Research Regulatory Affairs Coordinator
Company Name:
Banner Health
About Banner Alzheimer''s Institute (BAI)
BAI was established in 2006 as Banner Health''s first Center of Excellence. Banner Health is one of the largest nonprofit health care systems in the United States. Our team is uniquely, passionately and strategically committed to ending Alzheimer''s without losing another generation and to providing an unparalleled model of care for families facing this devastating disease.
BAI is committed to improving people''s lives through excellent patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer''s research and care.
About Banner Health
Banner Health is a comprehensive, award-winning health system that includes 23 hospitals in seven western states (twelve in Arizona), primary care health centers, research centers, labs, physician practices and much more. Throughout our system, skilled, compassionate professionals use the latest technology to change the way care is provided. We offer a choice of nursing career paths where you can leverage your abilities to make a real difference for your patients - and real change in the health care industry!
This position provides regulatory support to physician and clinical investigators or research administration and the Institutional Review Board (IRB) involved in the conduct or approval of conduct of investigational drug and device clinical research projects within the division. Provides daily operational coordination for regulatory aspects of all sponsored, grant funded and investigator initiated research administered by the division. Serves as a professional resource for regulatory information, handles the submission of regulatory documents; maintains site source documents. Ensures coordination of research activities with clinical research nurses, research directors, Institutional Review Board Chair(s) and members and other internal stakeholders.
Essential Functions
Prepares and submits research applications and performs regulatory study start up activities, drafts and or edits informed consents and other related documents, assists Principal Investigators (PIs) with protocol and document development, provides ongoing continuation reports to the Institutional Review Board (IRB) which include adverse event reporting, study amendment reporting, and coordination of submission to respective IRB. Conversely, a coordinator working with the Institutional Review Board will review, recommend changes or corrections, and prepare study related submissions for review by the IRB.
Develops and maintains all regulatory documents including study amendments, recruiting material, continual reviews and safety reports per guidelines and regulations of the sponsor and the participating institution per IRB, FDA and other applicable Federal, State and local regulatory agencies.
Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB. Interacts on behalf of the physician investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments.
Responsible for the development and maintenance of the investigative site's study and regulatory documents and assures compliance with FDA's Good Clinical Practice guidelines. If employed as coordinator for the IRB, assures timely completion and filing of necessary Federal Wide Assurance (FWA) documentation with the Office for Human Research Protection (OHRP) and the annual report required by the Office of Research Integrity (ORI).
Functions as the established site point- person who provides information to the PI, Research director and study staff of submissions and approvals of study related documents. Maintains protocol status updates for pending and active projects. Functions as the site point-person for sponsors and Contract Research Organization's (CRO's) to provide requested documents throughout the study existence and at monitoring and auditing visits conducted at the sites. Will be available to participate in site initiation visits for review of site regulatory binders. May be designated as the point-person for audits by regulatory agencies (i.e. OHRP, ORI, and FDA).
Coordinates daily operational activities consistent with the needs of clinical research staff or the Institutional Review Board to ensure timely submission of all regulatory documents and requests of sponsors. Engages in core measures of customer service and provides a professional example of the conduct of medical research to ensure human subject protection.
May be required to conduct other administrative duties to support Research Directors or the Institutional Review Board Chair.
Minimum Qualifications
Knowledge of business, healthcare administration or related field as typically acquired through the completion of a Bachelor's degree. Experience as typically acquired through four years of research trial coordination. Knowledge of FDA regulations and a significant understanding and knowledge of commonly used concepts, practices and procedures within the regulatory arena. Working knowledge of Microsoft computer applications is required. Proven analytical skills required. Must be able to work with minimal supervision and prioritize multiple projects. Excellent human relations, organizational and communication skills are required.
Preferred Qualifications
Additional related education and/or experience preferred.
Date: 2014-05-23
Country: US
State: AZ
City: Phoenix
Postal Code: 85006
Category: Research - Positions
Job Type: Full-Time-FAEstimated Salary: $20 to $28 per hour based on qualifications.
Banner Health
About Banner Alzheimer''s Institute (BAI)
BAI was established in 2006 as Banner Health''s first Center of Excellence. Banner Health is one of the largest nonprofit health care systems in the United States. Our team is uniquely, passionately and strategically committed to ending Alzheimer''s without losing another generation and to providing an unparalleled model of care for families facing this devastating disease.
BAI is committed to improving people''s lives through excellent patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer''s research and care.
About Banner Health
Banner Health is a comprehensive, award-winning health system that includes 23 hospitals in seven western states (twelve in Arizona), primary care health centers, research centers, labs, physician practices and much more. Throughout our system, skilled, compassionate professionals use the latest technology to change the way care is provided. We offer a choice of nursing career paths where you can leverage your abilities to make a real difference for your patients - and real change in the health care industry!
This position provides regulatory support to physician and clinical investigators or research administration and the Institutional Review Board (IRB) involved in the conduct or approval of conduct of investigational drug and device clinical research projects within the division. Provides daily operational coordination for regulatory aspects of all sponsored, grant funded and investigator initiated research administered by the division. Serves as a professional resource for regulatory information, handles the submission of regulatory documents; maintains site source documents. Ensures coordination of research activities with clinical research nurses, research directors, Institutional Review Board Chair(s) and members and other internal stakeholders.
Essential Functions
Prepares and submits research applications and performs regulatory study start up activities, drafts and or edits informed consents and other related documents, assists Principal Investigators (PIs) with protocol and document development, provides ongoing continuation reports to the Institutional Review Board (IRB) which include adverse event reporting, study amendment reporting, and coordination of submission to respective IRB. Conversely, a coordinator working with the Institutional Review Board will review, recommend changes or corrections, and prepare study related submissions for review by the IRB.
Develops and maintains all regulatory documents including study amendments, recruiting material, continual reviews and safety reports per guidelines and regulations of the sponsor and the participating institution per IRB, FDA and other applicable Federal, State and local regulatory agencies.
Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB. Interacts on behalf of the physician investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments.
Responsible for the development and maintenance of the investigative site's study and regulatory documents and assures compliance with FDA's Good Clinical Practice guidelines. If employed as coordinator for the IRB, assures timely completion and filing of necessary Federal Wide Assurance (FWA) documentation with the Office for Human Research Protection (OHRP) and the annual report required by the Office of Research Integrity (ORI).
Functions as the established site point- person who provides information to the PI, Research director and study staff of submissions and approvals of study related documents. Maintains protocol status updates for pending and active projects. Functions as the site point-person for sponsors and Contract Research Organization's (CRO's) to provide requested documents throughout the study existence and at monitoring and auditing visits conducted at the sites. Will be available to participate in site initiation visits for review of site regulatory binders. May be designated as the point-person for audits by regulatory agencies (i.e. OHRP, ORI, and FDA).
Coordinates daily operational activities consistent with the needs of clinical research staff or the Institutional Review Board to ensure timely submission of all regulatory documents and requests of sponsors. Engages in core measures of customer service and provides a professional example of the conduct of medical research to ensure human subject protection.
May be required to conduct other administrative duties to support Research Directors or the Institutional Review Board Chair.
Minimum Qualifications
Knowledge of business, healthcare administration or related field as typically acquired through the completion of a Bachelor's degree. Experience as typically acquired through four years of research trial coordination. Knowledge of FDA regulations and a significant understanding and knowledge of commonly used concepts, practices and procedures within the regulatory arena. Working knowledge of Microsoft computer applications is required. Proven analytical skills required. Must be able to work with minimal supervision and prioritize multiple projects. Excellent human relations, organizational and communication skills are required.
Preferred Qualifications
Additional related education and/or experience preferred.
Date: 2014-05-23
Country: US
State: AZ
City: Phoenix
Postal Code: 85006
Category: Research - Positions
Job Type: Full-Time-FAEstimated Salary: $20 to $28 per hour based on qualifications.
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