Clinical Trial Manager

• May 2021 - Present

• Experience managing Phase 1 and 2 clinical trials. • Provides study leadership and effectively collaborates with other departments and functional groups to meet study timelines and corporate goals. • Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, study manuals and plans, safety review committee charters. • Manages study-specific CROs, vendors and contractors. • Prepares study updates and tracking… Show more • Experience managing Phase 1 and 2 clinical trials. • Provides study leadership and effectively collaborates with other departments and functional groups to meet study timelines and corporate goals. • Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, study manuals and plans, safety review committee charters. • Manages study-specific CROs, vendors and contractors. • Prepares study updates and tracking information for departmental / company meetings. • Proactively identifies and communicates study-related issues and facilitates discussion of potential solutions that can be implemented by the team. Show less • Experience managing Phase 1 and 2 clinical trials. • Provides study leadership and effectively collaborates with other departments and functional groups to meet study timelines and corporate goals. • Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, study manuals and plans, safety review committee charters. • Manages study-specific CROs, vendors and contractors. • Prepares study updates and tracking… Show more • Experience managing Phase 1 and 2 clinical trials. • Provides study leadership and effectively collaborates with other departments and functional groups to meet study timelines and corporate goals. • Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, study manuals and plans, safety review committee charters. • Manages study-specific CROs, vendors and contractors. • Prepares study updates and tracking information for departmental / company meetings. • Proactively identifies and communicates study-related issues and facilitates discussion of potential solutions that can be implemented by the team. Show less

Sr. Clinical Research Associate

• Sep 2019 - May 2021

• Assisted Clinical Operations Lead with global startup and maintenance of pivotal phase III studies. • Managed Contract Research Organizations (CRO) personnel and study sites to ensure studies are in compliance with the protocol, GCP/ICH guidelines, and overall clinical objectives. • Supervised and support monitoring related activities conducted by CROs. • Prepared and maintain study related documents such as study plans, eCRF completion guidelines, and training materials. •… Show more • Assisted Clinical Operations Lead with global startup and maintenance of pivotal phase III studies. • Managed Contract Research Organizations (CRO) personnel and study sites to ensure studies are in compliance with the protocol, GCP/ICH guidelines, and overall clinical objectives. • Supervised and support monitoring related activities conducted by CROs. • Prepared and maintain study related documents such as study plans, eCRF completion guidelines, and training materials. • Conducted monthly reviews of data according to data review/monitoring guidelines. • Prepared and present study-specific slides during internal study team meetings and Investigator meetings.

Clinical Research Associate

• May 2019 - Sep 2019

Clinical Operations

• Nov 2018 - Apr 2019

• Perform quality control reviews of regulatory documents to ensure completeness and accuracy. • Organize and maintain electronic (in Veeva Vault) and paper Trial Master Files including preparation for internal/external audits and final reconciliation • Maintain accurate and current tracking systems. • Coordinate and ensures that monthly payment processes are completed accurately and on time. • Review for accurate and consistent filing of TMF documents. • Assist with… Show more • Perform quality control reviews of regulatory documents to ensure completeness and accuracy. • Organize and maintain electronic (in Veeva Vault) and paper Trial Master Files including preparation for internal/external audits and final reconciliation • Maintain accurate and current tracking systems. • Coordinate and ensures that monthly payment processes are completed accurately and on time. • Review for accurate and consistent filing of TMF documents. • Assist with taking and issuing meeting agendas and minutes for weekly clinical team minutes. Show less • Perform quality control reviews of regulatory documents to ensure completeness and accuracy. • Organize and maintain electronic (in Veeva Vault) and paper Trial Master Files including preparation for internal/external audits and final reconciliation • Maintain accurate and current tracking systems. • Coordinate and ensures that monthly payment processes are completed accurately and on time. • Review for accurate and consistent filing of TMF documents. • Assist with… Show more • Perform quality control reviews of regulatory documents to ensure completeness and accuracy. • Organize and maintain electronic (in Veeva Vault) and paper Trial Master Files including preparation for internal/external audits and final reconciliation • Maintain accurate and current tracking systems. • Coordinate and ensures that monthly payment processes are completed accurately and on time. • Review for accurate and consistent filing of TMF documents. • Assist with taking and issuing meeting agendas and minutes for weekly clinical team minutes. Show less

Sr. Intern-Clinical Research

• Aug 2018 - Nov 2018

• Collect and load all documents required for Institutional Review Board (IRB) submission into eProtocol (study personnel and all required docs, ICF, Protocol, etc). • Review Informed Consent Forms (ICF) to check for compliance • Convert other ICF's from other study sites to El Camino Hospital template. • Collaborate with coordinators to log all Serious Adverse Events (SAE) from EDC to Clinical Conductor (CTMS). • Log all SAE's and AE's onto Sponsor's database. • Collect and load all documents required for Institutional Review Board (IRB) submission into eProtocol (study personnel and all required docs, ICF, Protocol, etc). • Review Informed Consent Forms (ICF) to check for compliance • Convert other ICF's from other study sites to El Camino Hospital template. • Collaborate with coordinators to log all Serious Adverse Events (SAE) from EDC to Clinical Conductor (CTMS). • Log all SAE's and AE's onto Sponsor's database.

Medical Assistant

• Feb 2016 - Aug 2018

• Perform clinical duties in the Primary Care department with cross training in HIV, OBGYN, and Teen Clinic. • Interview patients to assess quality of life, measure and monitor vital signs, and record patients’ information onto electronic records. • Collaborate with Physicians to maintain and organize clinical documentation, order basic lab tests, perform EKG’s, review medication, sterilize tools, oversee data and specimen management, prepare supplies, and get patients ready for… Show more • Perform clinical duties in the Primary Care department with cross training in HIV, OBGYN, and Teen Clinic. • Interview patients to assess quality of life, measure and monitor vital signs, and record patients’ information onto electronic records. • Collaborate with Physicians to maintain and organize clinical documentation, order basic lab tests, perform EKG’s, review medication, sterilize tools, oversee data and specimen management, prepare supplies, and get patients ready for treatment-related tasks. • Monitor and screen patients due for preventative exams and schedule their appointments. • Administer subcutaneous, intradermal, and intramuscular injections. • Serve as liaison between patients and their associated insurance companies, external laboratory service providers like Covance, and other clinical sites. Show less • Perform clinical duties in the Primary Care department with cross training in HIV, OBGYN, and Teen Clinic. • Interview patients to assess quality of life, measure and monitor vital signs, and record patients’ information onto electronic records. • Collaborate with Physicians to maintain and organize clinical documentation, order basic lab tests, perform EKG’s, review medication, sterilize tools, oversee data and specimen management, prepare supplies, and get patients ready for… Show more • Perform clinical duties in the Primary Care department with cross training in HIV, OBGYN, and Teen Clinic. • Interview patients to assess quality of life, measure and monitor vital signs, and record patients’ information onto electronic records. • Collaborate with Physicians to maintain and organize clinical documentation, order basic lab tests, perform EKG’s, review medication, sterilize tools, oversee data and specimen management, prepare supplies, and get patients ready for treatment-related tasks. • Monitor and screen patients due for preventative exams and schedule their appointments. • Administer subcutaneous, intradermal, and intramuscular injections. • Serve as liaison between patients and their associated insurance companies, external laboratory service providers like Covance, and other clinical sites. Show less

Group Facilitator

• Jan 2016 - Jan 2017

• Managed a team of youth volunteers by providing direction, coordination, and consultation for all volunteer functions in order to enable them to serve members of the community. • Developed and implement training strategies and protocol for volunteer orientations. • Maintained accurate records and provided timely activity reports on volunteer participation. • Managed a team of youth volunteers by providing direction, coordination, and consultation for all volunteer functions in order to enable them to serve members of the community. • Developed and implement training strategies and protocol for volunteer orientations. • Maintained accurate records and provided timely activity reports on volunteer participation.

Medical Assistant Extern

• Aug 2015 - Sep 2015

• Obtained and processed patients' medical insurance information promptly and accurately. • Communicated with physicians and medical support staff to determine the need for patient services. • Interfaced directly with a diverse population of patients, and responding to various inquiries and concerns. • Managed front desk in areas of manual and computerized scheduling, billing, and medical/insurance. • Obtained and processed patients' medical insurance information promptly and accurately. • Communicated with physicians and medical support staff to determine the need for patient services. • Interfaced directly with a diverse population of patients, and responding to various inquiries and concerns. • Managed front desk in areas of manual and computerized scheduling, billing, and medical/insurance.

Clinical Research Intern

• Jun 2012 - Sep 2012

• Tested patients for vital signs and identified the normal range. • Obtained an understanding of the following diseases: Hypertension, Diabetes, Coronary Heart Disease, Osteoarthritis, Osteoporosis, and Obesity. • Assisted clinical research coordinators with administrative tasks. • Tested patients for vital signs and identified the normal range. • Obtained an understanding of the following diseases: Hypertension, Diabetes, Coronary Heart Disease, Osteoarthritis, Osteoporosis, and Obesity. • Assisted clinical research coordinators with administrative tasks.

Tutor

• Aug 2011 - Jun 2012

• Implemented various learning strategies to motivate struggling students. • Graded math and reading assignments in an efficient manner. • Maintained record of student test results in order to manage individual students’ progress. • Implemented various learning strategies to motivate struggling students. • Graded math and reading assignments in an efficient manner. • Maintained record of student test results in order to manage individual students’ progress.