Senior Clinical Research Associate
2 weeks ago
BrioHealth Solutions is on the lookout for skilled Clinical Research Associates (CRAs) to enhance our team and support the development of our cutting-edge LVAS device. As a Senior CRA, you will be instrumental in overseeing clinical trial data and ensuring the effective execution of our research initiatives.
Key Responsibilities:- Establish and manage study documentation, overseeing eTMF and supporting CTMS operations.
- Coordinate clinical study sites, ensuring the provision of trial materials and delivering training to site personnel.
- Oversee study management tasks including eTMF documentation, preparation of trial reports, and monitoring of adverse events.
- Facilitate investigator meetings, conduct pre-study assessments, and nurture relationships with clinical sites.
- Handle submissions to IRBs/ECs and Regulatory Authorities, manage device accountability, and oversee trial supplies.
- Independently generate reports, conduct User Acceptance Testing, and revise SOPs as necessary.
- Bachelor's degree or higher in a relevant scientific discipline.
- Demonstrated expertise in clinical trial operations and relevant regulatory frameworks.
- Familiarity with GCP, medical terminology, and statistical methodologies.
- A minimum of 3 years of experience in clinical trials for medical devices.
- Readiness to travel frequently as required.
For Senior CRA applicants:
- At least 8 years of clinical research experience, particularly in medical device trials.
- Comprehensive knowledge of FDA regulations, protocol formulation, and experience leading CRA teams.
About BrioHealth Solutions Inc:
BrioHealth Solutions is comprised of dedicated Med-Tech professionals committed to developing patient-focused solutions. Our BrioVAD LVAS technology is designed to offer chronic mechanical circulatory support to patients with heart failure globally. Join us in our endeavor to enhance patient outcomes and broaden access to essential therapies.
-
Lead Clinical Research Associate
2 weeks ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timePosition Overview: Senior Clinical Research Associate at BrioHealth SolutionsBrioHealth Solutions is in search of committed Clinical Research Associates (CRAs) to enhance our team and support the development of our cutting-edge LVAS device. As a Senior CRA, you will be instrumental in overseeing clinical trial data and ensuring the efficacy of our research...
-
Senior Quantitative Researcher
1 week ago
Boston, Massachusetts, United States FactSet Research Systems Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director to join our Fixed Income Research and Development team at FactSet Research Systems Inc. This is a unique opportunity to lead a team of researchers and contribute to the development of advanced quantitative models and concepts for fixed income analytics.Key ResponsibilitiesLead a...
-
Senior Biostatistician
2 weeks ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY:OVERVIEW STATEMENT:This role encompasses the statistical evaluation and programming for extensive international clinical studies. Ideal candidates will possess advanced formal education in statistics or biostatistics, with a focus on the design and analysis of both observational and experimental research, alongside robust statistical...
-
Clinical Research Associate
2 weeks ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT: The Clinical Research Coordinator is essential in advancing multiple research initiatives focused on the health-related challenges faced by refugees and asylum-seekers, particularly those experiencing cognitive difficulties, traumatic brain injuries, and associated mental health conditions. This role also addresses...
-
Clinical Research Associate
1 week ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT: The Clinical Research Coordinator plays a crucial role in various research initiatives focused on the health-related challenges faced by refugees and asylum-seekers, particularly those experiencing cognitive impairments, traumatic brain injuries, and associated psychiatric conditions. This position also addresses the...
-
Clinical Research Specialist III
1 week ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timePosition Overview: Senior Clinical Research Associate at BrioHealth SolutionsBrioHealth Solutions is in search of experienced Clinical Research Associates (CRAs) to enhance our team and support the advancement of our cutting-edge LVAS device. As a Senior CRA, you will be instrumental in overseeing clinical trial data management and ensuring the effective...
-
Senior Research Associate
5 days ago
Boston, Massachusetts, United States InsideHigherEd Full timeAbout the PositionWe are seeking a highly skilled and experienced Senior Research Associate to join our team at InsideHigherEd. The successful candidate will be responsible for leading research initiatives and projects, developing and implementing research strategies, and collaborating with colleagues to advance our understanding of long-term services and...
-
Boston, Massachusetts, United States Brigham and Womens Hospital Full timeJob Description – Clinical Research Senior Project Manager Psychiatry () The Division of Addiction Psychiatry is looking for a dynamic and detail–oriented Senior Clinical Research Project Manager who possesses a growth mindset to help support the development of our lab. Under the general direction of the Division Senior Administrator and the Division...
-
Clinical Research Coordinator Senior
5 days ago
Boston, Massachusetts, United States Beth Israel Deaconess Medical Center Full timeJob SummaryWe are seeking a highly skilled and experienced Clinical Research Coordinator Senior to join our team at Beth Israel Deaconess Medical Center. The successful candidate will be responsible for managing and overseeing the recruiting, screening, and enrolling of patients for participation in multiple clinical trials, ensuring compliance with federal,...
-
Senior Clinical Research Associate/CRA II
2 days ago
Boston, Massachusetts, United States KCR Full timeJob SummaryWe are seeking a highly skilled and experienced Clinical Research Associate to join our team at KCR. As a Clinical Research Associate, you will be responsible for performing site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable requirements.Key ResponsibilitiesPerform site visits and monitoring...
-
Research Associate/Senior Research Associate
3 days ago
Boston, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob SummaryWe are seeking a highly skilled Research Associate/Senior Research Associate to join our team at Beacon Hill Life Sciences - Boston. As a key member of our analytical chemistry group, you will be responsible for operating and maintaining complex instruments, developing analytical methods, and interpreting research data.Key...
-
Clinical Trial Associate
1 month ago
Boston, Massachusetts, United States Pharmaceutical Research Associates, Inc Full timeOverview As a Clinical Trial Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day–to–day operational activities of assigned trials...
-
Clinical Research Coordinator I
1 week ago
Boston, Massachusetts, United States Brigham and Women's Hospital Full timeJob Title: Clinical Research Coordinator I - Psychiatry PositionCompany: Brigham and Women's HospitalThe Department of Psychiatry at Brigham and Women's Hospital is seeking a highly skilled Clinical Research Coordinator I to join our team. The successful candidate will have the opportunity to work on a variety of research studies focused on major psychiatric...
-
Clinical Trials Research Associate
1 week ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT: The Mass General Brigham team is at the forefront of advancing diagnostic methodologies for infectious diseases. We are currently seeking a dedicated and enthusiastic Clinical Research Coordinator to contribute significantly to our innovative projects. This role will involve engaging in various research initiatives...
-
Senior Research Analyst
3 days ago
Boston, Massachusetts, United States National Institute for Children s Health Quality Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Research Analyst to join our team at the National Institute for Children's Health Quality. As a key member of our Applied Research and Evaluation team, you will be responsible for leading and managing clinical research-focused maternal child health projects.Key ResponsibilitiesManage and...
-
Boston, Massachusetts, United States Foundation Medicine Full timeAbout the RoleThe Senior Research Associate, Assay Development supports the development, design, and validation of Next Generation Sequencing (NGS)-based molecular diagnostic assays for internal and external research projects at Foundation Medicine. This role requires leveraging additional years of experience and/or education for a more advanced level of...
-
Senior Clinical Research Nurse
1 week ago
Boston, Massachusetts, United States Hebrew SeniorLife Full timePosition Overview The Clinical Research Nurse will play a crucial role in executing a significant intervention aimed at enhancing medication management within long-term care facilities as part of a comprehensive clinical study. This position will operate under the guidance of the Principal Investigator and requires a minimum of 5 years of nursing...
-
Senior Research Administrator
2 days ago
Boston, Massachusetts, United States New England College of Optometry Full timeJob DescriptionAbout the Role:The Senior Research Administrator will provide regulatory expertise, professional guidance, and administrative support to the Director of Research and Principal Investigators (PIs) to encourage and support the application for external research funding, and to ensure that such funding is used for authorized/allowable purposes in...
-
Senior Research Administrator
1 week ago
Boston, Massachusetts, United States New England College of Optometry Full timeJob Summary:The New England College of Optometry is seeking a highly skilled and experienced Senior Research Administrator to provide critical support to our faculty and staff in the development and management of research grants and contracts.Key Responsibilities:Pre-Proposal and Proposal Development Activities:Discuss early phases of project ideas with...
-
Senior Clinical Research Nurse
1 week ago
Boston, Massachusetts, United States Hebrew SeniorLife Full timePosition Overview The Clinical Research Nurse will play a crucial role in implementing a medication optimization initiative within skilled nursing facilities as part of a comprehensive clinical study. This position requires collaboration with the Principal Investigator and entails a minimum of five years of nursing experience, along with a valid nursing...