Kate Ham Email & Phone Number

Holly Springs, Nc, Us

Xcenda/AmerisourceBergenManager, Clinical Research OperationsOctober 2022 to Present Job Description:● Develop and manage study timelines including key milestones.● Prepare study-specific documents including protocols, informed consent forms, newsletters, clinical study reports, monitoring plans, training materials and other required study documents.● Participate in review of CRFs, CRF completion guidelines, data management plans, and statistical analysis plans.● Proactively manage assigned study sites from start-up through close-out to ensure that studies are conducted in compliance with the study protocol, applicable regulations and SOPs and are conducted within specified budgets and timelines.● Identify potential clinical sites and conduct formal feasibility assessments. Prepare reports and make recommendations regarding site selection.● Prepare Clinical Trial Agreements and site budgets.● Conduct qualification, initiation, interim and close out monitoring visits. Monitoring visits are primarily conducted remotely. Task includes follow-up on outstanding action items to resolution and generation of monitoring reports.● Oversee and track subject recruitment and retention. Proactively work with sites and Sponsors to identify recruitment challenges and develop strategies to address challenges to meet recruitment timelines.● Monitor study data to ensure accuracy and integrity. Generate data queries and work with sites to resolve data queries to ensure high quality data with minimal missing data. ● Create and maintain the Trial Master File (TMF); ensure that regulatory documents are acquired, complete, and compliant.● Lead internal and external study meetings that includes the generation of meeting agendas and minutes.● Perform testing for electronic data capture systems.● Coordinate IRB and ethics submissions, amendments and annual updates.● Support the preparation of proposals in response to RFPs received from Sponsors.

Job Description:Responsibilities include independent and proactive coordination of identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed; conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations; and assuring that data is reported accurately and timelines are maintainedThe Sr. SMA also provides a benchmark of remote monitoring and site management experience to less experienced colleagues Acted in a Clinical Trial Manager (CTM) capacity from October 2018 to August 2020; responsibilities included organizing, implementing, and coordinating all monitoring and site management activities within the study team, from study start-up through study close-out, done in accordance with the study protocol, applicable GCP/ICF/GEP Guidelines, applicable regulatory requirements, SOPs, and other documentation requirements Studies:A long-term non-interventional registry to assess the safety and effectiveness of XXXX in patients with moderately to severely active Crohn’s, Ulcerative Colitis (UC) or Indeterminate Colitis (IC)Countries handled (No. of sites): United States (36 sites)Study stages handled: MonitoringTo assess the effect of a new critical pathway compared to usual care for the treatment of ABSSSI during initial care (the date of enrollment to 14 days) and follow-up (30 days after initial care)Countries handled (No. of sites): United States (12 sites)Study stages handled: Monitoring, Close-OutClinical study to evaluate the safety and efficacy of XXXX in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF) Countries handled (No. of sites): United States (5 sites)Study stages handled: Monitoring

Job Description:Responsibilities include independent and proactive coordination of identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed; conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations; and assuring that data is reported accurately and timelines are maintainedThe Sr. SMA also provides a benchmark of remote monitoring and site management experience to less experienced colleagues Acted in a Clinical Trial Manager (CTM) capacity from October 2018 to August 2020; responsibilities included organizing, implementing, and coordinating all monitoring and site management activities within the study team, from study start-up through study close-out, done in accordance with the study protocol, applicable GCP/ICF/GEP Guidelines, applicable regulatory requirements, SOPs, and other documentation requirements Studies:A long-term non-interventional registry to assess the safety and effectiveness of XXXX in patients with moderately to severely active Crohn’s, Ulcerative Colitis (UC) or Indeterminate Colitis (IC)Countries handled (No. of sites): United States (36 sites)Study stages handled: MonitoringTo assess the effect of a new critical pathway compared to usual care for the treatment of ABSSSI during initial care (the date of enrollment to 14 days) and follow-up (30 days after initial care)Countries handled (No. of sites): United States (12 sites)Study stages handled: Monitoring, Close-OutClinical study to evaluate the safety and efficacy of XXXX in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF) Countries handled (No. of sites): United States (5 sites)Study stages handled: Monitoring

• Responsible for screening, recruiting and initiating investigative sites for participation in the study; follow-up with selected investigative sites to ensure smooth progress of the study.• Perform quality control of data collected and data clarification phone calls.• Conduct all study training for new sites/site staff/sponsor staff. Train, mentor and support new SMA’s and new study team members when required. • Assist in the development of departmental and project-specific processes and procedures; most notably creation of a project-wide document for study processes on-site.• Responsible for updating and maintaining study information in the Study Management System, including Registrak and RAVE EDC systems.• Assist with the development of study manuals, training documents, quarterly study newsletters distributed by the sponsor and weekly site contacts.• Liaison for sites with the Copernicus IRB Group or Local IRB for site start up and all Continuing Review activities, protocol deviations/safety reporting, and site closures.• Assist the project team with discussion/negotiation of the clinical trial agreement with investigational sites.• Serve as a Back-Up Clinical Team Lead in the absence of the Clinical Team Lead, ensuring team compliance with study budget, time entry guidelines, related study specific SOP’s and GCPs.

Raleigh, Nc

• Manages the recruitment and qualification of assigned study sites • Independently coordinates and performs site start-up activities, site management, monitoring, and close out of participating sites. • Responsible for scheduling and planning tasks with minimal oversight to meet requirements of the budget, monitoring plan, and SOPs on a daily basis. • Performs or collaborates in the training of sites on study protocol, guidelines, operations, and data submission • Monitors participating sites to ensure quality and integrity of data, site adherence to protocol, applicable GCP/ICH/GEP Guidelines, applicable regulatory requirements, and other documentation requirements. • Ensures adherence to the protocol by review of subject consenting procedures, inclusion and exclusion criteria, randomization procedures and blinding conditions, collection and storage of investigational product (IP), and IP accountability procedures as applicable. • Independently conducts site selection visits, pre-study site visits, study initiation visits, interim site visits, and study closeout visits according to FDA regulations and ICH guidelines, company or customer SOPs, as defined by the monitoring plan • Reviews clinical data for completeness and accuracy, identify discrepancies, and work with field/site personnel to resolve issues and ensure timely collection of data and query resolution• Participates in the development of study-specific forms, tools, and or processes (e.g. questionnaires, case report forms, consent forms, newsletters, reports, etc.) and participate in Investigator Meeting planning in collaboration with the SMC Manager• Acts as primary liaison with participating sites to convey project information and answer questions, troubleshoot, advise, and follow up on study progress with sites• Depending on the nature of the study, may interact directly with study participants

Duke Institute Of Molecular Physiology

*Project manager for one NIH funded research trial pertaining to the use of ultrasound and carotid artery stenosis *Project manager for five funded grants in the fields of vascular health (peripheral arterial disease, diabetes), exercise, oncology and HIV*Coordinate day to day lab activities including scheduling and financial tracking*Doubled lab revenue in three years*Prepare and present study information at local and national meetings including 2009 ACSM*Create and maintain all Institutional Review Board materials for NIH trial and all other grants*Recruit potential patients for five current studies*Perform all ultrasound and vascular tests*Perform V02max testing for all lab research participants*Establish exercise routine and oversee weekly exercise training for specific research study participants*Oversee data collection and interpretation for multiple research studies*Interact regularly with Duke physicians regarding patient test results *Developed training manual for all new hires/interns*Oversee hiring, conduct new employee training, supervise interns

Duke Center For Living - Durham, Nc

*Performed and recorded exercise stress tests for the Human Performance Lab*Recruited potential patients for cardiac rehabilitation*Recorded and managed data collection and interpretation for the STRIDDE study*Performed VO2max testing for STRIDDE study*Supervised STRIDDE subject orientation

Greensboro/Winston-Salem, North Carolina Area

*Served as director of rehabilitation program (Project HOPE, Helping Older People Exercise) for adults 50+ with cardiac and pulmonary medical conditions*Successfully doubled enrollment in program over the course of two years*Designed and implemented customized exercise plans for program participants*Oversaw hiring and trained new hires upon acceptance to the program*Taught/monitored undergraduate students working with the program and provided assistance with their learning and development throughout the semester

Masters, Exercise Physiology

Bs, Sports Medicine