SENIOR IRB ANALYST School of Medicine Clinical Research
2 weeks ago
The Sr. IRB Analyst provides administrative and regulatory support for the IRB staff, the IRB Chairs, the IRB Board members and the institution’s researchers. The Sr. IRB Analyst processes IRB submissions, serves as an alternate voting member on the IRB. The Sr. Analyst is designated by the IRB Chair as an Expediter to sign off on IRB expedited reviews. The IRB Chairs and Board members rely heavily on the regulatory knowledge and expertise of the Senior IRB Analysts to guide their reviews and decisions.
Other duties include:
Provides direct instructions, support, and regulatory guidance to researchers regarding IRB submissions and the INSPIR system. Provides support and assistance to investigators for individual IRB protocols, answering their questions and advising them about the Federal regulations and institutional policies. Performs regulatory analysis and administrative review of IRB submissions to ensure compliance with Federal research regulations and institutional policies (Including new submissions, renewals, amendments, AEs, deviations). Maintains documentation in accordance with Federal regulations and institutional policies. The Senior IRB Analyst can, at the direction of the Board Chair, independently review and approve Expedited and Exempt protocols and submissions (including new protocols, Progress Reports, Amendments, Deviations, AEs and Exceptions.) Prepares protocols for full Board review at IRB meetings and assists junior staff with full board meeting preparation; scheduling of meetings, pre-review of protocols, assigning protocols to reviewers, documenting review, processing modification memos, communicating with the Chair, providing regulatory advice, ensuring regulatory compliance, recording meeting minutes.
Required Skills
Bachelor's Degree and 3+ years of direct IRB experience Master's Degree preffered Certified IRB Professional (CIP) certification will be required within 1 year of becoming eligible.Please note all newly hired staff and faculty will need to be in compliance with Boston University’s COVID-19 Vaccination and Booster Requirement within 30 days of date of hire. You must upload your vaccine documentation or request a medical or religious exemption (instructions). For further information on the University’s response to COVID-19, please visit the COVID-19 Resources site.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, natural or protective hairstyle, religion, sex, age, national origin, physical or mental disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or because of marital, parental, or veteran status. We are a VEVRAA Federal Contractor.
KN
Required Experience
Qualifications:
Please note all newly hired staff and faculty will need to be in compliance with Boston University’s COVID-19 Vaccination and Booster Requirement within 30 days of date of hire. You must upload your vaccine documentation or request a medical or religious exemption (instructions). For further information on the University’s response to COVID-19, please visit the COVID-19 Resources site.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, natural or protective hairstyle, religion, sex, age, national origin, physical or mental disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or because of marital, parental, or veteran status. We are a VEVRAA Federal Contractor.
KN
-
Clinical Research Coordinator Senior
3 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,...
-
Research Assistant I
1 month ago
Boston, United States DM Clinical Research Full timeJob DescriptionJob DescriptionResearch Assistant I The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials. DUTIES & RESPONSIBILITIESCompleting DMCR-required training, including GCP and IATA.Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational...
-
Senior 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 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...
-
MGH Emergency Medicine Clinical Research Coordinator
2 months ago
Boston, Massachusetts, United States Massachusetts General Hospital Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT:The Massachusetts General Hospital Department of Emergency Medicine's division of research is seeking a highly motivated individual to assist with ongoing and future clinical research studies. Through participation in a variety of federally funded and industry sponsored clinical trials, our division aims to find new and...
-
Director of Clinical Research
4 weeks ago
Boston, United States Institute Of IT Trainings Full timeAbout UsInStride Health's mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance–based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research–backed clinical care and...
-
Director of Clinical Research
3 weeks ago
Boston, Massachusetts, United States Institute Of IT Trainings Full timeAbout UsInStride Health's mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance–based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research–backed clinical care and...
-
Clinical Research Nurse in Anesthesia
6 days ago
Boston, Massachusetts, United States Boston Childrens Hospital Full timePosition Overview:The Clinical Research Nurse will play a pivotal role in overseeing various clinical research initiatives within the Department of Anesthesiology, Critical Care, and Pain Medicine. This includes conducting research studies in both Operating Rooms and Intensive Care Units (ICUs).Key Responsibilities:1. Collaborate with the research team at...
-
Clinical Research Nurse, Anesthesia
3 months ago
Boston, United States Boston Children's Hospital Full time75396BRAnesthesiaJob Posting DescriptionThe Research Nurse will:Manage multiple clinical research projects for the Department of Anesthesiology, Critical Care and Pain Medicine, including research studies in the Operating Rooms and ICUsWork as part of the research team for the Pediatric Anesthesia Research CenterSubmit protocols, amendments, renewals and...
-
Research Compliance/Program Administrator
2 weeks ago
Boston, United States Joslin Diabetes Center Full timeOverview Under the supervision of the Director, Research Compliance/Assurance & Programs the Research Compliance/Program Administrator ((IRB/HRPP & FCOI) is responsible for ensuring Joslin’s IRB/Human Subject Protection Program (HRPP) and Research Financial Conflict of Interest (FCOI) Program adheres to federal, state and local regulations as well as...
-
Clinical Research Nurse, Anesthesia
1 week ago
Boston, United States Boston Children'S Hospital Full time75396BRIs this the role you are looking for If so read on for more details, and make sure to apply today.AnesthesiaJob Posting DescriptionThe Research Nurse will:Manage multiple clinical research projects for the Department of Anesthesiology, Critical Care and Pain Medicine, including research studies in the Operating Rooms and ICUsWork as part of the...
-
Clinical Research Nurse, Anesthesia
1 week ago
Boston, United States Boston Children's Hospital Full time75396BRAnesthesiaJob Posting DescriptionThe Research Nurse will:Manage multiple clinical research projects for the Department of Anesthesiology, Critical Care and Pain Medicine, including research studies in the Operating Rooms and ICUsWork as part of the research team for the Pediatric Anesthesia Research CenterSubmit protocols, amendments, renewals and...
-
Boston, United States Boston University Full time```html Job Responsibilities Manage research applications and awards at the School of Dental Medicine including 10 departments and two centers. Directly support 5-8 investigators in their grants management. Oversee, manage and problem-solve grant accounting issues. Provide pre & post-award support for the fiscal management of the assigned research grant...
-
Clinical Research Nurse, Anesthesia
2 weeks ago
Boston, United States Boston Children's Hospital Full timeJob Posting Description At Boston Children's Hospital, the quality of our care - and our inclusive hospital working environment - lies in the diversity of our people. With patients from local communities and 160 countries around the world, we're committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here,...
-
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...
-
Boston, 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 Technician
3 months ago
Boston, United States Tufts Medicine Full timeJob OverviewThis position assists in planning and implementing clinical research studies as assigned. Works directly with patients and their families providing a wide range of state-of-the-art imaging. Performs a variety of screening and technical diagnostic tests and facilitates all implementation phases of new studies and the ongoing coordination and...
-
Research Assistant II, General Internal Medicine
1 month ago
Boston, Massachusetts, United States Boston Medical Center Full timeResearch Assistant II, General Internal MedicineLocation: Boston, MASchedule: 40 hours per week, on-siteABOUT BMC:At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our...
-
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...
-
Boston, Massachusetts, United States Tufts Medicine Full timeWe're saving lives, building careers, and reimagining healthcare. We can't wait to grow alongside you. The Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center in Boston is seeking a full-timeacademic Infectious Diseases specialistwith significant experience in clinical and/or translational research to lead the Divisional research...
-
Clinical Research Specialist III
6 days 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...
