Senior Clinical Research Associate

• Jan 2021 - Present

Primary point of contact for the Project Manager during start-up on allocated projects.Proactively forecast submission/approval timelines and ensures adherence. Ensure the site contract and budget are on track to meet the Site Initiation forecast timelines.Primary liaison for study and site (post SSU completion) management issues, escalating to PM as required.Responsible for maintenance of essential study documents in the Trial Master File., including the creation and maintenance of project-specific administrative documents. Maintaining accurate updated clinical trial management systems (CTMS). Identifying items and issues for review and/or follow-up by the CRAs and/or project management.Manage time and project requirements based on study contract.Work with internal and external customers/vendors to meet project specific goalsDraft and review of Informed Consent Form templatesDraft and review local SOPs, Associated Documents, and Job Aides.Support creation of internal training materials on for local legislation requirements.Assists with mentoring and training staff.

Clinical Study Associate

• Mar 2020 - Apr 2021

• Manage Phase I through 4 Oncology Trials including registries and observational clinical study(ies) conduct to support completion per established project team goals and objectives• Support study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study• Manage creation and updates to protocols, amendments, ICFs in collaboration with Medical Writing, Regulatory, Stats and Data Management functions• Manage study set-up including but not limited to eCRF design, protocol preparation, informed consents, investigator selection, systems (e.g., CTMS, IVR, etc.), study related operational manuals, training materials, and various study plans (e.g., visit logs, drug inventory, monitoring plan, etc.)• Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed• Management of study completion activities including data review and clinical study report review• Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and or submission of regulatory documents to the TMF and ongoing document reconciliation• Perform Clinical Study Oversight of Sponsor and Vendors as per Clinical Study Oversight Plan

Vault eTMF Analyst, Operations

• Aug 2019 - Mar 2020

• Managed the Veeva Vault eTMF system as Business Administration.• Collaborated with Veeva Team on migration plan, execution, and implementation.• Managed multiple systems integration between CTMS, Veeva Vault, EDC, and ect.• Project Lead on eTMF vault migration to Abbvie system.• Core member on Business process alignment between PCYC and Abbvie.• Evaluate End to End Business Process and standardize process.• Provided training/mentoring activities for current and new members.• Conducted analysis on existing metrics/dashboards related to the TMF Health.• Proactively identifies areas for process improvement.• Trainer, train and on board CROs to AbbVie Veeva Vault eTMF.• Identifying, selecting, and monitoring performance of investigational sites for clinical studies• Investigating queries, monitoring discrepancies• Managing investigational product (IP) accountability and reconciliation process• Negotiating and managing the budget and the payments• Overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to Clinical Operations Manager• Performing clinical data review of data listings and summary tables, including query generation• Performing initial review of CRO and other third party study vendor invoices• Planning and conducting investigator meetings• Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team• Reviewing or approving of IP release packages• Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits• Writing or contributing to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents

Lead Clinical Research Associate

• Jun 2018 - Aug 2019

• Identifying, selecting, and monitoring performance of investigational sites for clinical studies• Investigating queries, monitoring discrepancies• Managing investigational product (IP) accountability and reconciliation process• Perform data review in accordance with Data Management Plan• Verify data quality against source documentation Generate EDC data query on missing and inaccurate data in accordance with the clinical trial protocol• Escalate quality issues on data to Data Manager• SME on Data Validation, Data QC Review and Data Management for study trial• Plan and organize educational, scientific meetings for CRA (s), trial site personnel, as well as other relevant medical and healthcare personnel.• Clinical trial monitoring, including study start up, study initiation through closeout, as well experience in International, and Domestic studies.• Therapeutic experience includes: Oncology, Respiratory, Infectious Disease, Gastroenterology, Endocrinology (Obesity), Rheumatoid Arthritis, Vaccine, Cardiology and device.• Responsible for protocol development, writing proposals, data analysis, project-based assignments, progress reports and manuscripts, creating informational and recruitment materials, day to day patient activities, as well as acting as a liaison with other departments and community clinics/agencies for implementation of studies.• Assure compliance with state and federal regulatory guidelines.• Oversee the quality of the medical and clinical research data.

Staff Research Associate II

• Jul 2017 - Jun 2018

• Responsible for multiple study protocols for the UCSD Electrophysiology Program.• Under the supervision of the PI and research manager, responsibilities included coordination and oversight of start-up procedures, study implementation, recruitment, subject screening, enrollment, and maintenance of subjects throughout the study.• This includes coordinating with various organizations including the FDA, UCSD HRPP, CRO’s, Sub-contractors and/or Pharmaceutical/Device companies as well as assisting multiple PIs with the day to day aspects of trials.• Responsible for protocol development, writing proposals, data analysis, project-based assignments, progress reports and manuscripts, creating informational and recruitment materials, day to day patient activities, as well as acting as a liaison with other UCSD departments and community clinics/agencies for implementation of studies.• Assure compliance with state and federal regulatory guidelines.• Oversee the quality of the medical and clinical research data.• Developing, updating and refining Standard Operating Procedures that serve as the basis for the Program at the site; developing and maintaining a study database, including monitoring and quality control of data.

Clinical Research Coordinator

• Aug 2015 - Jul 2017

• Served as primary study coordinator for research protocols at affiliated hospitals or in the outpatient clinic setting as assigned by the PI.• Directed the conduct of clinical studies to ensure adherence to the research protocol and provides bimonthly updates to Principal Investigator on study progress.• Screening patient records, databases, and physician referral summaries for identification of prospective candidates for research protocols.• Interview prospective subjects for participation in investigations and obtain informed consent.• Participated in initiation visits/investigator's meetings for assigned clinical trials and implemented these trials according to a deadline as per sponsor requirements.• Developed study working folders for assigned protocols to outline guidelines for protocol compliance and to assure complete source documentation.• Educated human subjects for participation in investigations.• IWRS/EDC data entry, study drug accountability.• GCP/ICH certified,• CITI certified. • Responsible for eTMF document upload and maintenance including but limited to:- CTMS Updating- Assist in eTMF Audit Readiness- Site Doc Maintenance- Assist Site Payments per Global Finance standards- Performs other duties as assigned by management to support site activation team needing collaborative support

Study Coordinator

• Aug 2014 - Jul 2017

• Responsibilities include: Partner with the study teams to develop TMF Maps/Indexes and Plans Facilitate the creation of study-specific TMFs• Serve as the primary point of contact for study-specific TMF questions• Support the study teams and TMF Content Owners to ensure TMF compliance with applicable Standard Operating Procedures (SOPs)• Perform the processes associated with receiving, classifying and filing documents in the TMF• Perform TMF Quality Control (QC) against specified criteria• Prepare TMF metrics, such as percent completeness and quality of TMF documents and content submitted• Participate in study team meetings and present TMF metrics updates, as applicable• Provide guidance to the study teams on best practices for record handling, retrieval, and archival procedures• Manage the TMF archival process according to applicable SOPs• Prepare, transition and manage TMFs to/from long-term archiving facility• Support the study teams in TMF document retrieval during audits and regulatory authority inspections• Manage the coordination of the transfer of study-specific TMFs from CROs• Ensure TMF file room security rules are enforced per working practices• Contribute to TMF procedures• Coordinate TMF training to new and existing study team members, as applicable• Serve as a clinical document subject matter expert on initiatives and working groups

Clinical Documentation Specialist

• Jun 2013 - Jul 2014

• Transcribing various medical reports that include histories and physical examinations, progress reports, emergency room notes, consultations, operative reports, discharge summaries, clinic notes, referral letters, radiology reports, pathology reports, and various other documents.• Editing a variety of correspondence, reports, memoranda, and other material requiring judgment as to content, accuracy, and completeness.

Medical Administrative Assistant

• Oct 2008 - May 2013

Research Assistant

• Jan 2008 - Sep 2008

Resident Physician

• Feb 2007 - Sep 2007