Experience

The McConnell Group, Inc.

• Biotechnology Research
• 1 - 100 Employee

• Senior Clinical Research Coordinator

  • Nov 2010 - Present

  San Diego, CA Conduct neurology drug and imaging studies. Assist with writing study protocols. Supervise recruitment and subject enrollment. Audit and analyze data, prepare queries and write study reports. * Design and develop CRFs, Informed Consent Forms (ICFs), study questionnaires and brochures. * Review, critique and provide guidance on new proposals submitted to the IRB. * Work with investigators and providers to explore study interests and recruit subjects. * Assist study staff to adhere… Show more Conduct neurology drug and imaging studies. Assist with writing study protocols. Supervise recruitment and subject enrollment. Audit and analyze data, prepare queries and write study reports. * Design and develop CRFs, Informed Consent Forms (ICFs), study questionnaires and brochures. * Review, critique and provide guidance on new proposals submitted to the IRB. * Work with investigators and providers to explore study interests and recruit subjects. * Assist study staff to adhere to study protocols, ensuring data integrity and SOP compliance. * Use Access, Excel and SPSS to assemble, maintain, extract and perform statistical analyses of data. Show less



SAIC

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Sr. Clinical Researcher

  • Oct 2008 - Oct 2010

  Greater San Diego Area * Managed in-house operations of psychiatric clinical studies. * Wrote study protocols and developed study documents. * Prepared CRFs, informed consent forms, screening questionnaires, scientific reviews, study contracts and assessment scales. * Screened, recruited and enrolled subjects, obtained ICFs, conducted assessment intakes, and followed-up study subjects. * Facilitated regulatory submissions and ensured study compliance based on GCP guidelines.



INOVIO Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Associate Project Manager

  • Feb 2007 - Aug 2008

  San Diego, CA Managed in-house oncology trials from start-ups to close outs. Assisted with study site monitoring and data collection. Queried monitoring visit reports, and wrote initial, interim and final study reports. * Assisted CROs and monitors to conduct and collect data for phase I-IV oncology studies. * Prepared site visit monitoring reports and site visit letters in a timely manner and in accordance with the monitoring plans and applicable SOPs. * Reviewed site documents for accuracy and… Show more Managed in-house oncology trials from start-ups to close outs. Assisted with study site monitoring and data collection. Queried monitoring visit reports, and wrote initial, interim and final study reports. * Assisted CROs and monitors to conduct and collect data for phase I-IV oncology studies. * Prepared site visit monitoring reports and site visit letters in a timely manner and in accordance with the monitoring plans and applicable SOPs. * Reviewed site documents for accuracy and completion, conducted in-house monitoring of study data including SAEs and SUSARs for protocol adherence and on-site quality of data. * Worked with clinical team in the review and creation of study follow-up tools used by all CRAs. * Checked storage, disposition, return or destruction of investigational or clinical supplies, confirming accountability and documentation; provided feedback to director and study manager. * Captured safety related data, adverse events, and follow-up SAEs using Medidata EDC system. * Reviewed quality of data and analyzed results to determine the efficacy of study treatments. * Conducted interim analysis of study data; revised study reports as requested by FDA, and responded to queries received from the FDA. * Assisted data management team to review and finalize study data prior to database lock. Show less



St. Joseph Hospital

• Clinical Research Coordinator/Studies Manager

  • May 2004 - Jan 2007

  Orange County, California Area Managed phase I-III clinical studies. Assisted physician investigators, nurses, and clinical support staff to open clinical trials and enroll patients for oncology studies. * Wrote investigator agreements, prepared contracts and budgets; created CRFs and ICFs; negotiated study fees with sponsors and physician investigators. * Participated in sponsors’ investigator meetings and assisted sponsor CRAs with initiation site visits. * Enrolled patients; obtained informed consents and… Show more Managed phase I-III clinical studies. Assisted physician investigators, nurses, and clinical support staff to open clinical trials and enroll patients for oncology studies. * Wrote investigator agreements, prepared contracts and budgets; created CRFs and ICFs; negotiated study fees with sponsors and physician investigators. * Participated in sponsors’ investigator meetings and assisted sponsor CRAs with initiation site visits. * Enrolled patients; obtained informed consents and followed patients per study protocol. * Prepared regulatory documents, new study proposals, financial disclosure forms, investigator statements (1572), amendments and protocol revisions. * Entered study data using EDC program “Study Manager” and submitted online AE & SAE reports. * Worked with pharmacy and laboratory to ensure sufficient stock and dispense of study materials. * Attended monthly IRB meetings to present new protocols and secured protocol approvals. Show less



Center for Cancer Genetics & Epidemiology, UCI

• Project Manager

  • Aug 2001 - May 2004

  Irvine, CA * Managed a multi-center clinical trial of prostate cancer patients, including a patients’ registry. * Direct reports of research assistants, with supervision to screen and recruit patients, enter data in cancer registry, and enroll patients into a phase II study. * Collaborated with various centers to enroll patients and collect data for a national tumor registry. * Assisted with grant submissions, co-authored study protocols and grant proposals. * Analyzed data and created study… Show more * Managed a multi-center clinical trial of prostate cancer patients, including a patients’ registry. * Direct reports of research assistants, with supervision to screen and recruit patients, enter data in cancer registry, and enroll patients into a phase II study. * Collaborated with various centers to enroll patients and collect data for a national tumor registry. * Assisted with grant submissions, co-authored study protocols and grant proposals. * Analyzed data and created study reports using SAS statistical analysis program. Show less