Joselin Soler, Msph Email & Phone Number

- Review study protocols, especially section(s) pertaining to data collection and data management (i.e., patient treatment, supportive care, specimen submission, patient follow-up, etc.), ensuring that the database is designed to accurately capture the data required to meet the study aims.- Coordinate with the study committee and study team on CRF development and study set-up timelines, ensuring study activation is within mandated deadlines.- Design the CRFs and data validations (i.e., edit checks) required for assigned COG studies in collaboration with study committee and study team, ensuring consistency with the protocol, consent form documents and compliance with internal standard operating procedures (SOPs).- Create common data elements (CDEs) as needed to capture essential research data for the study, or ideptify appropriate CDEs from existing repositories, following established guidelines and procedures.- Lead CRF review activities with the study committee and study team, including presentation of CRFs to the COG CRF Review Committee for potential data collection and/or management issues.- Perform User Acceptance Testing within the study EDC, including end user screen testing, refinement, documentation and release of finalized electronic CRF forms adhering to the established development procedures.- Create an integrated study data management plan (DMP) in conjunction with study team members, based on the study specific CRFs and data management standards.- Review protocol amendments and determine required changes to the CRFs or study DMP.Coordinate with study team on amendment timelines, CRF change implementation, and site communications.- Maintain and monitor the conduct of active trials, including managing patient enrollments/randomizations and opening, closing, or suspending studies, as required, according to established departmental SOPs and study DMPs.

Phases 2+ studies Study population: Pediatrics (I.e healthy infants, adolescents) and adults.Indication: Pediatrics- Vaccine study (varying from Meningococcal, pneumococcal and RSV).Adults- Investigational product that observes outcomes in cardiovascular health, type 2 diabetes, etc.- Collaborates with the Principle Investigator and Sub-investigator to review and verify required source documents in subject’s medical record to confirm study eligibility.- Conducts interviews to assess the subject’s ability and willingness to follow and complete study procedures and visits.- Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately.- Maintains patient screening enrollment logs.- Timely data entry, query solution, AE and SAE reporting. - Randomize subjects and dispense Investigational Product. When appropriate, prepare and administer Investigational Product.- Receive Investigational Product and maintain inventory of Investigational Product at a site level and subject level.- Performs phlebotomy to collect, process and ship samples as required.- Applies knowledge of study design to assist in evaluation of protocol feasibility at the site.- Create source documents to capture the correct data per protocol and eCRF guidelines. - Perform regulatory maintenance pertaining to study start up, Continuing Reviews, close-out requirements and relevant communication print-outs for multiple research studies and sites.- Ensure Investigator Site File is up-to-date with all forms- IRB interaction, updated FDA 1572, Financial Disclosure Form, Delegation of Authority log, site training log, etc.- Review study contract to assure Sponsor is being billed appropriately. - Attends and participates in investigator meetings as directed.- Prepares source documents and regulatory binders for routine monitoring visits and sponsor audits.

Phase 2+ studies Study population: Hepatology, focusing on PSC and PBC.- Collaborated with principal investigators and co-investigators to enroll clinical trial patients.- Conducted study visits.- Overall compliance with the policy and procedures for conducting good clinical trials.- Screened, consented and enrolled study participants.- Collected, processed and stored samples for research.- Medication compliance tracking and coordinated protocol procedures.- Collected and reported all patient reported adverse drug reactions and other serious adverse events.- Patient education and follow-up per protocol guidelines.- Routine meetings with monitors to reconcile data management issues.- Participated in investigator’s meetings.- Prepared and submitted compliance documentation for the institutional review board.- Submitted to the Human Research Subjects Portal for UCH-RSS review and approval.- Maintenance of databases.- Abstracted data from patient charts and electronic medical records.

Phase 1+ studies Indication: Oncology- Assisted the Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.- Assisted in the completion of protocol specific documents. Obtain relevant medical information from patient clinic charts/medical records. Maintain logs/progress reports to track both currently enrolled as well as follow-up participants. Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.- Entered data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.- Assisted the Clinical Study Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.- Ensured that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.

- Produced graphs, figures, and tables for dissemination of project findings using Excel, SPSS, and SAS.- Performed literature reviews and chart reviews.- Managed IRB protocols, consent forms, and created focus group scripts.- Build and manage REDCap surveys.- Reviewed and extract data from patient's Electronic Medical Record.

Master Of Science In Public Health (Msph), Epidemiology

Bachelor’S Degree, Public Health; Minor In English Literature