Brigham and Women’s Hospital
Senior Clinical Research Regulatory Coordinator, Center for Clinical Investigati
Brigham and Women’s Hospital, Boston, Massachusetts, us, 02298
Job Description - Senior Clinical Research Regulatory Coordinator, Center for Clinical Investigation, Hybrid (3302525)
GENERAL SUMMARY/OVERVIEW STATEMENT:The Center for Clinical Investigation (CCI) provides research support for the BWH investigator community. The CCI is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women’s Hospital.The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director, and Principal Investigator(s) to complete the regulatory requirements of clinical research projects. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with Mass General Brigham policies as well as extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines.
PRINCIPAL DUTIES & RESPONSIBILITIES:
Regulatory Coordination• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.• Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies and offices.• Prepares, maintains and organizes regulatory files for each assigned study in compliance with federal and local regulations including study sponsor requirements, institutional requirements, and good clinical practice guidelines.• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third-party auditors.
Compliance and Education• Performs preparatory regulatory compliance audits of IRB-approved clinical research protocols at MGB institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), as well as with MGB clinical research policies.• Perform Study Start Up Assessments of clinical research protocols prior to study initiation.• Conduct consultations pre-audit and as needed/requested with investigators and study staff on human subject research.• Provide human research education at MGB institutions to large and small groups as assigned.• Assist with the development of study management tools and study document templates for use by the MGB research community.
Clinical Trial Management• Expertise in project management related to tracking and managing assigned new protocol start-up packets; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed.
Key Stakeholder Interfacing• Establishing and maintaining regular communication with the study team, study sponsor, and applicable regulatory agencies/offices to ensure all required information is relayed and responsible for the systematic documentation/tracking when applicable.
Leadership and Professionalism• Extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines, regulatory guidance and local policies.• Lead and collaborate with CCCI staff to implement regulatory and study based training and implementation of new or revised regulation, guidance, and/or local policy.
QUALIFICATIONS:Bachelor’s degree (BA, BS) required; Master’s or other advanced degree highly preferred. 3+ years of direct regulatory experience required. Must have expert knowledge of FDA and ICH/GCP guidelines. Previous experience with clinical trials and/or research coordination and personnel management required.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:- Respects the talent and unique contribution of every individual, culture and ethnic group and treats all people in a fair and equitable manner.- Values diversity, integrity and confidentiality.- Exercises self-awareness; monitors impact on others; is receptive to and seeks out feedback; uses self-discipline to adjust to feedback.- Accountable for delivering high quality work.- Commitment to ongoing learning to produce safe, effective, quality outcomes.- Strong communication and listening skills.- Strong attention to details.- Demonstrated skills in critical thinking, organizational skills, problem solving, and ability to make appropriate independent decisions.- Ability to work independently and as part of an interdisciplinary team.
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.
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GENERAL SUMMARY/OVERVIEW STATEMENT:The Center for Clinical Investigation (CCI) provides research support for the BWH investigator community. The CCI is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women’s Hospital.The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director, and Principal Investigator(s) to complete the regulatory requirements of clinical research projects. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with Mass General Brigham policies as well as extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines.
PRINCIPAL DUTIES & RESPONSIBILITIES:
Regulatory Coordination• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.• Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies and offices.• Prepares, maintains and organizes regulatory files for each assigned study in compliance with federal and local regulations including study sponsor requirements, institutional requirements, and good clinical practice guidelines.• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third-party auditors.
Compliance and Education• Performs preparatory regulatory compliance audits of IRB-approved clinical research protocols at MGB institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), as well as with MGB clinical research policies.• Perform Study Start Up Assessments of clinical research protocols prior to study initiation.• Conduct consultations pre-audit and as needed/requested with investigators and study staff on human subject research.• Provide human research education at MGB institutions to large and small groups as assigned.• Assist with the development of study management tools and study document templates for use by the MGB research community.
Clinical Trial Management• Expertise in project management related to tracking and managing assigned new protocol start-up packets; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed.
Key Stakeholder Interfacing• Establishing and maintaining regular communication with the study team, study sponsor, and applicable regulatory agencies/offices to ensure all required information is relayed and responsible for the systematic documentation/tracking when applicable.
Leadership and Professionalism• Extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines, regulatory guidance and local policies.• Lead and collaborate with CCCI staff to implement regulatory and study based training and implementation of new or revised regulation, guidance, and/or local policy.
QUALIFICATIONS:Bachelor’s degree (BA, BS) required; Master’s or other advanced degree highly preferred. 3+ years of direct regulatory experience required. Must have expert knowledge of FDA and ICH/GCP guidelines. Previous experience with clinical trials and/or research coordination and personnel management required.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:- Respects the talent and unique contribution of every individual, culture and ethnic group and treats all people in a fair and equitable manner.- Values diversity, integrity and confidentiality.- Exercises self-awareness; monitors impact on others; is receptive to and seeks out feedback; uses self-discipline to adjust to feedback.- Accountable for delivering high quality work.- Commitment to ongoing learning to produce safe, effective, quality outcomes.- Strong communication and listening skills.- Strong attention to details.- Demonstrated skills in critical thinking, organizational skills, problem solving, and ability to make appropriate independent decisions.- Ability to work independently and as part of an interdisciplinary team.
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.
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