Kimberly Turner

• Provide oversight to CRA site management activities
• Develop and conduct departmental training
• CTMS Super User
• Supervise and assist with clinical study teams resourcing, CRA assignments and allocation of resources
• Interviewing, hiring and termination of CRAs
• Development of CRA training materials
• New-hire onboarding
• Monitor CRAs performance including study metrics and KPIs
• CRA 1:1 Meetings
• CRA Team Meetings
• CRA Career Development
• Annual/Bi-Annual CRA Performance Review
• Change Initiatives for Process Improvement
• Communication with clinical teams, sponsors, leadership teams, and stakeholders
• CRA Oversight Visits
• Manage of site trends
• Conduct, attend, or support co-monitoring visits
• Development and revision Of study plans, resources and monitoring tools
• Quality Oversight
• Deviation Management
• Regulatory Oversight
• Safety Management
• Site Management/CRA Oversight
• Risk Mitigation
• Budget projections and forecasting of study resources needs
• Team communication and collaboration

• Provided site management and monitoring services and other sites and study activities to ensure adherence to GCP/ICH., GLPs, regulatory requirements, protocol compliance, and safeguarding patient rights and safety
• Submission of trip reports and site follow-up letters meeting set timelines as per the clinical monitoring plan
• Verification of ICF process, study participant eligibility, continued eligibility, review of all source, and data entry ensuring protocol compliance, and patient safety
• Reviewed, collected/uploaded (to eTMF) and tracked all site IRB/IEC submissions and approvals not limited to protocol/amendments and ICF documents, annual reviews, 1572s, Financial Disclosure Agreements, CVs, MLs, GCP/ICH training, study training, etc.
• Specimen and IP management
• Enhanced communication among team members to foster collaborative and supportive work environment

• Anticipation of obstacles and proactively defining solutions needed to achieve successful project outcomes, adherence to project budget, scope, and timelines ensuring project deliverables were met
• Ensure compliance of CRA training for study specific systems and study documents
• Initiate and develop internal document housing structure within the BOX, a cloud-based document management system
• Development of study resources and assessment tools
• Lead Sponsor team calls with partner collaboration as well as conducting routine bi-weekly CRA meetings
• Conducted weekly Investigator calls to discuss subjects safety and scan results, protocol amendments, and slot availability as well as providing regular site updates to required 30-45 day data cuts for DSMB meetings and subsequent dose escalation
• Maintained and managed IP Tracking and Enrollment system (Suvoda) ensuring timely and accurate updates made for consent dates, IP assignment, dosing data, IP accountability, and required dosages are entered for newly opened cohorts in dose escalation and additional IP entered for dose expansion
• Track and report CRA project metrics with CRA line managements and operations team
• Review and approval of CRA Expense Reports and Timesheets
• Site set-up and tracking of study milestones in CTMS system (Veeva Vault)
• Organized and detail-oriented with a strong work ethic
• Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members

• Develop strong site relationships
• Perform clinical study site management/monitoring activities
• Protocol Expert
• Site feasibility and selection
• Essential document collection/validation and site activation
• Perform remote and on-site monitoring and oversight activities for all visit types
• Data Management review and oversight of assigned sites
• Protect patients' rights, safety, and well-being
• Documentation of all non-visit site
• eTMF document collections and filing
• Communicate with Investigators and site study staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identify, assess, and resolve site performance, quality or compliance concerns and escalate per defined CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head and CRD as applicable
• Work in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and development of study tools
• Support and/or lead internal site audits
• Mentor junior CRAs
• Responsibly managed up to 12 clinical protocols targeting solid tumors in Lung, Head/Neck, Gastrointestinal, and RCC for efficacy and safety of Pembroluzimab, now known as Keytruda

• Served as a liaison between Mirati Clinical Operations group, investigators, KOLs and study coordinators for three (3) Mirati clinical trials to ensure optimal conduct, support, training, process implementation, and enrollment
• Engage, foster, and nurture relationships with investigators and research staff through quarterly on-site meetings, recurrent training, and other specific collaborations with continuous interactions to support patient recruitment and enrollment activities
• Cultivated and maintained robust relationships with investigators and site research personnel
• Engaged in collaborative communication with the Mirati clinical operations team to assist site investigators in addressing risks and challenges affecting patient recruitment, enrollment, and retention
• Developed and monitored enrollment modeling scenarios and data analytics to consistently assess recruitment forecasts
• Provided training for investigators and site research staff aimed at effectively identifying and reporting system-related issues to optimize the utilization of site resources for successful study recruitment
• Development and presentation of comprehensive study information tailored to the needs of investigators, and site research teams
• Served as site educational resource
• Summarization of field interactions to operational leadership teams via status updates, visit summaries, and outcome metrics aligned with project objectives
• Proactive in advancing personal knowledge of disease states and evolving treatment trends that might influence Miratis' clinical trial initiatives.
• CRO Oversight
•Vendor Oversight

• Worked as an independent consultant in various roles:
- SR CRA, Kythera BioPharmaceuticals
- Clinical Line Manager, PRA
- SR CRA, Celerion Healthy Subject Phase 1 Unit
- SR CRA, Alta Sciences Healthy Subject Phase I Unit
- SR CRA, Vince and Associates Healthy Subject Phase I Unit
- SR CRA, Lotus Clinical Research
- SR CRA, PSI
- Lead CRA, KPS Life Sciences
- SR CRA, Covance
- Clinical Site Engagement Liaison, UCB
- SR CRA, Amgen

• Optimized resource allocation by strategically prioritizing tasks according to project timelines and client expectations.
• Maintained up-to-date knowledge of relevant technologies and best practices through ongoing professional development efforts.
• Managed multiple simultaneous projects, consistently meeting deadlines without compromising patient safety. quality or accuracy.

• Managed up to 35 Consultant CRAs
• Conduct interviews and provide recommendations for prospective new consultants (CRAs) for ICON clinical trial programs
• Oversee training during the onboarding process for new hires and ensure the continuous professional development of staff
• Regularly evaluate performance against established goals and objectives through collaborative team feedback
• Conduct routine consultant 1:1 calls
• Conduct routine client calls
• Conduct consultant performance evaluations
• Review, negotiate and execute consultant contracts and contract renewals
• Oversight for necessary disciplinary actions and/or improvement plans for consultants
• Ensure that services are delivered to clients in accordance with contractual agreements, including adherence to study goals, metrics, scope, and budget
• Review and authorize all timesheets and expense reports submitted by consusultants
• Support clients in identifying their resource needs effectively
• Facilitate the resolution of issues between clients and DOCS consultants
• Led the development of operational initiatives and change processes
• Led the implementation of a new time and expense system for DOCs consultants, which streamlined payroll and reimbursement processes while maintaining high standards of customer service to the client

• Conduct all types of monitoring visits
• Provide continuous training and guidance to site research staff regarding study protocols, systems and trial procedures
• Electronic Data Capture (EDC), eTMF and CTMS
• Risk review and implement mitigation strategies
• Work collaboratively with the Project / Data Management teams
• Adherence to all KPIs, SOPs and Study Metrics
• Foster motivation and build strong relationships with site investigators and research staff to support the sponsor's goal of becoming their preferred clinical research partner
• Collaborate with vendors while overseeing the delivery of their commitments.
• Aid the site in organizing and archiving trial documentation within the Investigator Site File
• Attend investigator meetings and engage with site research staff to cultivate positive relationships
• Diligent oversight for GCP/ICH and regulatory compliance at all times
• Provided support during internal audits and FDA inspections (as requested)
• IP and Specimen Management
• Conducted root cause analyses to identify, identify and resolve trends / recurring issues at the sites

• Conduct PSSV, SIV, IMV, and COV to completion of the trial in both the US and Canada
• Verify data entered to the eCRFs are consistent with patient clinical notes/source
• Ensure regulatory compliance
• Document site visit reports adhering to designated timelines for finalization
• File and collate trial documents and reports
• Creation of TMF (paper)
• Ensure all used/unused trial supplies and investigational product/devices are accounted for
• Creation and implementation of study documents and site resources
• Conduct global bi-weekly team calls
• Drafting quarterly clinical trial newsletters
• Assignment of CRA sites, maintaining CRA metrics as per KPIs, visit report review for the purpose of training, conduct annual/biannual training for quality, monthly documentation of CRA performance for CRA annual merit increase
• Hold 1:1 calls with CRAs for career path progression, performance, and oversight
• Participate in weekly leadership calls
• Maintenance and monitoring of two (2) sites as a SR CRA to ensure quality and keep up to date on real-time study activities to better lead the CRA team
• IRB submissions and tracking, tracking of safety issues, protocol deviations, action items, queries, SDV activity, FAQs, and DICOM disc submissions, etc.

• Ensure that on-site personnel possess the necessary materials and training to conduct the study safely
• Safeguard study participants by thoroughly verifying that informed consent procedures and eligibility criteria in accordance with study procedures per protocol and GCP/ICH guidelines
• Assurance of patient safety and data integrity through 100% Source Data Verification and review/validation of electronic case report form (eCRF)
• Review source documentation and reporting for all SAEs in compliance with ICH/GCP, protocol requirements and Institutional Review Board (IRB) regulations
• Accountability for investigational products to ensure patient dosing for safety and proper documentation of receipt and dispensation of inventory is maintained
• Regularly review and reconciliation of investigator site files and trial master files to guarantee proper maintenance
• Utilization of resources judiciously, including corporate credit cards, by executing tasks and travel in a cost-effective manner
• Preparation and submissions of monitoring visit reports along with time and expense documentation as per the SOPs and study requirements
• Create resource tools and documents to facilitate site management and clinical study execution
• Assess the qualifications of investigators and sites to provide informed recommendations regarding their potential involvement in clinical studies
• Monitor daily progress of clinical site activities and consistently update relevant clinical status trackers
• Proven success working within tight deadlines and in a fast-paced environment
• Strengthened communication skills through regular interactions with others
• Demonstrated strong organizational and time management skills while managing multiple projects

• Lead for all US Oncology locations across two protocols
• Provided direct supervision to contracted Clinical Research Associates (CRAs) assigned to the projects
• Conducted interviews with contract CRAs employing the STAR interview technique
• Mentored and trained newly recruited Lilly contract CRA
• Reviewed and authorized investigator study visit reports
• Designed and distributed monitoring tools tailored for specific studies
• Developed specialized tracking tools for data analysis related to the studies
• Co-monitored alongside new contract CRAs to ensure adherence to quality standards
• Managed study-specific vendor relationships effectively
• Led weekly teleconferences with the study team for progress updates and discussions
• Oversaw audit processes of clinical sites conducted by the CRA team
• Assisted in drafting notification letters to the FDA regarding potential concerns at clinical sites
• Executed all types of site visits, from feasibility assessments to close-out meetings, documenting actions taken and following up on action plans accordingly
• Completed the Eli Lilly CRA Foundations

• Provide support to project PM and field based CRA team
• Maintain regulatory documentation in TMF for assigned sites
• Possess a solid understanding of the protocols and requirements pertinent to assigned projects
• Receive and evaluate data collection (paper CRFs) for thoroughness and clarity, as well as to identify any potential unreported Serious Adverse Events (SAEs)
• Ensure adherence to critical timelines within the study's trajectory
• Promptly notify the safety team upon identification of any unreported SAEs
• Monitor participant enrollment status, manage inventory of drug/study supplies, and facilitate re-supply processes
• Engage daily with the IVR systems utilized for tracking enrollment, drug supplies, and generating ad hoc reports as necessary for the team
• Collaborate regularly with IVR vendors to implement corrective measures within the IVR system when required
• Provide assistance in addressing clinical and supply chain challenges
• Participate in teleconferences, meetings, and investigator gatherings as needed by the study team
• Duplicate regulatory files for closeout visits to guarantee comprehensive onsite reconciliation conducted by field Clinical Research Associates (CRAs)
• Reach out to prospective investigator sites following the project-specific feasibility process to assess their interest

• Primary coordinator for asthma, allergy, and immunology trials in both adult and pediatric populations
• Worked closely with the investigator in the identification of patients, obtaining consent / assent / reconsent, performing screening procedures to determine eligibility, and enrollment/randomization of patients
• Safeguard patient private health information in compliance with HIPAA regulations
• Preparation and administration of investigational medications
• Manage inventory of investigational product, provided study equipment, lab kits, and necessary ancillary study supplies
• Attend investigator meetings
• Ensure compliance with ICH/GCPs, GLPs, IRB regulations / requirements and OSHA standards
• Submit initial and annual study reviews
• Comply with facility SOPs and training requirements
• Completion of all study required training and gain access to IVRS, EDC, and any applicable share platforms designated by sponsor
• Scheduling of all CRA visits, correct / resolve any issues noted, routinely review and resolve action items, open queries and/or missing pages during the study as well as title response during interim analysis or database lock events
• Ensure investigators timely review and assessment of lab results or other patient testing required by the protocol
• Maintenance of the ISF
• SAEs, submission to IRB and notification to Sponsor within required timelines and follow to resolution
• Coordinate multiple studies concurrently while maintaining all associated responsibilities and activities as required
• meet with investigators weekly to provide study status updates
• Organize and conducted regular staff meetings for improved collaboration and enhanced patient care and client satisfaction
• Managed subject recruitment efforts (advertising) resulting in a diverse participant pool.
• Collected, processed, and shipped lab specimens
• Maintain all routine study logs as required

• Facilitate the organization of clinical trials focused on oral cardiac medications and cardiac implant devices for both inpatient and outpatient participants
• Educate patients and family members on at home dosing administration and diary completion
• Possess a thorough understanding of Federal CDRH Guidelines
• Oversee the proper preparation, administration of study medications in clinic
• Safeguard patient private health information in compliance with HIPAA
• Transpose patient source data to the Paper Case Report Form (CRF) or electronic Case Report Form (eCRF) accurately add completely following CCG guideance
• Attend bi-monthly cardiac board meetings with MAC and KUMC cardiac physicians to discuss new trails and provide status updates for ongoing studies
• Regulatory submissions for local IRB for approvals and bi-annual updates
• Conduct both in-patient and out-patient visits with cardiac implant devices
• Proven ability to learn quickly and adapt to new situations
• Skilled at working independently and collaboratively in a team environment
• Assisted with day-to-day clinical operations, working collaboratively with all research team and ancillary staff

• Mentored junior technicians in best practices for proper collection and processing of specimen/blood
• Participated in lab meetings and project presentations
• Managed inventory of laboratory supplies
• Conducted routine testing equipment quality control checks to ensure accurate test results
• Followed all HIPAA, OSHA and GLPs standards
• Collected and processed blood, urine, fecal and sputum specimens from hospitalized patients
• Utilization of PPE

• Sanitized, restocked, and organized hospital rooms and medical equipment supplies
• Obtained client medical history, medication information, symptoms, and allergies
• Performed medical records management, including filing, organizing and scanning documents
• Built strong relationships with patients through effective communication skills that foster trust in the hospitals commitment to quality care
• Maintained a safe and clean clinical environment by adhering to infection control guidelines and disposing of biohazardous waste properly
• Ensured patient safety and comfort during examinations and testings, effectively addressing concerns and answering questions
• Boosted patient and their families satisfaction by providing compassionate and empathetic care
• Performed phlebotomy tasks efficiently while ensuring minimal discomfort for patients during blood collection procedures
• Contributed to positive health outcomes by educating patients on preventative measures, treatment plans, and follow-up care instructions
• Ensuring accurate diagnoses by performing laboratory tests and preparing specimens for analysis properly
• Provided support during code blue events by administering first aid treatments under nursing supervision until further assistance arrived
• Performed and charted vitals
• Performed EKGs
• Provided excellent patient care to long-term patients on the transplant unit

• Sanitized, restocked, and organized exam rooms and medical equipment supplies
• Obtained client medical history, medication information, symptoms, and allergies
• Directed patients to exam rooms, fielded questions, and performed assessments and a collected standard labs for physician examinations
• Performed medical records management, including filing, organizing and scanning documents
• Built strong relationships with patients through effective communication skills that foster trust in the clinic''s commitment to quality care
• Collection of blood and manual testing for PT/PTT-INR in-house for doctor review
• Collection of blood and testing of CBC w/differential in-house on the J T2 Coulter for doctor review
• Collection and processing of all chem 12 panels in-house for doctor review
• Maintained CAP/CLIA verifications for the in-house lab
• Track and order all in-house medications and blood testing equipment reagents for in-house lab testing
• Provide doctor assistance during patient examinations
• Review lab results denoting any outside normal range values for doctor review
• Communicated test results to patients and subsequent follow-up actions as ordered by the doctor
• instruct patients on heparin/warfarin dose decrease and escalations and signs/symptoms they would need to call the doctor
• Phone in patient prescriptions and refills to pharmacy
• Preparation of patient medication for in-clinic dosing
• Preparation and administration of patient injections (Filgrastim, Epoetin, annual vaccines, etc.)
• Schedule patient diagnostic, surgical and follow-up procedures
• Created and maintained patient charts
• Weekly meeting with doctor to discuss the next weeks schedule, procedures and any adhoc tasks for completion