planning and oversight of CRA and site performance. The CTL is responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations. - Manages the end-to-end clinical execution of projects up to moderate complexity and scope and/or supports a senior-level CTL on more complex or larger scope projects, ensuring adherence to protocols, timelines, and regulatory requirements. - Oversees recruitment, study metrics monitoring, and documentation activities. With guidance, identifies issues and contributes to implementing solutions. - Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations. - Collaborates with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables. - Develops and manages clinical operation timelines, metrics, resourcing, budget and activities of projects up to moderate complexity and scope. May also support senior CTLs on more complex or larger scope projects. - Identifies potential risks and escalates to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies. - Manages tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identifies potential budget variances and escalates to appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is maintained. - May assist with RFP strategic planning, budget development, and capabilities/response narratives. - Performs monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Works with CRA Line Management to proactively confirm resourcing needs. - Serves as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity. - Leads internal and external meetings. - Manages routine Client communications and helps manage client expectations. - Communicates and works effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise. - Leads CRAs and IHCRAs, including project training and onboarding. - Creates and conducts training sessions including investigator meetings, conferences, and team training. - Provides constructive performance feedback on CRAs/IHCRAs to line managers and project leads. - May participate in Bid Defense Meetings to present clinical operation and monitoring strategy. - Participates in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities. - Manages protocol deviation review and reconciliation throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and Client for review and approval on projects of up to moderate complexity. - Supports the identification and continuous assessment of clinical risks throughout the study and contributes to the development and implementation of risk mitigations on projects of up to moderate complexity. - Provides skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms). - Oversees and performs on-site Quality Compliance Visits to review data across CRAs using a targeted, adaptive and/or risk-based approach focused on critical and safety related data points. Identifies trends and potential quality issues, escalating as appropriate. Collaborates with CRAs and study teams to implement corrective and preventive actions. Qualifications - Bachelor's Degree, preferably in a life science, nursing, pharmacy or related field. - 5 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry. - At least 2 years of experience working as a clinical team lead preferred. - At least 2 years of on-site monitoring experience. - Proven leadership capabilities with experience in leading teams within a CRO or pharmaceutical setting. - Strong knowledge of GCP and regulatory requirements, as well as familiarity with clinical trial processes and documentation. - Excellent interpersonal and communication skills, able to build relationships with clients and teams. - Demonstrated ability to manage multiple priorities and deliver on deadlines in a fast-paced environment. - A proactive, solutions-oriented mindset with the ability to drive decisions and lead initiatives. - Experience using clinical trial management software and EDC systems. Benefits - Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

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Title: MDS Solutions - Clinical Reimbursement Specialist Location: Fargo, North Dakota, United States Department: Administrative/Clerical Remote ID : 2026-4755 Category :Administrative/Clerical Job Description: Overview MDS Solutions, a division of Key Rehabilitation, is looking for fun, energetic, and self-driven team members to join our remote MDS division as a Clinical Reimbursement Specialist. Clinical Reimbursement Specialist (CRS) The Clinical Reimbursement Specialist (CRS) plays a critical role in supporting clients through specialized project work, including conducting RAI assessments, developing comprehensive care plans, and delivering targeted education and training to MDS Coordinators on the Resident Assessment Instrument (RAI) process. This work is performed in strict alignment with applicable laws, regulations, and company standards. The CRS also reviews reimbursement systems for PDPM and Case Mix to ensure accurate and optimized reimbursement. Additionally, the CRS provides support with interim long-term and short-term contract coordination, ensuring the smooth completion of these efforts About Us: At Key Rehab, we’re shaking up rehab services with a fresh, standout approach. We offer a wide range of services, stick to top-notch systems, and work in strategic locations to get the best results for our patients and support our clients' goals. We’re all about clear communication, using our deep experience to deliver therapy that's both effective and affordable. Our reputation is built on great patient care, happy clients and staff, and solid management. We are proud to exceed expectations for patients, families, healthcare providers, and businesses. We prioritize both exceptional patient care and the well-being of our employees. We are committed to delivering compassionate, results-driven therapy while offering the flexibility and comprehensive benefits needed to thrive in today’s healthcare environment. Our team is large enough to offer competitive pay and benefits but small enough to ensure personalized attention and support for your career aspirations. Whether you’re looking for a role that accommodates family commitments, travel plans, home projects, or future savings, we provide tailored solutions to fit your lifestyle. Join us and experience a workplace that values your individual needs and career goals. Come experience a rewarding career where you’re valued and supported every step of the way. We offer a creative, engaging, and flexible work environment, alongside a comprehensive benefits package designed to support your success and well-being: - Competitive salaries with bonus opportunities - Ample opportunities for promotion, transfer, and advancement - Work that is meaningful, fulfilling, and provides high job satisfaction - Reasonable working hours promoting work-life balance - Continuing education (CE) opportunities for ongoing professional development - Generous paid time off - Comprehensive health, dental, and life insurance packages - 401K with discretionary matching - Mileage and licensure reimbursements - Flexible Spending Account (FSA) and Health Savings Account (HSA) options Responsibilities - Serve as a trusted advisor to healthcare agencies and facilities, offering expert guidance and insights to optimize their operations. - Assist clients in assessing, planning, developing, and implementing systems and processes related to reimbursement, tailored to the specific needs and contracts established with each client. - Provide consulting services and technical expertise, including interim MDS management, ensuring providers receive the support they need to achieve optimal outcomes. - Stay up-to-date on professional standards of clinical care, federal and state regulations, QM measures, and the RAI process to ensure the delivery of accurate, compliant, and effective solutions. - Deliver high-quality, professional services that encompass reimbursement optimization, staff education, in-depth research, system analysis, creative problem-solving, and the presentation of actionable recommendations to clients. - Identify and address training needs, developing and conducting training sessions or in-service programs as requested by clients to enhance staff competency and performance. - Operate within the defined scope of work, maintaining strict adherence to client agreements and expectations. - Uphold client confidentiality and ensure full compliance with HIPAA regulations, safeguarding sensitive information throughout the engagement. 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Title: MDS Solutions - Clinical Reimbursement Specialist Location: Cedar Rapids, Iowa, United States Department: Administrative/Clerical ID: 2026-4759 Job Description: MDS Solutions, a division of Key Rehabilitation, is looking for fun, energetic, and self-driven team members to join our remote MDS division as a Clinical Reimbursement Specialist. Clinical Reimbursement Specialist (CRS) The Clinical Reimbursement Specialist (CRS) plays a critical role in supporting clients through specialized project work, including conducting RAI assessments, developing comprehensive care plans, and delivering targeted education and training to MDS Coordinators on the Resident Assessment Instrument (RAI) process. This work is performed in strict alignment with applicable laws, regulations, and company standards. The CRS also reviews reimbursement systems for PDPM and Case Mix to ensure accurate and optimized reimbursement. Additionally, the CRS provides support with interim long-term and short-term contract coordination, ensuring the smooth completion of these efforts About Us: At Key Rehab, we’re shaking up rehab services with a fresh, standout approach. We offer a wide range of services, stick to top-notch systems, and work in strategic locations to get the best results for our patients and support our clients' goals. We’re all about clear communication, using our deep experience to deliver therapy that's both effective and affordable. Our reputation is built on great patient care, happy clients and staff, and solid management. We are proud to exceed expectations for patients, families, healthcare providers, and businesses. We prioritize both exceptional patient care and the well-being of our employees. We are committed to delivering compassionate, results-driven therapy while offering the flexibility and comprehensive benefits needed to thrive in today’s healthcare environment. Our team is large enough to offer competitive pay and benefits but small enough to ensure personalized attention and support for your career aspirations. Whether you’re looking for a role that accommodates family commitments, travel plans, home projects, or future savings, we provide tailored solutions to fit your lifestyle. Join us and experience a workplace that values your individual needs and career goals. Come experience a rewarding career where you’re valued and supported every step of the way. We offer a creative, engaging, and flexible work environment, alongside a comprehensive benefits package designed to support your success and well-being: - Competitive salaries with bonus opportunities - Ample opportunities for promotion, transfer, and advancement - Work that is meaningful, fulfilling, and provides high job satisfaction - Reasonable working hours promoting work-life balance - Continuing education (CE) opportunities for ongoing professional development - Generous paid time off - Comprehensive health, dental, and life insurance packages - 401K with discretionary matching - Mileage and licensure reimbursements - Flexible Spending Account (FSA) and Health Savings Account (HSA) options Responsibilities - Serve as a trusted advisor to healthcare agencies and facilities, offering expert guidance and insights to optimize their operations. - Assist clients in assessing, planning, developing, and implementing systems and processes related to reimbursement, tailored to the specific needs and contracts established with each client. - Provide consulting services and technical expertise, including interim MDS management, ensuring providers receive the support they need to achieve optimal outcomes. - Stay up-to-date on professional standards of clinical care, federal and state regulations, QM measures, and the RAI process to ensure the delivery of accurate, compliant, and effective solutions. - Deliver high-quality, professional services that encompass reimbursement optimization, staff education, in-depth research, system analysis, creative problem-solving, and the presentation of actionable recommendations to clients. - Identify and address training needs, developing and conducting training sessions or in-service programs as requested by clients to enhance staff competency and performance. - Operate within the defined scope of work, maintaining strict adherence to client agreements and expectations. - Uphold client confidentiality and ensure full compliance with HIPAA regulations, safeguarding sensitive information throughout the engagement. 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Iowa