- Prepare and submit applications, including preparation of consent forms to the IRB on all clinical trials (industry, cooperative groups and PI initiated studies), and respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients. (essential)
- Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols. Oversee reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance. Troubleshoot processes and procedures when issues are identified. (essential)
- 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 and local bio safety committees. (essential)
- Preparation and implementation of regulatory office SOPs and develops training materials and provides training to other regulatory staff. (essential)
- Preparation and implementation of regulatory office SOPs. (essential)
- Preparation, submission and activation of single patient IND protocols to the FDA and IRB. Interact with the FDA on emergency use of a test article without IRB review applications. (essential)
- Assist in preparation of FDA, cooperative group and NCI audits. Coordinate BIDMC participation in audits of clinical trials including internal audits, DFHCC audits, Network institution audits, Sponsor audits and audits conducted by federal, state and local regulatory authorities. (essential)
- Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. (essential)
- Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred.
- Minimum of 3-5 years related work experience required.
- Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines.
- Demonstrated ability to effectively manage staff and work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and seek supervisory assistance as appropriate.
- 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.
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Sr. Regulatory Specialist - Boston, United States - Beth Israel Lahey Health
Description
Job Type:
Regular
Time Type:
Full time
Work Shift:
Rotating (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.
Job Type:
Regular
Scheduled Hours:
32
Work Shift:
Rotating (United States of America)
The Sr.
Regulatory Specialist supports regulatory compliance for clinical research conducted by investigators in the department of emergency medicine at Beth Israel Deaconess Medical Center (BIDMC).
The position is flexible in terms of remote versus onsite work. A part-time opportunity is available.Job Description:
Primary Responsibilities:
Required Qualifications:
Competencies:
Decision Making:
Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
Problem Solving:
Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
Independence of Action:
Ability to follow precedents and procedures. May set priorities and organize work within general guidelines. Seeks assistance when confronted with difficult and/or unpredictable situations. Work progress is monitored by supervisor/manager.
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.Social/Environmental Requirements:
Work requires close attention to task for work to be accurately completed. Intermittent breaks during the workday do not compromise the work.
Work routine is fairly consistent, but employee needs to be able to use judgment to respond to events several times a week.
Health Care Status:
NHCW:
No patient contact.- Health Care Worker Status may vary by department.
Sensory Requirements:
Close work (paperwork, visual examination), Monitor Use, Visual clarity <3 feet, Conversation.
Physical Requirements:
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. This job requires frequent sitting, keyboard use.
FLSA Status:
Exempt
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.
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