Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
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Professional Summary
Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 5 years of related experience to a challenging new role.
Skills
5+ years of clinical monitoring plan.
Experience working in phases I, II, and III clinical trials.
Experience working in PSSVs, SIVs, IMVs and COVs.
Ability to perform up to 80% of nationwide travel.
Experience monitoring at MD Anderson, UT Southwestern, Mayo Clinic, Dana Farber, MSKC, Mass General Hospital and several other top performing sites.
Excellent communication skills.
Excellent written and verbal skills.
Work History
Senior Clinical Research Associate , 01/2018 to Current Nova Biomedical – Washington, DC,
Performs and documents pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company standard operating procedures, applicable regulatory requirements and defined quality and performance standards.
Ensures site IRB approval is current and all IRB documentation is in order.
Maintains site monitoring schedule and serve as the principal point of contact for investigational sites.
Documents and reports on clinical study progress (i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members).
Ensures patient safety is maintained and informed consent procedures are carried out.
Provides training and update investigative site team of any changes in study conduct and documentation requirements.
Ensures continued acceptability of the investigator, clinical site team and facility.
Reviews clinical data, source documentation, CRF, and investigative site regulatory files.
Works closely with data management and site to resolve discrepancies
Ensure investigational product accountability accuracy and oversee investigational product inventory.
Liaises with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies.
Meets with clinical study sponsor representatives as requested.
Ensures resolution of issues with investigative sites.
Attends meetings as assigned and report on actions.
Participates in educational activities and programs.
Maintains strictest confidentiality.
Works closely and effectively with all other department personnel to ensure appropriate communication and study conduct.
Assists other staff as requested and perform other related work as needed.
Functions as a mentor for team members.
Maintains awareness of current developments in therapeutic area relative to assigned projects.
Clinical Research Associate II, 07/2016 to 01/2018 Danaher – Redwood City, CA,
Completed Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and completes reports to quality standards within company specified timelines.
Responsible for performing study activities regarding the implementation and monitoring of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs.
Monitored recruitment and data quality while on site and remotely through EDC systems/communication with sites.
Performed on-site drug accountability and reconciliation, and verifies drug storage meets protocol and SOP requirements.
Performed ongoing reviews of Investigator’s Trial File to assure quality of the documentation files, completion and compliance with company SOPs, GCP and ICH Guidelines while on site.
Completed follow up letters from all visit types according to SOPs and completes reports to quality standards within company specified timelines.
Responsible to ensure that the mandatory trial entries are made in all requisite study systems including clinical trial management systems, IVRS, TMF, etc.
Closed collaboration with other members within Clinical Trial Management (CTM) and with various vendor team members to ensure synergy and coordinated response to study issues.
Ensured compliance with the application and communication of all sponsor policies, procedures and fundamentals.
Acted as primary liaison for assigned study sites while on-site to convey project information, answer questions and address study issues in accordance with the monitoring plan.
Assisted the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation.
Prepared, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
Clinical Research Associate I, 08/2015 to 07/2016 Covance – Denver, PA,
Document data on specimen collection, processing and storage.
Assessed adherence to procedures, practices and all applicable regulatory requirements.
Resolved issues with investigative sites utilizing knowledge, expertise and problem-solving techniques.
Provided clinicians with information on how to properly conduct trials.
Obtained site approvals and gathered all documentation prior to beginning studies to meet rigorous standards.
Provided training and updated teammates of any changes in study procedures and documentation requirements.
Supported development and delivery of department training.
Met with clinical study sponsor representatives to discuss study details.
Created and maintained database and records filing system to document data on specimen collection, processing and storage.
Reported general issues directly to management promptly for efficient problem-solving and resolutions.
Clinical Research Coordinator, 01/2013 to 08/2015 Central Maine Medical Center – Auburn, ME,
Lead recruitment efforts of clinical trial subjects and ensured fruition of enrollment goals.
Reviewed and developed familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Consented several subjects prior to participation in clinical trial .
Performed several study related task including but not limited to the collection of safety labs, ECG and Vital signs .
Resolved queries and issues that were identified by Clinical Research Associates .
Maintained effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Education
Bachelor of Arts: Business Administration, Expected in Texas College of Cosmetology - Abilene, TX GPA:
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