Senior Clinical Research Regulatory Coordinator, Center for Clinical Investigation, Hybrid

GENERAL SUMMARY/OVERVIEW STATEMENT:

The Center for Clinical Investigation (CCI) provide research support for the BWH investigator community. The CCI i

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, Seriou

Adverse Event reports, to the appropriate regulatory agencies and offices.

• Prepares, maintains and organizes regulatory files for each assigned study in compliance federal and local regulation

including study sponsor requirement, 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 guideline

(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 institution

• 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 requirement

o Responsibilities of sponsor-investigators related to IND and IDE regulatory requirements and annual reporting to the

FDA

Clinical Trial Management

• Expertise in project management related to tracking and managing assigned new protocol start-up packet; 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 update

and ensure all start-up activities are completed

• Create and maintain tracking for all subsequent submissions to the SRC / IRB; protocol & consent amendments, all

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

• Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies /

offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when

applicable

• Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming

protocol, consent and amendments and applicable protocol training; 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 policie

• 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

• Present regulatory status for disease group portfolio at applicable research meeting

Qualifications

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 skill

o Consistent adherence to the department's call handling expectations and metric

o Outstanding telephone soft skills - voice, tone, courtesy

o Ability to represent the department in public venues.

• Strong attention to detail

o Excellent multi-tasking, organizational and time management skill

o Ability to manage multiple projects simultaneously, including both long-term and short-term project

• Demonstrated skills in critical thinking, organizational skills, problem solving, and ability to make appropriate independent

decisions.

• Able to adapt and/or thrive in high stress, fast paced environment

• Flexible, dependable

• Possess sound judgment

• Ability to analyze complex situation

• Excellent problem-solving skill

• Strong interpersonal skill

• 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

stakeholder

• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good

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.

EEO Statement

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. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in

the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of

employment.