Clinical Research Coordinator - Regulatory processes
Purpose
Perform study specific regulatory processes across multiple sites (approximately 20) and multiple studies and different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOP's), and study specific protocols/plans and processes. Assist in the development and implementation of policy and procedures and implementation of committee decisions and maintain accurate and complete records. Promote the ethical conduct of research and ensure compliance with federal, state, and institutional regulatory requirements. Additionally assist with data management related activities in the network
JOB RESPONSIBILITES
The following description of job responsibilities and standards reflects the major duties of the job but does not describe minor duties or other responsibilities that are assigned from time to time.
Clinical Quality and Internal Business:
A. Create and update clinical trials database for studies pending, and hold primary responsibility for moving studies through this process (approximately 15 at any given time point).
B. Assist in the coordination of non-treatment trials as provided by Duke Faculty members for network engagement.
C. Prepare documents for CPC and IRB submission for industry protocols not opened at Duke. This includes developing consent forms that comply with federal and local guidelines.
D. Coordinate the development and oversee implementation of study specific safety data reconciliation processes of moderate to complex nature across the DON sites.
E. Assist with regulatory audits at clinical and affiliate sites. Assure compliance of general and study specific regulatory processes with SOP's, FDA, NIH, and global regulations. Develop work plans to address findings.
F. Assist with the completion of new Affiliate site's cooperative group application.
G. Determine from monthly cooperative group protocol web postings, CTSU bi-monthly postings, investigator-initiated protocols and industry protocols which protocol activations, closures, and amendments are to be processed for the Duke Cancer Network (DCN) Sites.
H. Coordinate with DCN Research Staff which newly activated studies are to be opened at institution.
I. Maintain Certificate of Insurance from each site and obtain study/site specific waivers when indicated.
J. For newly activated protocols, prepare submission materials for initial submission to sites for approval. This would include Clinical Research Collaboration Agreements and Individual Protocol Agreements.
K. Prepare documents to notify sites of protocol closures as they occur.
L. Maintain annual IRB approvals for those studies that have patients remaining in follow-up status.
M. Prepare, submit, and ensure review of documents to sites for any protocol amendments.
N. Prepare, submit, and ensure review of documents to sites for renewal of protocols on at least an annual basis.
O. Maintain IRB records for each protocol including initial approval, amendments, annual reviews, serious adverse event reports, consent form, and other regulatory correspondence in accordance with FDA, sponsor and ICH guidelines. On average, this includes approximately 50 protocols.
P. Maintain primary responsibility of variety of regulatory tasks documented via the following databases: Working study list, IRB status of studies/approvals, clinical and affiliate site data queries,
Q. Maintain up-to date essential DCN staff documents (Approximately 480 documents including CV's, licenses, site laboratory certifications, NCI investigator numbers, and Human Protections Training for DON personnel).
R. Maintain database of studies and IRB status/approval.
S. Maintain QA databases to ensure protocols and all other essential documents are up to date.
T. Create QA reports as requested.
U. Create forms, databases and other tools as appropriate
Work Culture
A. Attend educational workshops and seminars as able to maintain current knowledge of federal regulations and compliance standards.
B. Assist with maintenance of Policies and Procedures for the Clinical Research Program.
C. Ensure that all new DCN personnel are registered with the NCI (physicians only), apply for cooperative group membership, complete Human Protections Training with the Duke Institutional Review Board, and added to the email list serves. This would include DCN physicians, extenders, new HPAs, new pharmacists, and new IRB chairs/members.
D. Develop and maintain mechanism(s) to inform physicians and staff of available protocols for their patient population
E. Educate physicians, nursing staff, etc. about pertinent changes in protocols as they occur, especially for studies with patients on active treatment.
F. Serve as a resource for questions and problems related to cooperative groups and other clinical oncology research.
Customer Service
A. Serve as a resource for questions and problems related to clinical research regulatory and compliance for staff at DCN Administrative Office as well as the DCN clinical and affiliate sites.
B. Assist study monitors as needed during site visits with regulatory document reviews.
C. Serve as the primary contact for CROs and/or Sponsors for all regulatory and compliance issues.
D. Serve as the primary contact for the Duke IRB, the regulatory coordinators at Duke, the Human Protections Administrators or Regulatory Managers, and the Local Research Review Committees/IRBs at the DCN sites.
E. Collaborate with Duke clinical research staff for educational and study operations.
F. Maintain liaison with investigators, industry representatives, research personnel, and staff to solve specific operating problems and improve technical activities, including, but not limited to staff and physicians of: Duke Cancer Network, Division of Medical Oncology, Department of Radiation Oncology, Duke Cancer Institute , Duke University Hospital, PDC, affiliate institutions, and local nursing and medical staffs
G. Participate as part of DCN team in cooperative group meetings
H. Develop and present educational programs related to regulatory functions
Finance
A. Follow DUHS financial policies for travel and expenses.
B. Appropriately utilize resources for education and quality assurance of affiliate sites and personnel.
C. Identify regulatory budget impact for annual budget.
Knowledge/Skills/Abilities (Preferred)
Certification in Clinical Research strongly recommended (SOCRA).
Experience in the area of regulatory compliance
Knowledge/experience in clinical research
Knowledge of HHS and FDA human protection regulations
Excellent organizational and verbal and written communication skills
Proficiency with computer software including word processing and databasesDuke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Education
Work requires graduation from an accredited degree program in a clinical field such as a BSN, Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents: 1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare, clinical and/or research experience; or 2. Completion of a bachelor's degree in a field related to health science plus a minimum of three years closely related clinical and/or research experience.
Experience
None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Degrees, Licensures, Certifications
N/A
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Perform study specific regulatory processes across multiple sites (approximately 20) and multiple studies and different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOP's), and study specific protocols/plans and processes. Assist in the development and implementation of policy and procedures and implementation of committee decisions and maintain accurate and complete records. Promote the ethical conduct of research and ensure compliance with federal, state, and institutional regulatory requirements. Additionally assist with data management related activities in the network
JOB RESPONSIBILITES
The following description of job responsibilities and standards reflects the major duties of the job but does not describe minor duties or other responsibilities that are assigned from time to time.
Clinical Quality and Internal Business:
A. Create and update clinical trials database for studies pending, and hold primary responsibility for moving studies through this process (approximately 15 at any given time point).
B. Assist in the coordination of non-treatment trials as provided by Duke Faculty members for network engagement.
C. Prepare documents for CPC and IRB submission for industry protocols not opened at Duke. This includes developing consent forms that comply with federal and local guidelines.
D. Coordinate the development and oversee implementation of study specific safety data reconciliation processes of moderate to complex nature across the DON sites.
E. Assist with regulatory audits at clinical and affiliate sites. Assure compliance of general and study specific regulatory processes with SOP's, FDA, NIH, and global regulations. Develop work plans to address findings.
F. Assist with the completion of new Affiliate site's cooperative group application.
G. Determine from monthly cooperative group protocol web postings, CTSU bi-monthly postings, investigator-initiated protocols and industry protocols which protocol activations, closures, and amendments are to be processed for the Duke Cancer Network (DCN) Sites.
H. Coordinate with DCN Research Staff which newly activated studies are to be opened at institution.
I. Maintain Certificate of Insurance from each site and obtain study/site specific waivers when indicated.
J. For newly activated protocols, prepare submission materials for initial submission to sites for approval. This would include Clinical Research Collaboration Agreements and Individual Protocol Agreements.
K. Prepare documents to notify sites of protocol closures as they occur.
L. Maintain annual IRB approvals for those studies that have patients remaining in follow-up status.
M. Prepare, submit, and ensure review of documents to sites for any protocol amendments.
N. Prepare, submit, and ensure review of documents to sites for renewal of protocols on at least an annual basis.
O. Maintain IRB records for each protocol including initial approval, amendments, annual reviews, serious adverse event reports, consent form, and other regulatory correspondence in accordance with FDA, sponsor and ICH guidelines. On average, this includes approximately 50 protocols.
P. Maintain primary responsibility of variety of regulatory tasks documented via the following databases: Working study list, IRB status of studies/approvals, clinical and affiliate site data queries,
Q. Maintain up-to date essential DCN staff documents (Approximately 480 documents including CV's, licenses, site laboratory certifications, NCI investigator numbers, and Human Protections Training for DON personnel).
R. Maintain database of studies and IRB status/approval.
S. Maintain QA databases to ensure protocols and all other essential documents are up to date.
T. Create QA reports as requested.
U. Create forms, databases and other tools as appropriate
Work Culture
A. Attend educational workshops and seminars as able to maintain current knowledge of federal regulations and compliance standards.
B. Assist with maintenance of Policies and Procedures for the Clinical Research Program.
C. Ensure that all new DCN personnel are registered with the NCI (physicians only), apply for cooperative group membership, complete Human Protections Training with the Duke Institutional Review Board, and added to the email list serves. This would include DCN physicians, extenders, new HPAs, new pharmacists, and new IRB chairs/members.
D. Develop and maintain mechanism(s) to inform physicians and staff of available protocols for their patient population
E. Educate physicians, nursing staff, etc. about pertinent changes in protocols as they occur, especially for studies with patients on active treatment.
F. Serve as a resource for questions and problems related to cooperative groups and other clinical oncology research.
Customer Service
A. Serve as a resource for questions and problems related to clinical research regulatory and compliance for staff at DCN Administrative Office as well as the DCN clinical and affiliate sites.
B. Assist study monitors as needed during site visits with regulatory document reviews.
C. Serve as the primary contact for CROs and/or Sponsors for all regulatory and compliance issues.
D. Serve as the primary contact for the Duke IRB, the regulatory coordinators at Duke, the Human Protections Administrators or Regulatory Managers, and the Local Research Review Committees/IRBs at the DCN sites.
E. Collaborate with Duke clinical research staff for educational and study operations.
F. Maintain liaison with investigators, industry representatives, research personnel, and staff to solve specific operating problems and improve technical activities, including, but not limited to staff and physicians of: Duke Cancer Network, Division of Medical Oncology, Department of Radiation Oncology, Duke Cancer Institute , Duke University Hospital, PDC, affiliate institutions, and local nursing and medical staffs
G. Participate as part of DCN team in cooperative group meetings
H. Develop and present educational programs related to regulatory functions
Finance
A. Follow DUHS financial policies for travel and expenses.
B. Appropriately utilize resources for education and quality assurance of affiliate sites and personnel.
C. Identify regulatory budget impact for annual budget.
Knowledge/Skills/Abilities (Preferred)
Certification in Clinical Research strongly recommended (SOCRA).
Experience in the area of regulatory compliance
Knowledge/experience in clinical research
Knowledge of HHS and FDA human protection regulations
Excellent organizational and verbal and written communication skills
Proficiency with computer software including word processing and databasesDuke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Education
Work requires graduation from an accredited degree program in a clinical field such as a BSN, Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents: 1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare, clinical and/or research experience; or 2. Completion of a bachelor's degree in a field related to health science plus a minimum of three years closely related clinical and/or research experience.
Experience
None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Degrees, Licensures, Certifications
N/A
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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