Regulatory Specialists perform a wide variety of start-up activities integral to the successful submission and approval of essential regulatory documents.
Clinical Research Regulatory Specialist job details
Regulatory Specialists perform a wide variety of start-up 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, Contract Research Organizations (CRO) and Independent Review Boards(IRBs) and all internally generated information prepared by members of the research team. The regulatory specialist will perform study start-up tasks promptly and will maintain all regulatory documentation.
- Excellence and Consistency
- A Spirit of Collaboration and Innovation
- Respect for our Subjects, Sponsors and Team Members
- Respect for our Community
- Unimpeachable Ethics
- Submit regulatory packages to sponsors, CRO’s and IRB’s
- Maintain current information on Primary Investigators 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.
- Correct/revise information as appropriate.
- Ensure accurate and timely completion of all documents needed for submission to the sponsor, CRO and IRB.
- Ensure maintenance and annual update of providers’ CVs and licenses.
- Communicate issues to Director of Research 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.
Desired Skills and Qualifications:
- Regulatory experience required, paper and electronic
- 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.
- Experience with “Clinical Conductor” desired but required
- Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Internet Browsers
- 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
Quality of Life Research Centers offers a highly competitive benefits package including:
- Health Insurance
- Dental and vision
- Paid Time off
- 401K with employer match.
- Paid Holiday’s
- Continuing education reimbursement