Teresa Creamer Email & Phone Number

Boehringer-Ingelheim Ridgefield, Ct

• Assist in the operational activities involved in the planning, conduct and completion of IIS and ECR clinical trials. • Use independent action and judgment to complete activities • Preparation, Collection, review and filing of clinical trial documentation• Preparation, facilitation of essential trial meetings (e.g., trial preparation meeting, investigator meeting).• Handle requests for trial related information• Establish target dates for completion of assignments. • Establish and order clinical supplies• Preliminary and post launch testing of external research grants web portal• Track and request grant payments, AE reconciliation, IRB approval, enrollment updates, milestone targets• Communicate with investigative site on routing matters concerning ongoing trials.• Adhere to governmental regulations and company SOPs when executing assignments

Tampa, Fl

• Team lead to manage CSR Investigator and IRB Appendices review• Accurately projected work and resourcing requirements• Escalated issues identified and provided regular status updates to CSR team• Created final Appendices and financial disclosure tables• Performed debarment check of investigators, reviewed site data and regulatory documentation• Managed creation, activation, maintenance of sites in the CTMS from start up to closure• Collaborated with automation team and CRO partner to provide CTMS expertise to automate Cardiovascular Trials• QC’d data to ensure the completeness and accuracy of CRO automated studies• Interacted with CRO teams to receive, complete and archive requests in CRO portals.• Acted as SME for eTMF, CTSS delegate for STM Study Start Up initiative • Interacted with Japan global partners and BMS sponsor to ensure smooth start up for ONO collaboration studies • Trained CTSS colleagues and participated in the revision of ONO collaboration processes• Filed site documentation in eTMF• Requested, approved, identified issues with system access for electronic data capture (EDC), interactive voice response systems (IVRS/IWRS), My Trials, BMS ID for external site staff and team members • Job shadowed with RCA CTA’s including CDA)/Clinical Trial Agreements process and study start up, site facing documentation and processes• Assisted with in-house audit and inspection of study file documentation • Participated in User Acceptance Testing (UAT) testing for roll out of new version of eTMF

Wallingford, Ct

• Performed quality review checks in CTMS on BMS external contacts and accounts before association with site• Flagged and entered information regarding Investigator regulatory compliance issues as a result of Health Authority, FDA inspections, Internal audits and FDA debarment and warning letters• Utilized technology effectively to support project team needs and clinical development processes.• Performed quality review Preliminary FDA Audit work, redacting and watermarking

Niantic, Ct

·• Administrative/project support to Oncology Director of Compliance Oversight and Compliance OS Leads• Supported operational conduct of approximately 125 clinical trials in the oncology portfolio• Managed resourcing spreadsheets, updated protocol and site selection databases and trackers• Scheduled meetings and took detailed meeting minutes on decisions and action items and distributed to team • Collected and collated critical study/site data to generate accurate, timely reporting to Pfizer Leadership team • Utilized analytical skills to determine currency of their data for reporting on study start up times and site enrollment• Maintained oncology team calendar; updated site visits and vacation time for Compliance Oversight Leads• Managed Outlook distribution lists • Coordinated planning of onsite meetings and offsite global meeting including space/site planning, room set up, travel, overnight accommodations, meal planning and AV/IT arrangements• Maintenance of Oncology SharePoint space, granting permissions, posting, organizing and maintaining files • Organized alignment of Compliance Oversight Lead (COL) POCs to oncology networks and key institutions

New London, Ct

• Used system expertise to review and provide suggestions to improve training for CTMS application• Provided system users with support for CTMS application, answered service center support tickets, ensured system users understood training requirements, processes, data management requirements and administrative tasks• Awareness of the federal regulations governing the protection of human subjects (FDA, GCP/ICH guidelines and HIPAA regulations) • Identified and merged duplicate investigator registrations in Registry database.• Interacted with investigator Due Diligence Specialists and WDQA to insure system and regulatory processes regarding investigator availability and confidentiality were upheld• Ran metrics to identify and alert CSDM group leads and CTMS users of SOP non-compliant protocols and centers • Participated in UAT for CTMS system releases• Performed QC of study data and data clean-up projects in Registry database

New London, Ct

• Participated in Pharmacia migration project from QC of migrated data to backfill of protocol and site details• Contacted key personnel and searched DMPS, eTMF, Pisces for missing documents• Reviewed protocol, 1572 and clinical study report documentation• Trained new team members to ensure project met time, quality and cost targets

Bachelor'S Degree, Fine Arts W/Specialization In Graphic Design

Bachelor'S Degree