Yvonne R. Gorham, CIM, CCRP, CSSGB
**** – 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: email@example.com 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: firstname.lastname@example.org 3
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
Experience managing Clinical Trials, working with a number of sponsors and Clinical Research Organizations
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
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