Clinical Research Project Manager
Resume:
THERAPEUTIC/INDICATION EXPERTISE: Oncology (Leukamia, Head & Neck, Liver, brain tumor, Breast and Pancreatic), Psychiatry (Mood, depression and Bipolar Disorders), Neurology (Acute Pain and Epilepsy), General Medicine (Acne and Glucoma) Medical Device, Ophthalmology ( Dry eye, and conjunctivitis)
CLINICAL TRIAL EXPERIENCE/SYSTEMS – Medi-Data Rave, DataLab, Inform, Siebel, Impact Harmony, IVRS/IWRS, Endpoint,
EDUCATION:
Stephen F Austin State University – Nacogdoches, TX
Masters in Science
EMPLOYMENT HISTORY :
Date of Employment:
Name of Employer:
May 2014 - Present
Precision Oncology
Job Title:
Senior CRA
Key Responsibilities:
Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Issue/manage site Queries in EDC for closure.
Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalated quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Date of Employment:
June 2012 – May 2014
Name of Employer:
Worldwide Clinical Trials
Job Title:
Clinical Research Associate II
Key Responsibilities:
Performed feasibility studies for potential sites as requested conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
Compiled and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g IRB/IEC study approval, informed consent, etc.)
Coordinated study material (e.g CRFs, manuals) shipment and receipt by study site.
Document site visit findings via written reports
Provided input into the design of protocols, CRFs and monitoring plan as requested
Assessed, monitor, and train study site staff on protocol adherence as required
Provided applicable updates for site related documentation for filling in the Trial Master File (TMF)
Assisted sites in data query resolution
Maintained regular communication with sites
Completed final site close out visit and report
Date of Employment:
November 2009 – June 2012
Name of Employer:
Bellicum pharmaceuticals
Job Title:
Clinical Research Associate
Key Responsibilities:
Participated in the planning of study implementation with department managers. Participated in protocol development and case-report form design as assigned.
Reviewed protocols and became familiar with details of single and multi-center research studies. Communicated with study personnel to confirm and clarify protocol guidelines.
Assisted in vendor identification, assessment and management.
Traveled to study sites to monitor and co-monitor progress of studies. Collected, reviewed and corrected case report forms in accordance with study specific timelines.
Monitored progress of patient enrollments and other benchmarks to assess ongoing progress and adherence to study protocol by the investigator sites.
Prepared program and study status reports for CRM and therapeutic team.
Maintained study files by reviewing and archiving critical documents such as IRB approvals, FDA 1572 and adverse experience forms as well as all study related correspondence.
Monitored study master file at clinical research organization
Date of Employment:
May 2008 - November 2009
Name of Employer:
Introgen Therapeutics Inc
Job Title:
Clinical Trial Assistant
Key Responsibilities:
Assisted in the development and implementation of the annual QA-GCP/PV audit plan using a risk-based approach.
Developed an audit agenda and communications (e.g., pre-audit document requests) with auditee’s for each assigned audit project.
Conducted audits and ensure timelines for completion of audits are met.
Complied with all applicable SOPs, policies, global regulations, etc.
Escalated audit issues/concerns to QA management.
Produced audit reports and corrective action tables.
Developed status reports with key metrics on audit progress.
Issued applicable audit certificates.
Maintained accurate and timely documentation of assigned QA activities.
Assisted clinical team to manage the process for site Clinical Trial Agreement
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