Regulatory Specialist - Stephenson Clinical Research
Regulatory Specialist - Stephenson Clinical Research
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Job Description
When you join the growing BILH team youre not just taking a job youre making a difference in peoples lives.
The Regulatory Specialist supports regulatory compliance for clinical research 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:
Bachelors degree required; Masters degree preferred in Regulatory Affairs.
13 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:
13 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 serviceoriented 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 COVID19 as a condition of employment. Learn more about this requirement.
More than 35000 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
Required Experience:
Unclear Seniority
Employment Type
Full-Time
