1. 1KRISTI J. LATORRE, BSN, MBA
5984 Cherryview Lane kristilatorre@gmail.com
Bethel Park, PA 15102 (724)328-3366
Employment History
PPD, Remote based-Pittsburgh, PA- Nov. 2015- Present
Clinical Team Manager:
• Manage the execution of project deliverables within contractual timelines and client
expectations through all active phases (start-up, recruitment; maintenance; closeout-
database lock) of a trial
• Currently Responsible for re-structuring all processes involved in the early clinical phase
department.
• Manage clinical resources (CRAs/administrative team) according to projections of ongoing
clinical activities to ensure maximum resources are allocated to maintain forward
movement of clinical deliverables
• Manage clinical budget; escalate out-of-scope activities to the appropriate individuals for
inclusion in a contract modification
• Track, review, and distribute metric updates (regulatory, enrollment, CRF retrieval, subject
visits, query, etc.) to external/internal clients/vendors
• Manage contingency planning for data cleaning; clinical data listings review; and,
coordinate process for reviewing data listings by clinical team
• Prepare monitoring plan, as well as responsible for the implementation and training of
standardized clinical monitoring processes within the study team
• Oversee the development of source documents, CRF/eCRF guidelines and other project-
specific forms to be utilized during the study period
• Participate in site recruitment and budget negotiations
• Perform secondary clinical review of case report forms for the purposes of discovery of
query trends and CRA re-education
• Provide leadership, coordination, and management of the PPD-customer joint project team
through start-up, conduct, tracking, quality, and regulatory compliance management and
close-out activities
• Perform review of pass-thru travel costs to ensure the most cost-effective travel practices
are being utilized by monitoring staff
• Perform review of trip reports of team CRAs to ensure monitoring activities are
appropriately conducted and documented for the client according the contractual
obligations
• Review essential regulatory documents prior to transmittal to the client for release of initial
investigational product
• May present at Investigator Meetings
2. Covance Clinical Development Services, Princeton, NJ, USA – Apr. 2012 – Nov.15
Senior Clinical Research Associate – Mar. 2013 – Present
• Responsible for all aspects of study site monitoring including routine monitoring and
close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation
visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities:
o Ensure the study staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that informed consent
procedures and protocol requirements are adhered to according to the
applicable regulatory requirements
o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or
other data collection tools by careful source document review
o Monitor data for missing or implausible data
o Ensure the resources of the Sponsor and Covance are spent wisely by
performing the required monitoring tasks in an efficient manner, according to
SOPs and established guidelines, including managing travel expenses in an
economical fashion according to Covance travel policy
• Prepare accurate and timely trip reports
• Manage small projects under direction of a Project Manager/Director as assigned
• Serve as lead monitor for a protocol or project, and may assist in establishing
monitoring plans and trip report review as assigned
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator Meetings
• Participate in the development of protocols and Case Report Forms as assigned
• Participate in writing clinical trial reports as assigned
• Interact with internal work groups to evaluate needs, resources and timelines
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Conduct, report and follow-up on Quality Control Visits (CQC) when requested
3. • Recruitment of potential investigators, preparation of EC submissions, notifications to
regulatory authorities, translation of study-related documentation, organization of meetings
and other tasks as instructed by supervisor as assigned
• Negotiate study budgets with potential investigators and assist the Covance legal
department with statements of agreements as assigned
• Complete process of Serious Adverse Event (SAE) reporting, process production of
reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against
established data review guidelines on Covance or client data management systems as
assigned by management
• Assist with training, mentoring and development of new employees, e.g. co-monitoring
• Co-ordinate designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management
Clinical Research Associate – Apr. 2012 – Mar. 2013
• Was responsible for all aspects of study site monitoring including routine monitoring
and close-out of clinical sites, maintenance of study files, conduct of pre-study and
initiation visits; liaise with vendors; and other duties, as assigned
• Was responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities
o Ensured the study staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study
o Ensured the protection of study patients by verifying that informed consent
procedures and protocol requirements are adhered to according to the
applicable regulatory requirements
o Ensured the integrity of the data submitted on Case Report Forms (CRFs) or
other data collection tools by careful source document review
o Monitored data for missing or implausible data
o Ensured the resources of the Sponsor and Covance are spent wisely by
performing the required monitoring tasks in an efficient manner, according to
SOPs and established guidelines, including managing travel expenses in an
economical fashion according to Covance travel policy
4. • Prepared accurate and timely trip reports
• Was responsible for all aspects of registry management as prescribed in the project
plans
• Undertook feasibility work when requested
• Recruited potential investigators, preparation of EC submissions, notifications to
regulatory authorities, translation of study-related documentation, organization of meetings
and other tasks as instructed by supervisor
• Negotiated study budgets with potential investigators and assisted the Covance legal
department with statements of agreements as assigned
• Completed Serious Adverse Event (SAE) reporting, process production of reports,
narratives and follow up of SAEs
• Independently performed CRF review; query generation and resolution against
established data review guidelines on Covance or client data management systems as
assigned by management
• Assisted with training, mentoring, and development of new employees, e.g. co-
monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as assigned
• Performed other duties as assigned by management
Precision Therapeutics, Pittsburgh, PA, USA - Jul. 2010 – Apr. 2012
Clinical Research Associate – Jul. 2010 – Apr. 2012
• Functioned as administrator, coordinator, consultant, and educator in the management
of oncology specific clinical trials
• Ensured each site has the required staff training and materials specific to industry
standards
• Managed regulatory authority applications and approvals which oversee research of
drug response marker devices
• Acted as a Liaison with doctors and other medical disciplines on all aspects of
conducting trails
• Verified that data is consistent with patient clinical notes and/or source document
verification (SDV)
• Wrote comprehensive visit reports
5. • Cultivate skills in the administration and progress of oncology clinical trials while
understanding the ethical and legal ramifications (for all participants) covering protocol
development, data collection, analysis, monitoring, recording, auditing, ethics &
regulations, liabilities, and responsibilities of conducting research with human subjects
• Position required consummate communication skills, the importance of good clinical
practice (GCP), attention to detail, ability to build effective relationships with trial center
staff and colleagues, and a facility for motivating medical staffs
MedPace, Cincinnati, OH, USA - Aug. 2008 – Feb. 2010
Clinical Research Associate – Aug. 2008 – Feb. 2010
• Functioned as administrator, coordinator, consultant, and educator in the management
of clinical trials
• Assessed the suitability of facilities at study centers
• Ensured each site held the required staff training and materials specific to industry
standards
• Liaised with doctors and other medical disciplines on all aspects of conducting trails
• Verified that data was consistent with patient clinical notes and/or source document
verification (SDV)
• Wrote comprehensive visit reports
• Accounted for all unused trail supplies
• Closed study centers upon completion of trials
• Cultivated skills in the administration and progress of a clinical trial while
understanding the ethical and legal ramifications (for all participants) covering protocol
development, data collection, analysis, monitoring, recording, auditing, ethics &
regulations, liabilities, and responsibilities of conducting research with human subjects
• Position required consummate communication skills, importance of Good Clinical
Practice (GCP), attention to detail, ability to build effective relationships with trial center
staff and colleagues, and a facility for motivating medical staffs
6. Cornerstone BioPharma, Pittsburgh, PA, (Headquarters Cary, NC) USA – Sep. 2007 - May
2008
Pharmaceutical Sales Representative – Sep. 2007 – May 2008
• Established new territory (from ground up) for the sales/marketing of respiratory drugs
(Spectracef, Allerx and Deconsal) throughout Pittsburgh-South and parts of West Virginia
• Administered presentations to physicians encompassing clinical education/product
knowledge/scientific research on aforementioned medications
• Coordinated dinner/lunches throughout assigned territories
• Sold to pulmonologists, ENT specialists, allergy specialists, internal medicine, family
practice, pediatricians, and emergency clinics – to name a few
• Served as intermediary between company and customers
• Promoted products to more than 200 physicians within a 3-month period
• Tripled sales base within a 6-month period
• Targeted accounts based on highest potential value to the company and conducted
personal follow-up to ensure ongoing positive client relations
• Planned and implemented account development activities with focus on achieving sales
plan objectives
• Position required powerful presentation skills, account management, territory planning/
profiling, and persuasion skills for maximizing customer relationships
• Cultivated excellent interpersonal/communication skills in dealing with multiple
medical disciplines
Magee Hospital, Pittsburgh, PA, USA – May. 2006 – May. 2007
Orthopaedic Nurse – May 2006 – May 2007
• Worked with one of Pittsburgh’s foremost orthopedic surgeon in providing proficient,
age specific, professional skills in assessing, planning, implementing, and defining of
procedures up to 8 assigned patients in accordance with legal, hospital practice, and
departmental policies & procedures
• Managed the care of patients before and after surgery involving the muscular skeletal
system such as total hip replacement, arthroscopy, or total knee replacement
• Monitored traction, splint/cast care, and orthopedic equipment
• Interfaced extensively with patients, families, multi healthcare disciplines, and
administrators
7. • Provided patient/family education regarding post-op treatments and procedures
• Specific clinical duties included: medication administrations, IV therapy,
orthovac/hemovac autotransfusions/reinfusions, blood draws, hip/knee dressing changes,
positioning patients in CPM (continuous passive motion) machines, ongoing patient
assessments/evaluations, and charting
Duquesne University, Pittsburgh, PA, USA – 2002 - 2006
Job Coach – 2002 - 2006
• Taught a group of 10 mentally-challenged young adults with downs/autism/learning
disabilities
• Provided instruction and monitored various job functions performed throughout the
Duquesne University campus
• Evaluated assigned caseload on a daily basis reporting progress and/or decline of
assigned staff
Sala Chiropractic, Bethel Park, PA, USA - 2000 - 2002
Chiropractic Assistant Front Desk Operations – 2000 - 2002
• Participated in numerous public relations events with focus on new client recruitment
resulting in a significant increase of new patients
• Communicated with clients of all ages – infants to age 95
• Scheduled patients and maintained records via ChiroPlus Office Software
• Filed patient charts; responded to incoming telephone inquiries; checked patients in/out
of office; initiated appointment confirmation calls; introduced prospective clients to the
facility; completed NCRs and proscribes; labeled x-ray files; read and interpreted patient
charts for rehabilitation treatments; procured necessary insurance information
• Administered heat treatments, electric stimulation, ice treatments and professional
massages
• Adjusted rehabilitation equipment as per clients’ physical needs
• Set up mechanical traction beds
• Maintained stringent sanitation of the facility
Therapeutic Experience
• Cardiovascular: Congestive Heart Failure/Cardiac Edema/Cardiomyopathy,
Hypertension- systolic or diastolic, Hypotension
8. • Endocrine: Diabetes Mellitus / Hypoglycemia / Hyperglycemia
• Infectious Disease: Sepsis- Systemic Infections/Septic Shock
• Oncology: Breast, Colorectal, Lung - Non small cell , Ovarian, Uterine, Cervical,
Devices for Oncology, Lab Test-Assay Test
Language Capabilities
• English
Education
• B.S. Nursing, Duquesne University, Pittsburgh, PA, USA
• M.B.A. Master’s in Business Administration, Pittsburgh, PA, USA
Memberships/Awards
• Inducted into Phi Eta Sigma National Honor Society
• National Collegiate Nursing Award Nominee (United States Achievement Academy)
Other
• Computer Skills: MS Word – Excel – e-Clinical – PowerPoint – WordPerfect –
ChiroPlus