Experienced research professional with extensive experience in managing both clinical and social behavioral health studies in academic and medical settings. Posses strong study oversight and implementation skills along with extensive knowledge of research regulatory processes. Specialty areas include HIV, women\'s health, at-risk youth.
Knowledge of HIPAA regulations
Proficient use of Microsoft Office Suite, Atlas.ti
Excellent organizational skills
Understanding of diverse communities
Research Program Manager, 01/2009 to 01/2012 Columbia University Mailman School of Public Health ICAP – New York, NY
Managed an NIH funded HIV prevention study conducted to examine the feasibility of implementing community based studies among women at risk for HIV infection.
Led day-to-day research process of consenting, recruitment and enrollment of 300 study participants.
Created project documents according to the protocol, including source documentation forms and guidelines, standard operating procedures (SOPs), HIPPA and case report forms (CRFs).
Prepared, facilitated and coordinated the IRB process for accurate and timely submission of documents required for protocol revisions and amendments.
Hired, supervised and trained research assistants and delegated tasks to meet goals and timelines.
Clinical Trail Associate Contractor, 01/2007 to 01/2009 Pfizer, Inc – New York, NY
Ensured regulatory compliance of Trial Master File (TMF) components for clinical research studies.
Participated in inspection readiness/audit for the Trial Master File remediation in response to a major inspection finding.
Tracked studies for accrual, reviewed regulatory documents and reported adverse events, reviewed data clarification requests and amended clinical study agreements and budgets.
Prepared weekly and monthly study status updates and reports.
Manage clinical, regulatory and study-related documents from study start-up through study close-out.
Evaluated and documented data in Viagra studies.
Research Project Manager, 01/2006 to 01/2007 Mount Sinai School of Medicine Center for Cancer Prevention – New York, NY
Supervised and trained research assistants on study measures and procedures.
Monitored adherence to IRB guidelines, prepared and submitted protocol and consent form changes to the IRB and the Department of Defense Army funding contract.
Managed study recruitment and enrollment process, collaborated with site co-investigators to ensure patient eligibility.
Facilitated effective communication between six study sites and project team.
Generated reports and created queries to monitor study data quality.
Research Analyst, 01/2005 to 01/2006 Institutional Review Board Mount Sinai School of Medicine – New York, NY
Performs regulatory analysis and administrative review of IRB submissions to ensure compliance with Federal research regulations and institutional policies (including new submissions, renewals, amendments, AEs and deviations).
Consulted with and provided guidance to study investigators on human subject research protections, adherence to federal and IRB regulations, ethics, and protocol submission requirements.
Assisted with the administrative support of convened IRB meetings.
Bachelor of Arts: Social Psychology and Education, University of Massachusetts - Boston, MA