Cathy K Email and Phone Number

• Performed on-site and remote monitoring and study closure activities across multiple protocols. • Managed and trained site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion, and EDC system. • Participate in the investigator recruitment process.• Oversee and report on the conduct of clinical trials at the site level including site visit reports and updates to electronic management systems. •… Show more • Performed on-site and remote monitoring and study closure activities across multiple protocols. • Managed and trained site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion, and EDC system. • Participate in the investigator recruitment process.• Oversee and report on the conduct of clinical trials at the site level including site visit reports and updates to electronic management systems. • Respond to site queries and escalated issues in accordance with processes and timelines. • Ensure timely reconciliation of data queries and implementation of process improvement/corrective action when needed. • Generate confirmation letters, monitoring visit trip reports, and follow up letters in a timely manner for each monitoring visit. • Ensure proper study documentation is maintained and archived in the TMF. Show less

• Conducted PSV, SIV, RMV, and COV • Performed CRF review; query generation and resolution against established data review guidelines • Conducted study initiation visit to ensure the Principal Investigator and other site personnel understand their duties related to the clinical trial protocol • Performed pre-site inspections to verify eligibility; visit consists of coordinating with the investigator, evaluate the staff, and evaluates the system as a whole… Show more • Conducted PSV, SIV, RMV, and COV • Performed CRF review; query generation and resolution against established data review guidelines • Conducted study initiation visit to ensure the Principal Investigator and other site personnel understand their duties related to the clinical trial protocol • Performed pre-site inspections to verify eligibility; visit consists of coordinating with the investigator, evaluate the staff, and evaluates the system as a whole • Provided guidance and oversight to clinical staff to ensure clinical research projects complied with internal SOPs and ICH-GCP regulations • Reviewed all case report forms and compare to source documents • Directly responsible for reviewing regulatory documents, tracking in database and filing in clinical master files • Ensure the protection of subjects, by verifying informed consent procedures and protocol requirements are adhered to according to the regulatory requirements Show less

• Served as key contact person for site personnel to address operational issues. • Participated in the investigator recruitment process. • Performed compliance reviews on inform consent process documentation. • Coordinated and managed the activities of investigative sites to ensure compliance with study protocol requirements. • Reviewed subject’s charts for data integrity and adherence to the ICH/GCP. • Mentored CRAs new to the position or company… Show more • Served as key contact person for site personnel to address operational issues. • Participated in the investigator recruitment process. • Performed compliance reviews on inform consent process documentation. • Coordinated and managed the activities of investigative sites to ensure compliance with study protocol requirements. • Reviewed subject’s charts for data integrity and adherence to the ICH/GCP. • Mentored CRAs new to the position or company. • Evaluated clinical data and coordinated data query resolutions. • Conducted clinical site and data monitoring and completed monitoring visit reports. • Performed investigational product inventory. Show less

• Performed participants screening, enrolment, study activities, and communication. • Ensured all protocol procedures are ordered and completed as specified in the protocol. • Provided research study education to participants as part of the study protocol. • Obtained inform consent by following policy, procedure, and regulatory requirements. • Completed data entry and ensured data integrity. • Monitored and reported any adverse events to the investigators… Show more • Performed participants screening, enrolment, study activities, and communication. • Ensured all protocol procedures are ordered and completed as specified in the protocol. • Provided research study education to participants as part of the study protocol. • Obtained inform consent by following policy, procedure, and regulatory requirements. • Completed data entry and ensured data integrity. • Monitored and reported any adverse events to the investigators and other members of the study team. • Completed documentation as needed within the medical record. • Scheduled study specific visits in conjunction with ancillary departments. • Participated in required teleconferences, on-site meetings, and off-site investigator meetings, as required.• Monitored compliance throughout all study activities and engaged compliance oversight as needed. Show less