Sr Research Regulatory Coordinator 1 Job Providence area,Rhode Island USA,Healthcare

Summary

The Sr. Research Regulatory Coordinator is responsible for 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 Sr. Research Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Sr.

Research Regulatory Coordinator will provide support in managing the clinical trials within the department, instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries. The Sr. Research Regulatory Coordinator shall work closely with department leadership.

Summary

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

Develops protocols with the Principle Investigator and provides recommendations on research plan
Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.
Prepare and maintain study specific regulatory binder(s) and documents
Serves as the regulatory subject matter expert through all phases of a clinical study, including regulatory documents and/or processes related to clinical trials conduct
Initiates and leads special projects, to include process improvement and regulatory training
Ensures proper regulatory compliance in accordance with sponsoring agency requirements
Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines

Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Manages the preparation of annual reports to the FDA, as necessary. Manages and updates clinical trial/ study information located on the clinical trials.gov website, as needed.
Ensuring the collection and maintenance of credentialing information for study personnel. Such include conflict of interest forms (COI), CV’s, MLs, HSP and GCP training.
Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses.
Assist with training of all regulatory affairs personnel with regards to regulatory compliance. Act as a mentor for new employees and find ways to improve the department’s mentorship program.
Work directly with department leadership to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems.
Compile regulatory-related metrics for use by department…