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Job Details

Regulatory Research Specialist

Company name
Sheridan Healthcare, Inc.

Location
Plantation, FL

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Profile

Overview Envision Physician Services is a multispecialty physician group and practice management company. Established in 1953, our organization provides anesthesia, emergency medicine, hospital medicine, radiology, primary/urgent care, surgical services, and women’s and children’s health services to hospitals and health systems nationwide. Sheridan Healthcare, EmCare, Reimbursement Technologies and Emergency Medical Associates have recently joined forces to form Envision Physician Services.  As one organization, we now provide a greater scope of service than any other national physician group. Our collective experience from hundreds of local, customized engagements, culture of continuous lean process improvement, and team of experts in the business of healthcare enable us to better solve complex problems and consistently give healthcare organizations confidence in our execution. Our combined organization serves more than 780 healthcare facilities in 48 states and the District of Columbia. 

If you are looking for a stable, fast-paced, growing Company in the healthcare industry that is committed to innovation, excellence and integrity, then this may be a great next step in the advancement of your career.

We currently have an opportunity available at our corporate offices in Plantation, Fl for a

Regulatory Research Specialist

 The Regulatory Reseach Specialist Prepares all Regulatory Submission packages and Essential Documents for Institutional Review Board (IRB) for study start up, advertising, and assists with continuing review and study closure. Communicates frequently with Sponsors, Attorneys, and functions as a resource for physicians, and other members of the research team; communicates effectively to supervisor on study status and developments. Works on projects related to clinical trials and study tracking. Reviews and creates department monthly metrics. Stays abreast to current research regulatory updates and changes and communicates this to the staff. Held accountable for adhering to company Standard Operating Procedures (SOPs), regulatory guidelines, study start-up, tracking time, and reports any updates or changes to supervisor

This is a great opportunity for the right candidate!

Responsibilities Prepares Regulatory and Essential Documents for IRB Submission.

Prepares the delivery of new study packages to assist study feasibility for physicians and research coordinators and tracks time sensitive feedback.

Submits documents to legal for review prior to IRB submission.

Negotiates with Sponsor for proposed language for documents when applicable.

Coordinates study activities in conjunction with Director for contract negotiation and budgeting of new study protocols.

Remains current with FDA Regulations, Guidelines, and Good Clinical Practices and updates research staff and Investigators.

Prepares research sites for site initiation and communicates all current IRB Approvals and provides delivery of study materials to sites in time for study start dates.

Creates and submits advertising for IRB approval and placement for research sites when applicable.

Communicates with IRB and Sponsor on assigned protocols during Regulatory Submissions.

Participates in team meetings for assigned protocols and research related business.

Obtains, acknowledges and records shipment of Regulatory documents to the Sponsor, IRB, and Study Site.

Attends relevant conferences/meetings of the Sponsor pertaining to assigned protocol when applicable.

Tracks and prepares monthly status metrics for posting.

Communicates openly and often with Director, Study Team, and Investigators about regulatory landscape and new studies.

Reads and abides by the company’s code of conduct, ethics statements, employee handbook(s), policies and procedures and other corporate mandates, including participation in mandatory training programs.

Reports any real or suspected violation of the corporate compliance program, company policies and procedures, harassment or other prohibited activities in accordance with the reporting policies of the company.

Obtains clarification of policy whenever necessary and may use the resources available through the Compliance, Human Resources or Legal Department to do so.

Job Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Strong medical and research regulatory background with at least 2 years of research experience preferred

Able to effectively communicate with Sponsors, business associates, regulatory personnel, physicians, medical assistants/nurses and study coordinators

Good organizational skills; able to work independently

Able to interact as liaison between sponsors, business associates, regulatory personnel and supervises the regulatory climate of research sites and the various participating physicians, study coordinators, and ancillary research site personnel

Education/Experience:

Bachelor's degree from four-year College or University and 1 or more years related experience; or equivalent combination of education and experience

Computer Skills:

To perform this job successfully, an individual should have knowledge of:

Microsoft Word

MS Excel

Report Writing

Lotus Notes

Certificates and Licenses:

CCRC or other accredited research program

If you are ready to join an exciting, progressive company and have a strong work ethic,  join our team of experts!

 We offer a highly competitive salary and a comprehensive benefits package.

Envision Physician Services uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit  www.dhs.gov/E-Verify

Envision Physician Services

 is an Equal Opportunity Employer.

#CB

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Company info

Sheridan Healthcare, Inc.
Website : http://www.sheridanhealthcare.com

Company Profile
Sheridan is the nation's leading healthcare solutions provider for anesthesia services, emergency department services, neonatal management and radiology services. We actively partner with physicians, hospitals and ambulatory surgery centers to improve performance and reduce expenses while increasing patient satisfaction. Our collaborative approach and proven methodologies have served our clients since 1953.

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