Associate Manager, Clinical Operations

• Mar 2022 - Present

Senior Clinical Trial Associate

• Dec 2019 - Present

• Assist the Clinical Operations Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness. Inform the Clinical Operations Manager/Project Team on any outstanding document(s).• Assist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third-party vendors.• Participate in project management meetings and provide an overview of TMF status, clinical study administration, resources, quality, and workload on a regular basis.• Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes. • Communicate effectively with clinical study administration vendors (Functional Service providers etc.).• Assist in coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.• Assist in data listing review and clinical study report listing review.• Independently tracks and oversees study start-up activities and oversight of third-party vendors• Communicating key issues and mitigation to relevant cross-functional stakeholders. • Leads the coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.• Actively participates in data listing and/or clinical study report listing review• Contributes to creation of relevant study specific plans, tools and trackers.

Senior Clinical Trial Associate

• Apr 2019 - Dec 2019

• Conduct co-monitoring visits and assists in the oversight of CRAs• Support eTMF set-up and management, ongoing quality review, and final reconciliation of study documents in audit ready condition according to company SOPs and DIA TMF Reference Model• Perform study site management activities, including tracking of site-related activities, receipt verification, handling, accounting, and availability of investigational products and supplies• Liaise with other departments regarding issues relating to essential documentation and archiving• Support the timely identification of problems or issues that could affect the clinical study results or timely completion of the trial• Prepare or provide input into status reports for senior management updates• Create, finalize, and distribute meeting agendas and minutes• Keep the Clinical Operations lead informed of project process

Senior Clinical Research Coordinator

• Sep 2017 - Apr 2019

• Ensured timely conduct of clinical trials by managing daily operations of subject communication, data management, and coordination of subject visit schedules and related assessments• Conducted qualification, initiation, interim, and close out monitoring visits• Led department in the creation of paper TMF for all studies and maintained it in audit ready condition• Created Data Management and Clinical Monitoring Plans, Project Criteria, Work Instructions, CRFs, and CRF Completion Guidelines• Managed site IRB submissions, data entry, and inventory requests including IP and ancillary supplies• Curated data with query generation (paper and electronic), review and close-out• Assisted in the development and review of Informed Consents Forms• Conducted software validations including Design Qualification (DQ) and Performance Qualification (PQ)• Participated in internal Quality Assurance audits according to SOPs and applicable regulations

Clinical Research Coordinator

• Apr 2017 - Aug 2017

• Managed multiple high enrolling protocols (Phases II & III) simultaneously• Developed CRFs for source data collection and entered data/resolved queries in the EDC• Maintained IP accountability and inventory of ancillary supplies• Performed regular internal audits of regulatory documents to identify gaps in documentation and assisted in the creation and implementation of CAPAs• Assembled and prepared laboratory kits for biospecimen collection• Coordinated and participated in study activities such as IMs, SIVs, and remote and on-site IMVs• Completed pre-randomization forms to sponsors for approval and randomized subjects in the IWRS/IRT• Trained staff and served as a liaison between sponsors and multiple in-house departments (e.g. regulatory)

Clinical Research Coordinator

• Aug 2015 - Mar 2017

• Screened, enrolled and randomized subjects according to protocol• Administered informed consent and psychological scales and study assessments• Completed and maintained source documentation including CRFs and regulatory documents• Resolved sponsor queries and inquiries from Institutional Review Board (IRB) audits• Collected, tested, stored and shipped biological specimens while maintaining inventory of supplies• Monitored participants’ vital signs according to blood pressure grades• Transcribed physician progress notes into the EDC• Developed and executed various recruitment methods including online postings, radio and televisioncampaigns that increased study enrollment• Served as a liaison to sponsors, physicians, pharmacists, psychiatric residents, and medical center personnel

Research Assistant

• Jun 2014 - Jun 2015

• Administered interviews and prepared assessments to pediatric subjects• Performed electrocardiograms on pediatric subjects • Administered interviews and prepared assessments to pediatric subjects• Performed electrocardiograms on pediatric subjects

Research Assistant

• Jan 2014 - Jun 2015

• Obtained informed consent and debriefed participants• Pilot tested procedures and transcribed and managed video/audio recordings for graduates’ thesis projects • Obtained informed consent and debriefed participants• Pilot tested procedures and transcribed and managed video/audio recordings for graduates’ thesis projects

Research Assistant

• Jan 2013 - Jun 2015

• Administered psychosocial questionnaires to participants and collected blood via finger stick• Managed cleaning activities of data files (> 500 subjects) for coding and data entry using SPSS and Qualtrics• Assisted with manuscript submissions by conducting literature reviews using Google Scholar and PubMed • Administered psychosocial questionnaires to participants and collected blood via finger stick• Managed cleaning activities of data files (> 500 subjects) for coding and data entry using SPSS and Qualtrics• Assisted with manuscript submissions by conducting literature reviews using Google Scholar and PubMed

Peer Mentor/ Educator

• Sep 2014 - Mar 2015

• Developed and executed professional workshops to a group of up to 25 students. • Educated new students about the resources and services offered.• Coordinated and facilitated social and educational programs.• Met with students individually to discuss progress. • Assisted with creation of the workshop syllabus. • Developed and executed professional workshops to a group of up to 25 students. • Educated new students about the resources and services offered.• Coordinated and facilitated social and educational programs.• Met with students individually to discuss progress. • Assisted with creation of the workshop syllabus.