Partners Healthcare System Boston , MA 02298
Posted 3 weeks ago
GENERAL SUMMARY/OVERVIEW STATEMENT:
The Center for Clinical Investigation (CCI) provide 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
and IRB review and approval.
Adverse Event reports, to the appropriate regulatory agencies and offices.
including study sponsor requirement, institutional requirements and good clinical practice guidelines.
study progress and completion.
Investigator, Industry Sponsors, and third-party auditors.
Compliance and Education
ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines
(GCP), as well as with MGB clinical research policies. The compliance audit process includes but is not limited to:
o Communicating with Principal Investigator (PI) and designated study staff,
o Performing remote and onsite review of study regulatory and subject files,
o Providing education and study management support to the PI and research team,
o Providing a written report and assessment of noncompliance,
o Completing follow up to ensure corrective actions are implemented and the needs of the study staff are fully addressed.
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
Assist with development of clinical research education, support, and outreach activities at MGB institutions
Provide education, support/guidance, and resources to MGB research teams regarding all aspects of human subject
research including:
o Clinical Trials.gov registration and reporting requirements
o Responsibilities of sponsor-investigators related to IND and IDE regulatory requirements and annual reporting to the
FDA
Clinical Trial Management
facilitate and monitor study start-up progress to ensure established benchmarks are met.
and ensure all start-up activities are completed
required safety reporting, all required deviation, violation, exceptions or other event reporting. Ensure various regulatory
reporting required are met; Study Sponsor, FDA, IRB etc.
Key Stakeholder Interfacing
offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when
applicable
protocol, consent and amendments and applicable protocol training; responsible for the systematic documentation /
tracking when applicable
Leadership and Professionalism
regulatory guidance and local policies
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:
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
o Consistent adherence to the department's call handling expectations and metrics
o Outstanding telephone soft skills - voice, tone, courtesy
o Ability to represent the department in public venues.
o Excellent multi-tasking, organizational and time management skills
o Ability to manage multiple projects simultaneously, including both long-term and short-term projects
decisions.
Able to adapt and/or thrive in high stress, fast paced environments
Flexible, dependable
Possess sound judgment
Ability to analyze complex situations
Excellent problem-solving skills
Strong interpersonal skills
Ability to work independently and as part of an interdisciplinary team
o Ability to motivate and support a team's vision
o Ability to work effectively and collaboratively with a wide range of staff and interdisciplinary teams, families and other
stakeholders
decision-making and judgment and have attention to detail and follow-through skills.
Demonstrated organization and time management/prioritization skills with the ability to work independently are required.
Must be proficient in the use of computers, Microsoft applications and databases.
Partners Healthcare System