Mgr Regulatory Clin Research - Brown University Health

Summary:

Reporting to the Director of Clinical Research Management manages the daily functions of the Center for Clinical Research Management(CCRM).

Responsibilities:

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Responsible for daily oversight of CCRM regulatory compliance and quality activities related to regulatory submissions study maintenance quality control audit preparation and response related to regulatory findings audit and CAPA follow-up and special projects related to efficiency and compliance within the regulatory department of CCRM. The position involves the oversight of the direct reports and management of study related activities. This individual requires managing the regulatory timelines of document submission and implementation of processes to achieve an optimal turnaround on approvals and study start-up. 

Reports study start-up timelines to the CCRM Director. Coordinate and conduct weekly and monthly CCRM regulatory and clinical study start-up meetings. In addition participates in reporting on study start-up and study maintenance timelines at bi-monthly CCRM team meetings. 

This position within CCRM leadership assumes a leadership role in the development implantation and management of department standard operating procedures (SOPs) guidelines processes and work instructions. Work with others in CCRM leadership to develop and implement new administrative support regulatory policies and procedures processes and SOPs/guidance documents and revaluate existing policies and procedures by conducting quality assurance (QA) and quality control (QC) checks.

Coordinates and conduct quarterly CCRM quality meetings. Identify recommend and implement where possible corrective actions for regulatory and other related processes. Work with CCRM leadership to verify implemented corrective actions are suitable and effective.

Review with CCRM leadership corrective and preventive action plans in response to quality audits to assure adequacy and provide feedback as needed. In response to various external and internal reports would work with CCRM leadership in drafting CAPA for their approval. Assist CCRM leadership in training of staff on new processes procedures and guidelines in response to audits and Corrective Action and Preventive Action Plans (CAPA plans). 

Advise CCRM leadership in the development of regulatory strategies and regulatory compliance for a portfolio of clinical trials sponsored by Cooperative Groups Industry and Investigator Initiated studies that are supported by the Center for Clinical Research Management.

Hire train and manage regulatory staff (including Clinical Research Coordinators) under supervision of the CCRM Director. Responsible for training of included but not limited to Regulatory Compliance Research Coordinators Research Lab Supervisors and personnel with regards to regulatory compliance and the conduct of human subjects research.

Manage and provide assistance/ guidance to regulatory staff. Review and approve for submission documents including regulatory sponsor and IIT submissions for regulatory requirements as needed. Serve as regulatory primary point of contact for assigned project(s) as needed.

Maintain up-to-date knowledge of regulatory requirements and communicate in a timely manner any updates that may impact the regulatory program.

Responsible for leading CCRM regulatory activities for assigned projects in line with ICH/GCP requirements department requirements and scientific and institution policies and procedures. 

Maintains knowledge of highly complex regulatory requirements up to current date contribute to preparation of new regulatory guidance wherever possible comment on draft regulatory guidance and communicate changes in regulatory information to project teams and CCRM leadership.

Manage CCRM staff activities including performance management and recruiting. Complete and report on staff workload assessments. Distribute workload to regulatory and clinical coordinator members. Manage and mentor the CCRM staff in study work.

Provide regulatory guidance and assistance to the CCRM leadership with regards to regulatory compliance.

Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Provides guidance to regulatory staff with submissions as needed.

Communicate to CCRM staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol exceptions continuing reports and amendments.

Continues to actively participate and support studies as needed. Participates in Pre- Study Selection Visits Study Initiation Visits Interim Monitoring Visits Formal Audits Sponsor Audits and Close out Visits. Develop and maintain complete records of protocol approval status and annual reviews. Coordinates all required submissions related to protocol physicians and procedures to the protocol office-Regulatory Affairs. Ensures full compliance with the IRB committees.

Performs other related duties as necessary.

Other information:

BASIC KNOWLEDGE:

Bachelor�s Degree in related field with a minimum of 5-7 years� experience in research studies or Master�s Degree in regulatory affairs or hospital administration desirable. Knowledge of Federal regulations pertaining to clinical research using human subjects.

Sound knowledge of all federal local and state guidelines pertaining to Clinical Research. 

Excellent knowledge of essential regulatory document collection and mandatory submissions/correspondence with industry authorities and Institutional Review Boards.

Strong problem-solving skills.

Excellent management and organizational skills.

Detail-oriented.

Proficiency in Microsoft Office (Excel Power Point Outlook and Word).

Experienced in using OnCore CTMS platform eReg and REDCap strongly preferred.

Highly effective verbal and writing skills required.

Ability to foster smooth communications and teamwork among clinical research faculty fellows and staff as well as external organizations necessary.

Preferred SoCRA (Society of Clinical Research Associates) certified or eligible to complete certification within 18 months of hire

EXPERIENCE:

A minimum 5-7 years of experience in research studies including regulatory and quality experience.

INDEPENDENT ACTION:

Performs independently within the department policies and practices.

SUPERVISORY RESPONSIBILITY:

Up to 20 FTEs

Brown University Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union

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