Experience

TRIO-US, Inc.

• United States
• Research Services
• 1 - 100 Employee

• Clinical Trial Manager

  • Sep 2022 - Present

  • Manage the trial master file (TMF) on behalf of the sponsor. • Liaise with data management and medical monitoring team to ensure all documents for TMF is collected and filed. Notify of any gaps or missing documents. • Manage site activation activities and direct the distribution of study materials • Provide oversight and execution of study-specific training, including but not limited to, protocol, case report forms, study specific specimen handling procedures, and regulatory… Show more • Manage the trial master file (TMF) on behalf of the sponsor. • Liaise with data management and medical monitoring team to ensure all documents for TMF is collected and filed. Notify of any gaps or missing documents. • Manage site activation activities and direct the distribution of study materials • Provide oversight and execution of study-specific training, including but not limited to, protocol, case report forms, study specific specimen handling procedures, and regulatory processes • Report weekly to sponsor on subject accrual, trial progress, site issues or needs, and other key performance indicators for the study as directed by sponsor. • Oversee patient eligibility review and study specific inbox management • Developing and implementing study-specific risk-based monitoring (RBM) plan(s) according to relevant FDA guidance and protocol requirements, as applicable. • Review site provided CAPAs and submit to sponsor for approval. Upon sponsor approval, distribute to study monitor to implement with site. • Ensure adequate coverage of monitoring activities for each study • Create and execute training materials for monitors • Cross cover for monitors to conduct interim monitoring visits, SIVs, or closeout visits as needed • Review and approve all monitoring follow-up reports prior to distribution to sites and sponsors. • Inform sponsor of any issues noted from the monitors and implement resolution as agreed upon with sponsor

• Clinical Research Monitor

  • Sep 2021 - Present

  Westwood, California, United States Oversee the progress of assigned clinical trials and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), IRB requirements, and the applicable regulatory requirement(s) to ensure study subject safety. - Proper use and management of investigational medicinal product, and data integrity. - Ensures the trial is conducted and documented properly through a combination of remote data… Show more Oversee the progress of assigned clinical trials and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), IRB requirements, and the applicable regulatory requirement(s) to ensure study subject safety. - Proper use and management of investigational medicinal product, and data integrity. - Ensures the trial is conducted and documented properly through a combination of remote data review and on-site monitoring visits including SIV, IMV for source data verification, regulatory compliance and IMP accountability and management, and close out visits. - Act as the main line of communication between the sponsor and the investigator. - Overseeing and performing monitoring of clinical trial(s).



Children's Hospital Los Angeles (CHLA)

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Consortia Coordinator

  • Dec 2017 - Sep 2021

  Los Angeles, California •Manage and coordinate Phase I,II, III Government and Pharmaceutical protocols • Act as the liaison between the Consortia Medical Director and Study Chairs for protocol development, DSMC/DSMB, etc. • Design Case Report Forms to accurately capture the objectives of the protocol for accurate data analysis; have complete understanding of the protocol to provide guidance to participating sites to ensure protocol endpoints are being met • Provide logistics for study drug distribution in… Show more •Manage and coordinate Phase I,II, III Government and Pharmaceutical protocols • Act as the liaison between the Consortia Medical Director and Study Chairs for protocol development, DSMC/DSMB, etc. • Design Case Report Forms to accurately capture the objectives of the protocol for accurate data analysis; have complete understanding of the protocol to provide guidance to participating sites to ensure protocol endpoints are being met • Provide logistics for study drug distribution in conjunction with the Consortia Administrator • Review study progress reports for accuracy and perform follow up with the appropriate sites as needed • Perform data review in the electronic data capture system (eCRF) for accuracy and completeness • Assist with the development and review of key project documents such as the protocol, informed consent and CRF guidelines • Prepare and file IND submission to FDA, including but not limited to Annual Reports, SUSARS, Amendments, etc. • Responsible for comprehensive IRB submissions: new applications, amendments, adverse event/protocol deviation reporting • Disseminate the CHLA IRB approved protocol to all participating sites for their respective IRB review and approval; ensure that regulatory binder is maintained with appropriate essential documents from all sites • Register/enroll/randomize patients into the research study • Conduct SIV, IMV, and Close Out Visits in conjunction with Sponsors • Other duties as assigned Show less



NRI - National Research Institute

• Papua New Guinea
• Research Services
• 1 - 100 Employee

• Project Manager

  • May 2016 - Nov 2017

  Wilshire Location The Project Manager/Lead CRC is responsible for managing and coordination of mainly Phase I-IV studies Pharmaceutical protocols; is responsible for, and critically important to the overall operational management of clinical research activities. This position reports to the Site Director, also is responsible for hiring, supervising, and organization of a team of clinical research coordinators (CRC's) which includes assessing workload, assignments and oversight of data collection and clinical… Show more The Project Manager/Lead CRC is responsible for managing and coordination of mainly Phase I-IV studies Pharmaceutical protocols; is responsible for, and critically important to the overall operational management of clinical research activities. This position reports to the Site Director, also is responsible for hiring, supervising, and organization of a team of clinical research coordinators (CRC's) which includes assessing workload, assignments and oversight of data collection and clinical trial management in order to accomplish implementation of protocols within the program that meet federal, state and institutional policies and guidelines. Project Managers attend scientific meetings • Participate and scheduled pre-study selection visits, site initiation visits, monitoring vistas and close-up visits. • Web conferences • Supervises multiple clinical trials. • Write a summary of the given protocol study outline using standard templates. • Team members include a minimum of 3 coordinators and laboratory technicians • Design worksheet for protocols using standard templates. • Teach the worksheet to the protocol team members. • Supervises and document the quality and efficiency of the work completed throughout the clinical trial by the coordinators and laboratory technicians. • Responsible to answer questions that arise from the team members • Project Manager is the liaison between the pharmaceutical sponsor and our Worksite. • Teaches and document the team the required steps or necessary revisions. • Training Form is utilized to document clinical trial, in-service required by Pharmaceutical sponsors and federal regulations • Training forms includes date and initials of attendees for initial and follow up in- service • Throughout the clinical trial the Project Manager directing and supervising her/his team members. • Reduction of duties, promotions or termination is dependent on ongoing supervision and evaluation of the members of each clinical trial. Show less



PAREXEL

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Coordinator II

  • Aug 2014 - Apr 2016

  Glendale Developing new methods and processes to improve efficiency and implement process improvement strategies within the clinical unit. Reviewing study protocols, identifying operational risks with sponsors to ensure successful execution of studies. Responsible for study resource allocation, optimizing effective planning and utilization of resources. Mentoring new CRCs, and overseeing patient enrollment and clinical activities. Ensuring compliance with International Conference on Harmonisation's Good… Show more Developing new methods and processes to improve efficiency and implement process improvement strategies within the clinical unit. Reviewing study protocols, identifying operational risks with sponsors to ensure successful execution of studies. Responsible for study resource allocation, optimizing effective planning and utilization of resources. Mentoring new CRCs, and overseeing patient enrollment and clinical activities. Ensuring compliance with International Conference on Harmonisation's Good Clinical Practice Guidelines (E6), FDA 21 Code of Federal Regulation (CFR) Parts 11, 50, 56, 312, 812 and FDA 45 CFR Part 46, as well as other regulatory guidelines (Japanese-GCP for ethno bridging studies, etc.). Responsible for data quality and protocol compliance excellence demonstrated in study start up, execution, and closeout through accuracy of in-house Electronic Medical Records System or paper source documentation. Responsible for the assistance of sponsor audits and regulatory inspections.

• Clinical Operations Manager

  • Feb 2014 - Aug 2014

  Glendale • Possesses thorough knowledge of all current study protocols. • Manages all activities and staffing issues related to Department and the laboratory including hiring, training, scheduling, coaching/counseling, performance evaluations and staff terminations. • Reviews and approves all timesheets. • Meets regularly with Managers to discuss staffing for upcoming studies, sharing of staff between departments, and overtime reports. • Authorizes all hiring, transfers, performance… Show more • Possesses thorough knowledge of all current study protocols. • Manages all activities and staffing issues related to Department and the laboratory including hiring, training, scheduling, coaching/counseling, performance evaluations and staff terminations. • Reviews and approves all timesheets. • Meets regularly with Managers to discuss staffing for upcoming studies, sharing of staff between departments, and overtime reports. • Authorizes all hiring, transfers, performance reviews, increases, and terminations in the Department in conjunction with the Director, Clinical Operations or the Director – Early Phase, Senior. • Attends managerial/operational meetings as required. • Meets regularly with the Director, Clinical Operations or the Director, Early Phase, Senior. • Leads departmental meetings regularly as appropriate. • Interfaces with key departments to discuss status of current studies at CCT, as well as significant staffing, hospital and advertising issues. • Explores potential in upcoming studies, methods to continue to provide sponsors with the highest quality data, increasing clinic efficiency and directions for future growth. • Provides clinical input on protocols in development. Identifies which protocols can or cannot be done feasibly/profitably at CCT. • Manages all aspects of clinical operations at the unit/site. • Supervises additional support staff and ancillary staff as required by the unit/site. • Supervises Pharmacy and Laboratory activities as required by the unit/site. • Evaluates proposed protocols and provides feedback to Business Operations on clinical feasibility. • Provides information to Business Operations/Business Development to complete proposals/budgets upon request. • Provides continued contact with the Sponsor for duration of the clinical study including entertaining Sponsor during site visits. • Establishes and maintains relationships with hospital or facility representatives.

• L.V.N. / Clinical Research Coordinator

  • Jan 2012 - Feb 2014

  • Reviews and understands the study protocol and seeks clarification of any protocol issues. • Assesses training needs for the Study Teams and arranges for any additional training needed for study protocol. • Orients and trains new Study Team members. • Provides analysis for study protocol inclusion/exclusion criteria, screening packets, lab requirements, flow sheets and equipment needs. • Creates study specific paperwork. • Prepares staffing requirements with the assistance of… Show more • Reviews and understands the study protocol and seeks clarification of any protocol issues. • Assesses training needs for the Study Teams and arranges for any additional training needed for study protocol. • Orients and trains new Study Team members. • Provides analysis for study protocol inclusion/exclusion criteria, screening packets, lab requirements, flow sheets and equipment needs. • Creates study specific paperwork. • Prepares staffing requirements with the assistance of the Department Managers and/or the Nurse Supervisor. • Trains Study Team members on study rating(s) scale(s) as required and performs rating scales as needed. • Supervises study participant enrollment or works with enrollment department tracking enrollment status to ensure timelines are met. • Oversees potential study participant scheduling and screening. • Updates/Maintains ClinCenter and/or visit tickets. • Signs-off study participant visits. • Ensures basic study participant safety is provided within the clinic for outpatient visits and/or hospital for inpatient study periods. • Communicates with physicians and relevant Clinical Staff in evaluating study participant status. • Monitors study participant test results. • Collects Adverse Events for Pharm.D. • Ensures all medical equipment (i.e., crash cart, ECG machines, dynamaps, etc.) is functioning properly. • Assists in tracking equipment calibration during inpatient study periods at the hospital. • Serves as liaison between CCTMG and the hospital for inpatient study periods. • Remains on-call to handle all after-hours study participant issues. • Maintains contact with Sponsor and prepares appropriate documentation of such contact (e.g. letter, progress notes, memos to file.) • Hosts pharmaceutical representative visits. • Attends outside Investigator meetings as requested (may require travel) and in-house Investigator meetings. •

• L.V.N. / Clinical Research Associate

  • May 2011 - Dec 2011

  Glendale, California • Performs appropriate psychometric and efficacy testing according to study protocol. • Receives authorized sign-off to verify accuracy of all study participant visits. • Prepares/monitors study supplies and stock levels in clinic/hospital. • Labels, inventories and sends plasma samples. • Problem solves study participant issues as they arise. • Assumes appropriate role with study participants and caregivers. • Attends and assists with start-up and… Show more • Performs appropriate psychometric and efficacy testing according to study protocol. • Receives authorized sign-off to verify accuracy of all study participant visits. • Prepares/monitors study supplies and stock levels in clinic/hospital. • Labels, inventories and sends plasma samples. • Problem solves study participant issues as they arise. • Assumes appropriate role with study participants and caregivers. • Attends and assists with start-up and flowsheet meetings. • Completes Case Report Forms (CRF) in a timely manner. • Assures quality and accuracy of source and CRF documentation. • Complies with Quality Management (QM) department guidelines and performs corrections for QM, CRC and Monitor/Sponsor Representative in a timely manner. • Assists with Monitor visits (i.e., room set up, etc.). • Follows medical records procedure. • Ensures basic study participant safety is provided. • Maintains accurate accountability for petty cash. • Identifies issues that need Sponsor approval and brings these to the attention of the CRC. • Exhibits professional demeanor at all times in external interactions with Sponsors/Sponsor Representatives. • Maintains supportive, flexible manner internally with management, coworkers/team members. • Maintains and updates knowledge of Clinical Operating Guidelines and their proper application. • All other duties as assigned.