What are the responsibilities and job description for the Regulatory Specialist position at Alliance For MultiSpecialty Research LLC?
Position Overview
Regulatory Specialists perform a wide variety of activities integral to the successful submission and approval of essential regulatory documents. The regulatory specialist is responsible for collecting all regulatory documentation, all correspondence from the various sponsors/CRO’s and IRBs and all internally generated information prepared by members of the research team. The regulatory specialist will perform study tasks promptly and will maintain all regulatory documentation.
Position type: Remote
To consistently embody AMR’s Core Values:
- Excellence and Consistency
- Collaborative Innovation
- Respect for our Subjects, Sponsors and Team Members
- Community
- Unimpeachable Ethics
The Regulatory Specialist reports to the Senior Director of Regulatory Operations, Regulatory Director, and Senior Vice President of Operations.
Classification: Non-Exempt
Primary Responsibilities:
- Maintain current information of PI and Sub-Investigators.
- Maintain communication with sponsors, CROs and IRB’s.
- Submit and maintain all IRB related information.
- Enter information into the computer systems as appropriate.
- As needed, meet with sponsor’s monitors during site visits, by phone, email, WebEx, or in person.
- Correct/revise regulatory information as appropriate.
- Ensure accurate and timely completion of all documents needed for submission to the sponsor, CRO and IRB.
- Ensure maintenance and biennially update of all staff’s CVs and & annual providers licenses.
- Communicate issues to the site manager, site GM, Senior Director of Regulatory Operations/Regulatory Director in a timely manner.
- Research and apply all federal Food and Drug Administration (FDA) regulations and guidelines to ensure compliance with federal law. Ensure completion of training and testing if applicable.
- Provide quality service to all Sponsors, CROs and IRBs in a timely manner; whether in person, by phone or email.
- At all times ensure the safety and welfare of study participants.
- Other duties as assigned
Desired Skills and Qualifications:
- 1 year professional office experience required
- Willingness to work in a fast-paced environment where processes change and improve continually.
- Able to function independently without constant supervision and adapt to change.
- Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach.
- Ability to effectively devote keen and acute attention to detail.
- Clinical Conductor experience preferred, but not required
- Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Internet
- Professional and highly motivated “self-starter” with the ability to exercise initiative.
- Excellent task management and prioritization skills.
- Strong verbal and interpersonal skills.
- Excellent follow up
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
