Summary:
Reporting to the Regulatory and Quality Manager of the Brown University Health Oncology Clinical Research Department (Adult and Pediatrics) and in collaboration with the department Director and Medical Directors supervises activities of subordinate professional and support regulatory staff of the Brown University Health Oncology Clinical Research department (LOCR).
Responsibilities:
Responsible for the supervision of daily oversight of LOCR regulatory compliance 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 LOCR. The position involves the supervision of the regulatory staff within the department and management of study related activities. This individual requires supervising with the Director and Manager of the department the regulatory timelines of document submission and implementation of processes to achieve an optimal turnaround on approvals and study start-up.
May coordinate and conduct weekly and monthly LOCR study start-up meetings.In addition may participate in reporting on study start-up and study maintenance timelines at monthly BUHCI disease specific meetings.
This position works closely with department management participates with leadership in the development implantation and management of divisional standard operating procedures (SOPs) guidelines processes and work instructions.May work with management to 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.
Attends and participates in monthly LOCR quality meetings. Assist in training of regulatory staff on new processes procedures and guidelines in response to audits and Corrective Action and Preventive Action Plans (CAPA plans).
Assist with training and supervising regulatory staff under supervision of the LOCR Regulatory & Quality Manager.
Provides assistance/ guidance to regulatory and compliance LOCR personnel. Assist management with the review and approve for submission documents including regulatory sponsor and cooperative group submissions for regulatory requirements as needed. Serve as regulatory 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.
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 senior management.
Assist with supervising the Regulatory and Quality employee activities including performance management and recruiting. Assist with staff workload assessments.
Assists with the coordination and facilitation of 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 LOCR 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 (including remote visits) Formal Audits Sponsor Audits and Close out Visits. Develop and maintain complete records of protocol approval status and annual reviews.Assists with the coordination of all required submissions related to protocol physicians and procedures to the protocol office-Regulatory Affairs.Ensures full compliance with the IRB committees.
Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct.
Performs other related duties as necessary.
Other information:
BASIC KNOWLEDGE:
Bachelor�s Degree in related field with a minimum of 5 years� experience in research studies or
Master�s Degree in public 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 organizational skills
Detail-oriented
Proficiency in Microsoft Office (Excel Power Point Outlook and Word).
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
SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire.
May require valid driver�s license where grant requires travel outside of hospital.
EXPERIENCE:
At least five 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