Brown University Health
SUMMARY: The Regulatory Assistant performs multiple tasks to meet compliance requirements in research. This position assists in overseeing clinical research regulatory requirements for the department and provides support in managing clinical trials. The Regulatory Assistant supports the department and clinical studies through the regulatory portion of the trial submission process, maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Regulatory Assistant works closely with other Regulatory Assistants and Regulatory Coordinators within the department.
Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate.
Responsibilities
Assist with the preparation and collection of study-related regulatory documents, including but not limited to CV, ML, financial disclosure forms, conflict of interest forms, FDA 1572, and delegation of authority/staff signature logs.
May collect signatures to ensure accuracy of study documents.
Receives and processes clinical trial external safety reports, including SUSARs.
May process and file IRB and RDC approvals; may update the Clinical Trial Management System.
May complete minor revisions to clinical trials, such as personnel updates or continuing reviews.
May assist with the preparation and set-up of sponsor visits, such as monitoring visits, site initiation visits, and close-out visits.
Liaises with regulatory staff, sponsors, investigators, and research team members.
Participates in study initiation visits and interim monitoring visits.
Performs other duties as assigned.
Minimum Qualifications
Bachelor’s degree in Applied or Life Sciences or related area, including courses in research methodologies and microcomputer systems. In lieu of a bachelor’s degree, an additional 2-3 years of experience may be substituted.
Knowledge of theory and techniques of research methodology.
Must possess the following skills:
Detail-oriented and excellent organizational skills.
Strong self-starter.
Interpersonal skills.
Team-oriented.
Excellent oral and written communication skills.
Proficient in Microsoft Office and various database applications.
Experience: 6 months - 1 year in direct clinical trial administration experience or relevant administrative experience preferred but not required.
The Regulatory Assistant should develop a general understanding of compliance requirements with federal, state, and/or local programmatic regulations within three months of employment.
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS: This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.
INDEPENDENT ACTION: This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments, as well as external agencies, including, but not limited to study sponsors, local and federal agencies. This person should also be able to work with outside monitors and work independently. He/she should be able answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.
SUPERVISORY RESPONSIBILITY: None.
EEO STATEMENT: Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor.
LOCATION: Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903.
WORK TYPE: Day.
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Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate.
Responsibilities
Assist with the preparation and collection of study-related regulatory documents, including but not limited to CV, ML, financial disclosure forms, conflict of interest forms, FDA 1572, and delegation of authority/staff signature logs.
May collect signatures to ensure accuracy of study documents.
Receives and processes clinical trial external safety reports, including SUSARs.
May process and file IRB and RDC approvals; may update the Clinical Trial Management System.
May complete minor revisions to clinical trials, such as personnel updates or continuing reviews.
May assist with the preparation and set-up of sponsor visits, such as monitoring visits, site initiation visits, and close-out visits.
Liaises with regulatory staff, sponsors, investigators, and research team members.
Participates in study initiation visits and interim monitoring visits.
Performs other duties as assigned.
Minimum Qualifications
Bachelor’s degree in Applied or Life Sciences or related area, including courses in research methodologies and microcomputer systems. In lieu of a bachelor’s degree, an additional 2-3 years of experience may be substituted.
Knowledge of theory and techniques of research methodology.
Must possess the following skills:
Detail-oriented and excellent organizational skills.
Strong self-starter.
Interpersonal skills.
Team-oriented.
Excellent oral and written communication skills.
Proficient in Microsoft Office and various database applications.
Experience: 6 months - 1 year in direct clinical trial administration experience or relevant administrative experience preferred but not required.
The Regulatory Assistant should develop a general understanding of compliance requirements with federal, state, and/or local programmatic regulations within three months of employment.
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS: This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.
INDEPENDENT ACTION: This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments, as well as external agencies, including, but not limited to study sponsors, local and federal agencies. This person should also be able to work with outside monitors and work independently. He/she should be able answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.
SUPERVISORY RESPONSIBILITY: None.
EEO STATEMENT: Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor.
LOCATION: Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903.
WORK TYPE: Day.
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