Massachusetts Staffing
Sr. Regulatory Specialist - Clinical Research Coordinator Core
Massachusetts Staffing, Boston, Massachusetts, us, 02298
Sr. Regulatory Specialist
The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). Primary responsibilities include preparing and submitting applications to the IRB on all clinical trials, preparing and assisting 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. 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. Preparation and implementation of regulatory office SOPs and develops training materials and provides training to other regulatory staff. Preparation and implementation of regulatory office SOPs. 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. 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. Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. Required Qualifications: 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. Competencies: Decision Making, Problem Solving, Independence of Action, Written Communications, Oral Communications, Knowledge, Teamwork, Customer Service, Social/Environmental Requirements, Health Care Status, Sensory Requirements, Physical Requirements.
The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). Primary responsibilities include preparing and submitting applications to the IRB on all clinical trials, preparing and assisting 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. 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. Preparation and implementation of regulatory office SOPs and develops training materials and provides training to other regulatory staff. Preparation and implementation of regulatory office SOPs. 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. 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. Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. Required Qualifications: 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. Competencies: Decision Making, Problem Solving, Independence of Action, Written Communications, Oral Communications, Knowledge, Teamwork, Customer Service, Social/Environmental Requirements, Health Care Status, Sensory Requirements, Physical Requirements.