TAMARA BUBB, MS, ACRP-CP
Spring Grove,PA
Summary
Experienced Compliance Specialist with a strong background in clinical research spanning over 18 years, including 15 years focused specifically on research compliance oversight and enforcement. Managed clinical trials across multiple protocols and sites, working closely with principal investigators and study teams to ensure regulatory adherence and operational efficiency. Skilled in ensuring study compliance with local and federal regulations, including FDA requirements, ICH-GCP guidelines, and institutional policies. Conduct in-services, develop comprehensive training materials, and provide ongoing education to research personnel to promote a culture of compliance. Actively support and participate in internal audits and FDA inspections, preparing audit-ready documentation and facilitating timely, effective responses. Adept at organizing regulatory documents, maintaining site binders, and overseeing data integrity throughout the study lifecycle. Consistently meet aggressive deadlines while producing high-quality, accurate data that supports reliable research outcomes.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Compliance Specialist - Research Quality Assurance
Pennsylvania State University - College of Medicine
07.2016 - Current
- Review human research protocols for compliance with governmental regulations and University policy, initiate clear and accurate written correspondence and/or telephone contact with investigators and staff, and request clarification and/or additional information to enable sound judgments to ensure compliance ensure safety at investigative sites by verifying proper recording and reporting of Serious Adverse Events (SAEs)
- Reviews federal and state requirements, research protocols, and other government, local, and University mandates to ensure that The University and its employees are in compliance with these regulations
- Perform ancillary IND/IDE request for guidance reviews as required by The Institutional Review Board.
- Maintain appropriate documentation of compliance reviews and determinations as required by federal regulations and by University policy
- Initiates investigations and/or routine audits for program compliance and/or in response to reports of non-compliance or concerns
- Responds to notifications of unsafe conditions, contract non-compliance, or other discrepancies and reports findings to compliance committees, administration, federal agencies and/or other mandated entities, as required and/or appropriate
- Consults and interacts with other institutions, federal agencies and other entities outside of The University to discuss best practices, common concerns, or regulation interpretation
- Serves on University, professional, and/or governmental advisory groups, committees or organizations
- Directs and implements strategic improvement plans to integrate solutions to audit findings and workflow process issues
- Interact with other University compliance committees and The Office of Research Protection at University Park, Office of Sponsored Programs, Office of General Counsel, Office of Information Security, and faculty and/or staff.
- Assist faculty, students and staff in preparing human research protocols for compliance certification, develop and maintain IRB training materials, present seminars/workshops at University Park, The College of Medicine, and other campus locations to faculty, staff and students about regulations and policies governing human participants involved in research at Penn State, and review, prepare, and facilitate agreements for IRB reliance
- Monitors safety programs to verify compliance with federal standards
- Implements electronic data capturing systems to adhere with clinical research guidelines
- Experienced in supporting FDA inspections by ensuring all study documentation is audit-ready and compliant with regulatory requirements. Actively participate in inspection preparation, interview coordination, and real-time response to FDA inquiries. Provide post-inspection follow-up by addressing findings, implementing corrective actions, and maintaining continuous compliance across research activities.
- Conduct thorough document reviews to ensure completeness, accuracy, and alignment with FDA submission requirements. Prepare detailed reports and verify critical data points to maintain consistency and regulatory compliance. Oversee data entry and collection processes to ensure high-quality information is compiled and ready for submission through the FDA’s NextGen Portal.
CCRA Post Approval Compliance Monitor
Clinical RM (WRAIR)
11.2015 - 03.2016
- Write and distribute time sensitive site visit reports, track resolutions of outstanding issues, and ensure compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), study protocol and overall research objectives
- Reviewed regulatory documents and assess completeness and compliance with regulatory requirements
- Conducted training sessions for site personnel on GCP and study protocol requirements
- Participated in project planning and continuing education
- Communicated and coordinated with research teams and HSPB colleagues to ensure transparency of compliance findings, training, and future requirements
- Employee was required to attend safety training relative to his/her position and report any infractions of safety procedures to facility.
Compliance Monitoring Specialist/JHM Office of Human Subjects
The Johns Hopkins University School Of Medicine
09.2011 - 11.2015
- Developed policies and standards to guide Principal Investigators (PI) and /or its representatives with regards to clinical trial activities
- Ensured that researchers adhere to JHMI privacy and confidentiality policies including The Health Insurance Portability and Accountability Act of 1996 (HIPAA), and The Privacy Act of 1974
- Facilitated clinical trials research compliance initiatives throughout JHU - related entities
- Provided education and training opportunities for investigators, clinical coordinators and other research-related staff concerning clinical trial research and regulatory requirements and JHM-IRB policies
- Regularly reviewed and monitored clinical trial research activity by JHM employees and/or JHM agents to assess compliance and to identify potential noncompliance
- Developed and maintained processes for JHM Study Coordinators and PIs to report instances of possible noncompliance
- Develop processes for formulating and recommending corrective action plans to address any instances of noncompliance with JHM clinical trial research-related policies and with Federal and State laws and regulations related to research
- Assessed all research-related documents, financial records, contracts and other information necessary to ensure compliance with regulatory requirements pertaining to research conducted at JHU - related entities
- Developed reports for The Dean of Medicine and Institutional Review Boards
- Collected detailed notes on investigations and other communication to adhere to legal requirements and enhance recordkeeping
- Maintained and updated databases and produced reports outlining results of investigations
- Confirmed data and licensing information through investigations and notified violators of required changes to bring operations into compliance
- Perform investigative site file reconciliation of regulatory binders, eTMF, and query resolution
Research Subjects Specialist
The Johns Hopkins University School Of Medicine
01.2011 - 09.2011
- Determined review process for documents submitted for IRB review.
- Advised and assisted investigators and their staff regarding JHM IRB application submission and review requirements.
- Certified human subject's activities in grant application.
- Formulated agenda materials and tracks components of protocol the review process, including communication with other offices and committees.
- Attended IRB meetings to take minutes as needed.
- Maintained working knowledge of internal JHM IRB procedures.
Clinical Research Coordinator
The Johns Hopkins University School Of Medicine
01.2007 - 12.2010
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Gathered, processed and shipped lab specimens.
- Created SOP for Study Conduct and Good Clinical Practice.
- Responsible for scheduling visits, data collection, electronic and paper record maintenance, regulatory documents, and adverse events.
- Coordinated daily research activities associated with multi-centered clinical trials.
- Implemented policies, coordinate flow of communication between JHU clinic and protocol sponsors.
- Prepared protocol submissions and study-related correspondence to Institutional Review Board.
Education
Masters of Science - Health Administration Informatics
University of Maryland University College
Adelphi, MD05.2015
Graduate Certificate - Informatics
University of Maryland University College
Adelphi, MD05.2015
Bachelors of Science - Business Administration
Stevenson University (Villa Julie College)
Stevenson, MD05.2006
Skills
- Compliance with federal and state laws
- FDA Inspections
- FDA IND Submissions
- Documentation and reporting skills
- Experience in compliance auditing
- Data verification
- Fraud investigation
- HIPAA regulations
- Informed consent processes
- Good Clinical Practices
- Clinical Trial Management
- Clinical study protocols
- Research SOPs Understanding
- Internal auditing
- Compliance oversight
- Information gathering
Affiliations
The Association of Clinical Research Professionals - ACRP Certified Professional
Certification
ACRP-CP
Timeline
Compliance Specialist - Research Quality Assurance
Pennsylvania State University - College of Medicine
07.2016 - Current
CCRA Post Approval Compliance Monitor
Clinical RM (WRAIR)
11.2015 - 03.2016
Compliance Monitoring Specialist/JHM Office of Human Subjects
The Johns Hopkins University School Of Medicine
09.2011 - 11.2015
Research Subjects Specialist
The Johns Hopkins University School Of Medicine
01.2011 - 09.2011
Clinical Research Coordinator
The Johns Hopkins University School Of Medicine
01.2007 - 12.2010
Graduate Certificate - Informatics
University of Maryland University College
Bachelors of Science - Business Administration
Stevenson University (Villa Julie College)
Masters of Science - Health Administration Informatics
University of Maryland University College
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