Tewksbury, Massachusetts, United States
Develops and implements new and revised policies & procedures in consultation with the Director of Research Administration and Institutional Official; Provides guidance involving the interpretation of regulations, Federal and international guidance, and institutional policies to the organization’s IRB members, researchers, staff, and administrators; Determines appropriate path of escalation for any non-compliance issues; Serves as the Primary contact for all Ceded Reviews; Serves as the central point of collaboration for all components of the HRPP including planning and implementation; Responds to any research participant complaints; Works with the Research Quality Assurance Program to ensure compliance with all applicable policies and regulations; Establishes criteria for AAHRPP Accreditation
Reviews protocols and documents to identify regulatory issues and institutional policy issues; Determines which submissions qualify for expedited review; Provides guidance and training to investigators and research staff concerning federal research regulations, institutional requirements and IRB policies and procedures; Gathers information and material in response to inquiries and responds to requests for information regarding IRB review; Helps to provide educational materials for the IRB Members; Develops and revises Research Administration and IRB SOPs; Develops and revises application forms for IRB submissions; Conducts Expedited reviews and Exempt determinations of submitted research protocols and amendments; Directs management of IRB office staff of 3 employees; Ensures regulatory compliance with HIPAA, OHRP, and FDA regulations; Provides research compliance training to IRB staff, Committee members, and research staff on OHRP and FDA regulations; Documents minutes for Full Board meetings
Oversees assignment of reviewers, meeting with staff and Board Chairs prior to meetings to review the agenda; Provides social, behavioral and educational research (SBER) expertise to four separate Full Committee staff and Committee members; Provides supervisory oversight for the IRB review of Exempt and Expedited studies; Tracks the processing of Exempt and Expedited reviews and monitors review times to ensure that benchmarks are maintained; Ensures regulatory compliance with HIPAA and FERPA; Provides research compliance training to IRB staff and Committee members; Provides training to IRB staff, Committee members, and research staff on OHRP and FDA regulations; Develops internal SOPs for review and processing of studies; Manages all aspects of the IRB staff and office in the absence of the Director
Conducted assessment of research activities to ensure that they are planned, reviewed, and conducted in compliance with Federal and State Regulations and University policies and procedures; Performed technical pre-review of research applications with regard to protocol design, risk assessment, evaluation of review type, grant application, consent procedures, and study procedures; Monitored the Code of Federal Regulations, FDA, OHRP, and over-arching federal agencies for changes that affect research policies and procedures; Conducted pre-review of all protocol submissions reviewing them for content, accuracy, and completeness; Provided support to Investigators and study staff regarding Federal regulations and guidelines for conducting research; Met with medical student and post-doctoral investigators to assist in their preparation for conducting individual research projects; Prepared meeting minutes for assigned protocols sent to monthly full review IRB meetings; Conducted trainings for medical and dental students as well as Post-Doctoral employees; Provided technical support to ORSP staff.
Conducted assessment of research activities to ensure they are planned, reviewed, and conducted in compliance with VA, State, and Federal regulations; Worked in conjunction with Research Coordinator to conduct inspections of SOPs and policies of operational functions to determine compliance with laws, regulations, and principles guiding research; Monitored the Code of Federal Regulations, ORO, FDA, OHRP and other federal agencies for changes that affect research policies and procedures; Developed and coordinated record keeping and reporting capabilities with the Research Service for compliance issues; Created policies for ensuring compliance.
Compiled data and performed data entry, coding, and cleaning for analysis; Performed initial screening assessments and obtained psychiatric histories for patient recruitment into various research studies; Performed psychological testing in weekly assessments of patients participating in research studies; conducted weekly individual therapy sessions with participants; Presented informational training sessions for staff to facilitate referrals; Devised procedures for optimal participant recruitment and retention; Performed site preparation for new protocols.
Primary contact for caseload of 17 residents providing case management; Prepared and presented monthly, quarterly, and annual assessments of residents; Conducted intake evaluations of incoming residents; Provided individual therapy sessions with primary caseload focusing on specific diagnoses and behavioral issues; Conducted group therapy sessions on anger management, depression, substance abuse, borderline personality disorder, and other diagnoses; Developed teaching materials for group therapy sessions; Assisted staff Psychiatrist with separate caseload of patients, providing outreach and support regarding behavioral issues and medication changes.