Research Regulatory Assistant

Lifespan; Providence (RI); On-site; USD 41,537 - 68,556; Full time

Job summary

Brown University Health is seeking a Regulatory Assistant to support clinical trial regulatory activities from approval to closure at Rhode Island Hospital. You will help prepare regulatory documents, collect signatures, and handle safety reports within a collaborative team.

The role requires a life sciences background, strong organizational and communication skills, and proficiency with MS Office. The position is based in Providence, RI, with standard work hours.

Qualifications

• Bachelor's degree in Applied or Life Sciences or related area; substitution: 2–3 years of experience may be substituted.
• Knowledge of theory and techniques of research methodology.
• Detail-oriented, organized, self-starter, interpersonal, team-oriented with strong oral and written communication; proficient in MS Office and databases.

Responsibilities

• Assist with the preparation and collection of study-related regulatory documents (CVs, FDA 1572, disclosure forms, etc.).
• May collect signatures to ensure accuracy of study documents.
• Receive and process external safety reports, including SUSARs.
• Process and file IRB and RDC approvals; may update the Clinical Trial Management System.
• Assist with sponsor visits such as Monitoring, Site Initiation and Close-Out Visits.
• Liaise with regulatory staff, sponsors, investigators and the research team.
• Participate in Study Initiation Visits and Interim Monitoring Visits.
• Performs other duties as assigned.

Skills

Detail-oriented

Organizational skills

Self-starter

Interpersonal skills

Team oriented

Communication

Microsoft Office & databases

Education

Bachelor's degree in Applied or Life Sciences or related area

Tools

Microsoft Office

Database applications

Job description

SUMMARY

The Regulatory Assistant performs multiple tasks in order to meet compliance requirements in research. This position will be assisting in the overseeing of clinical research regulatory requirements for the department. The Regulatory Assistant will provide support in managing clinical trials for the department. The Regulatory Assistant supports the department and clinical studies through the regulatory portion of the trial submission process to 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

• white-space:preAssist with the preparation and/ or collection of study related research required regulatory documents, including but not limited to: o white-space:preCVso white-space:preMLso white-space:preFinancial Disclosure Formso white-space:preConflict of Interest Formso white-space:preFDA 1572o white-space:preDelegation of Authority/ Staff Signature Logs
• white-space:preMay collect signatures to ensure accuracy of study documents
• white-space:preReceives and processes clinical trial external safety reports, including SUSARs
• white-space:preMay process and file IRB and RDC approvals; may update the Clinical Trial Management System
• white-space:preMay complete minor revisions to clinical trials, such as personnel updates or continuing reviews
• white-space:preMay assist with the preparation and and set-up of sponsor visits, such as Monitoring Visits, Site Initiation Visits and Close-Out Visits
• white-space:preLiaises with regulatory staff, sponsors, investigators, and research team members
• white-space:preParticipates in Study Initiation Visits and Interim Monitoring Visits
• white-space:prePerforms other duties as assigned

MINIMUM QUALIFICATIONS

BASIC KNOWLEDGE

• white-space:preBachelor'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.
• white-space:preKnowledge of theory and techniques of research methodology
• white-space:preMust possess the following skills: o white-space:preDetail-oriented and excellent organizational skillso white-space:preStrong-self-startero white-space:preInterpersonal skillso white-space:preTeam-orientedo white-space:preExcellent oral and written communication skillso white-space:preProficient in Microsoft office and in 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 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

Pay Range

$41,537.60-$68,556.80

EEO Statement

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.

Location

Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903

Work Type

M-F 8:00am - 4:30pm

Work Shift

Day

Daily Hours

8 hours

Driving Required

No