Beth Israel Deaconess Medical Center
Join to apply for the
Regulatory Specialist
role at
Beth Israel Deaconess Medical Center Join to apply for the
Regulatory Specialist
role at
Beth Israel Deaconess Medical Center Job Type:
Regular
Time Type:
Full time
Work Shift:
Day (United States of America)
FLSA Status:
Exempt
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.
The Regulatory Specialist supports regulatory compliance for clinical research in the Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC).
Job Description:
Essential Responsibilities:
Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients. Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols. Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance and troubleshoots processes and procedures when issues are identified. Assist investigators and study teams in preparing and submitting IND applications to the FDA. Preparation and submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials. Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. Assist in the preparation and implementation of regulatory office SOPs.
Required Qualifications:
Bachelor's degree required; Master's degree preferred in Regulatory Affairs. 1-3 years related work experience required. Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines. Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel. Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Preferred Qualifications:
1-3 years of clinical trial regulatory affairs experience preferred.
Competencies:
Written Communications:
Ability to communicate clearly and effectively in written English with internal and external customers.
Oral Communications:
Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
Knowledge:
Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
Teamwork:
Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.
Customer Service:
Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.
Physical Nature of the Job:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally.
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more about this requirement.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Legal Industries Hospitals and Health Care Referrals increase your chances of interviewing at Beth Israel Deaconess Medical Center by 2x Sign in to set job alerts for “Regulatory Specialist” roles.
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Regulatory Specialist
role at
Beth Israel Deaconess Medical Center Join to apply for the
Regulatory Specialist
role at
Beth Israel Deaconess Medical Center Job Type:
Regular
Time Type:
Full time
Work Shift:
Day (United States of America)
FLSA Status:
Exempt
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.
The Regulatory Specialist supports regulatory compliance for clinical research in the Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC).
Job Description:
Essential Responsibilities:
Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients. Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols. Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance and troubleshoots processes and procedures when issues are identified. Assist investigators and study teams in preparing and submitting IND applications to the FDA. Preparation and submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials. Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. Assist in the preparation and implementation of regulatory office SOPs.
Required Qualifications:
Bachelor's degree required; Master's degree preferred in Regulatory Affairs. 1-3 years related work experience required. Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines. Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel. Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Preferred Qualifications:
1-3 years of clinical trial regulatory affairs experience preferred.
Competencies:
Written Communications:
Ability to communicate clearly and effectively in written English with internal and external customers.
Oral Communications:
Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
Knowledge:
Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
Teamwork:
Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.
Customer Service:
Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.
Physical Nature of the Job:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally.
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more about this requirement.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Legal Industries Hospitals and Health Care Referrals increase your chances of interviewing at Beth Israel Deaconess Medical Center by 2x Sign in to set job alerts for “Regulatory Specialist” roles.
Regulatory Affairs Specialist - Principal Specialist
Medford, MA $90,000.00-$105,000.00 1 week ago Regulatory Review Specialist – Ambulatory Surgical Centers (ASC)
Medford, MA $90,000.00-$105,000.00 1 week ago Cambridge, MA $172,500.00-$249,166.66 21 hours ago Cambridge, MA $120,488.00-$205,632.00 1 week ago Compliance Associate, Financial Regulatory Affairs
Global Regulatory Affairs Chief of Staff
Boston, MA $208,200.00-$327,140.00 16 hours ago State Regulatory Affairs Specialist, Medicaid and Health Policy
Associate Director - Global Regulatory Lead, GI & Inflammation
Compliance Associate, Financial Regulatory Affairs
Boston, MA $74,200.00-$126,200.00 4 weeks ago Compliance Associate - Regulatory and Operational Compliance (Boutique Hedge Fund)
Boston, MA $90,000.00-$140,000.00 1 day ago Senior Manager, Regulatory Affairs, Operations
Regulatory Affairs CMC Expert - Biologics
Cambridge, MA $127,219.00-$190,828.00 1 month ago Greater Boston $55,000.00-$70,000.00 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr