Senior Clinical Research Regulatory Coordinator, Clinical Investigation

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

•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 federal and local regulations 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 guidelines (GCP), as well as with MGB clinical research policies. The compliance audit process includes but is not limited to:

oCommunicating with Principal Investigator (PI) and designated study staff,

oPerforming remote and onsite review of study regulatory and subject files,

oProviding education and study management support to the PI and research team,

oProviding a written report and assessment of noncompliance,

oCompleting 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:

oClinical Trials.gov registration and reporting requirement

oResponsibilities 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 updates 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

oConsistent adherence to the department's call handling expectations and metric

oOutstanding telephone soft skills - voice, tone, courtesy

oAbility to represent the department in public venues.

•Strong attention to detail

oExcellent multi-tasking, organizational and time management skill

oAbility 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

oAbility to motivate and support a team's vision

oAbility 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.
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