Professional

Yvonne R. Gorham, CIM, CCRP, CSSGB

**** *** ****** ******, ****** Beach, FL Phone: 813-***-**** Email: *********@*****.*** 1

Professional Experience:

**** – 2019 Project Manager, Regulatory Affairs Tampa, FL H. Lee Moffitt Cancer Center and Research Institute

Supervised regulatory specialists on the startup team, held weekly meetings to review trials in the program and maintain open communication

Direct liaison for Sponsors, Institutional Review Boards (IRBs), and clinical staff.

Established and maintained excellent working relationships within internal and external customers.

Created and maintained departments Standard Operating Procedures (SOPs).

Team-player; always provided operational support to the team in workload and meeting deadlines

Maintained required documents (Curriculum Vitae (CV) for all Physicians and medical license, Good Clinical Practice (GCP) and Human Subject Protection (HSP) were up to date).

Responsible for clinical research projects through the study start-up (90 day activation goal).

Followed all Institutional Standards and Procedures/ Policies.

Worked directly with the IND office to ensure documents were prepared and ready for FDA submission

Presented data to executive leadership and external customers (Sponsors/Clinical Research Organization (CROs)

Managed all components of clinical trials from start up to activation; submission of the study to Scientific Review Committee (SRC); IRBs; electronically filing and obtaining all required regulatory documents (FDA 1572, Financial Disclosure Forms (FDF), etc.

Created Informed Consent Forms (ICFs) for subjects to agree to participate in a clinical trial.

Functioned with Principal Investigators and Clinical Trial Managers across multiple programs to review studies and ensure all required documents were ready for trial review.

Interaction with both local and central IRBs to review applications and address any queries

Implemented new eBinder system throughout Institution (Florence eBinder suite).

Implemented new Biosafety Review with Advarra Institutional Biosafety Committee (IBC).

Submitted studies through all required boards (SRC, IRB, IBC and Department of Defense (DOD)). 2011 – 2015 PRMS, Scientific Review Coordinator, Protocol Review Office Tampa, FL H. Lee Moffitt Cancer Center and Research Institute

Supported and coordinated the Scientific Review Committee (SRC); Data Monitoring Committee (DMC) and Protocol Monitoring Committee (PMC).

Provided overall support and organization for all the committee’s functions and responsibilities.

Served as the point of contact for all activities related to implementing and monitoring adherence to the DMC

Assisted the investigators in the development of an adequate data and safety monitoring plan for their protocols as well as development of required periodic data and safety reports

Reviewed submitted protocols for accuracy and that they meet the required elements for placement on a committee

Responsible for compiling agendas, assigning committee reviewers, composing official meeting minutes

Tracked responses from investigators from meetings, followed through to ensure all documents were approved.

Conducted quarterly educational classes to educate new Moffitt employees how to submit new submissions and amendments in Moffitt’s ePRMS system (OnCore).

Provided support to clinical trial coordinators, regulatory specialists, directors, and all other Moffitt staff in identifying obstacles, and to develop and enact solutions

Independently verified new research trials are in compliance with the mandated safety monitoring plan prior to submission to the Scientific Review Committee.

Prepared documents in collaboration with the study Principal Investigator, including confidentiality agreements, conflict of interest statements and charters for each study requiring DMC review.

Coordinated travel and meetings arrangements for all meetings as needed.

Lead and educated new staff members in the requirements for data and safety monitoring compliance. Yvonne R. Gorham, CIM, CCRP, CSSGB

6402 Key Island Avenue, Apollo Beach, FL Phone: 813-***-**** Email: *********@*****.*** 2

2010-2011 Clinical Research Department Regulatory Affairs Manager Clearwater, FL Clearwater Cardiovascular & Interventional Consultants

In conjunction with clinical trials coordinators, assisted with EDC entry, prepared and reviewed data and resolved any queries.

Provided clinical input to leadership and clinic physicians.

Worked with sponsors and CRO in Site Initiation Visits (SIV), ongoing study monitoring and study close-out visits at end of study.

Responsible for submitting trials to local IRB for review of human subject protection.

Obtained all regulatory documents (FDA 1572, conflict of interest, financial disclosure forms).

Maintained all regulatory binders and prepped them for upcoming sponsor and FDA audits

Reviewed protocol and ICF documents for administrative review preparatory to Research Steering Committee

(RSC) and Research Council meetings.

Responsible for any RSC agenda items discussed at meetings (i.e., approval letters, feasibility questionnaires or specific investigator requests regarding protocol procedures.

Responsible for negotiating budgets and contracts with sponsors 2005-2010 Clinical Research Coordinator Clearwater, FL Clearwater Cardiovascular & Interventional Consultants

Responsible for screening for potentials clinical trial subjects for ongoing trials

Administered Informed Consent to potential subjects.

Conducted all study visits per protocol requirements.

Completed and reported all SAE and Deviation reports for sponsors and IRB submission.

Responsible for ordering supplies for clinical trials (binders, lab kits, case report forms).

Performed data entry functions among a wide array of Electronic data capture (EDC), such as Inform, Oracle, E-Trials, I-data and Medidata.

Processed labs and shipped to central laboratories per protocol requirements.

Responsible for attending all Site Initiation Visits (SIVs) and study close out visits at end of trials. 2001-2005 Patient Scheduling, Medical Records Clearwater, FL Clearwater Cardiovascular & Interventional Consultants

Responsible for back office duties which included answered all incoming calls from patients

Scheduling appointments for patients

Generated general correspondence and letter templates for office

Kept the department calendar for scheduled patient visits and physicians meetings

Maintained office supplies and other inventory and placed order for supplies

Prepared medical records for patients and other Drs. Offices

Obtained HIPAA authorization and medical release forms from patients

Responsible for keeping patient rooms clean and organized 1998-2001 Research Coordinator, Dept. Regulatory Coordinator Palm Harbor, FL Advanced Gastroenterology Associates

Responsible for recruitment of clinical trial subjects

Administered Informed Consent from subjects to participate in a clinical trial

Obtained regulatory documents (i.e., CVs, Investigator agreements, 1572, lab certificates/values and licenses)

In conjunction with the Principal Investigator reviewed contracts and budgets and assisted in negotiations with the sponsors

Identified obstacles within the department and develop solutions

Responsible for preparing and maintaining study consents and all regulatory documents for auditing purposes

Obtained and processed any lab/ specimens for pharmaceutical studies Yvonne R. Gorham, CIM, CCRP, CSSGB

6402 Key Island Avenue, Apollo Beach, FL Phone: 813-***-**** Email: *********@*****.*** 3

Skills

Excellent communication ability and skills for interacting among internal & external customers

Consistently provides quality products/services

Ability to quickly adapt to changes, communicates and implements change in a positive manner

Demonstrates ability to identify problems and propose effective solutions

Looks for ways to improves processes and increase efficiency

Accepts accountability for actions, outcomes

Projects pride in my work as exhibited in day to day interactions with staff, co-workers, patients and all those whom I come into contact with

Excellent oral and written skills and ability to effectively apply these skills

Strong communicator

Experience managing Clinical Trials, working with a number of sponsors and Clinical Research Organizations

(CROs)

Excellent interpersonal skills and problem solving ability

Working knowledge of ICH guidelines, Human Subject Protection, Good Clinical Practices, HIPAA and applicable regulations, and guidelines related to clinical trials

Excellent organizational skills to maintain multiple tasks and projects

Positive attitude and works well in a team and independently

Proficient in Microsoft office suite

Compassionate and caring

Education:

2016 Associates in Arts Degree / Health Care Administration / Psychology Pasco Hernando State College (PHSC)

2014 Certified Six Sigma Green Belt (CSSGB)

Aveta Business Institute

2012 Certified Clinical Research Professional (CCRP) Society of Clinical Research Professionals (SOCRA) 2009 Certified Institutional Review Board Manager (CIM) National Association of IRB Managers (NAIM) Certification # 2009-19 Memberships:

2009 - 2016 Navy Ombudsman for the SOCOM unit at Mac Dill 2009 - 2011 Vice President - Association of Clinical Research Professionals (ACRP Suncoast Chapter) 2011- 2016 Regional Ombudsman for IDC Region SE- Jacksonville JICCENT 0174 2012 - 2016 President – Association of Clinical Research Professionals (ACRP Suncoast Chapter) 2014 Nominated for the PHCC Student Ambassadors Program 2016 Phi Theta Kappa International Honor Society “Alpha Zeta Epsilon” 2016 Inducted into the Phi Beta Kappa Honor Society in Psychology Professional references provided upon request

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