Research Regulatory Assistant

RIH Rhode Island Hospital; Rhode Island; On-site; USD 42,000 - 69,000; Full time

Job summary

Rhode Island Hospital is seeking a Regulatory Assistant to support regulatory tasks for Brown University Health research programs and to maintain regulatory integrity from approval through study closure.

The role requires a bachelor’s degree in life sciences, strong organizational and communication skills, and the ability to work with sponsors, investigators, and regulatory staff. You will prepare documents, coordinate regulatory submissions, and assist with sponsor visits.

Qualifications

• Bachelor’s degree in Applied or Life Sciences or related area, including courses in research methodologies. 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
• Detail-oriented and excellent organizational skills
• Strong self-starter
• Interpersonal skills
• Team-oriented
• Excellent oral and written communication skills
• Proficient in Microsoft Office and in various database applications
• 6 months - 1 year in direct clinical trial administration experience or relevant administrative experience preferred but not required.

Responsibilities

• Assist with the preparation and/or collection of study related regulatory documents, including CVs, MSAs, Financial Disclosure Forms, Conflicts 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 setup 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

Skills

Detail-oriented

Organizational skills

Self-starter

Interpersonal skills

Team oriented

Communication skills

Microsoft Office

Clinical trial databases

Education

Bachelor’s degree in Applied or Life Sciences

Tools

Microsoft Office Suite

Clinical Trial Management System

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

• Assist with the preparation and/ or collection of study related research required regulatory documents, including but not limited to:
  • CVso
  • MLso
  • Financial Disclosure Formso
  • Conflict of Interest Formso
  • FDA 1572o
  • 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 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

• BASIC KNOWLEDGE:
• 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 skillso
• Strong-self-starter
• Interpersonal skillso
• Team-orientedo
• Excellent oral and written communication skillso
• Proficient 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.

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 8:30am - 5pm

Work Shift: Day

Daily Hours: 8 hours

Driving Required: No

As Rhode Island's largest health system and private employer, Brown University Health is the state's premier provider of health services and includes the only Level I Trauma Center for southeastern New England. Today, more than 20,000 people work at Brown University Health and bring their unique skills, experiences, and compassion to their jobs every day. Formed in 1994, Brown University Health is a not-for-profit health system based in Providence, RI comprising three teaching hospitals of The Warren Alpert Medical School of Brown University: Rhode Island Hospital and its Hasbro Children's; The Miriam Hospital; and Bradley Hospital, the nation’s first psychiatric hospital for children; Newport Hospital, Saint Anne's Hospital and Morton Hospital, community hospitals offering a broad range of health services; Gateway Healthcare, the state’s largest provider of community behavioral health care; and Brown Health Medical Group, the largest multi-specialty practice in Rhode Island. Brown University Health is an equal opportunity employer that values diversity of cultural background, race, gender, age, religion, identity, ability, and perspectives - we are actively committed to a diverse workforce that represents the patients and community that we serve. We are invested in creating a respectful, inclusive, and equitable environment that supports the holistic well-being of our employees and their families. Join us and help build a healthier future for our patients - and for yourself.

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