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DOCS - SR Clinical Research Associate Resume Example

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Skylar Simmons
XXXX XXXXXX XXXX XXXX , Frisco , TX 75033
Home: XXXXX XXXXXXXX - XXXXXXXXXXXXXXXXXXXX
Summary
8 years Regional CRA experience - onsite monitoring * 2 years Regional CRA experience - remote monitoring * Extensive EDC experience including Medidata RAVE, INFORM, Trial Master, OC-RDC and IMPACT * Experienced in CTMS, EDC, IVRS including CASCADE and IMPACT HARMONY, ICOTRIAL. * Experience in monitoring Phase I - III in a variety of Therapeutic Areas
Skills

ICH/GCP Guidelines and CFR * Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, Access, OneNote)

Experience
05/2015 to Present
SR. Clinical Research Associate DOCS, Inc
  • Identify, select, initiate, and close-out appropriate investigational sites for clinical studies.
  • Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP Depending upon experience.
  • involved, when required, in other areas of study management.
  • Staff training and contribute to the review of Company systems and procedures as appropriate.
  • Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
  • Report review and approvals.
05/2013 to 05/2015
Sr. Clinical Research Associate Inventiv Health Clinical
  • Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
  • Develops Clinical tools e.g.
  • Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
  • Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, etc.
  • In conjunction with the project manager prepares, organizes and presents at Investigator Meetings.
  • Responsible for the implementation and training of standardized clinical monitoring processes according to corporate standard policies.
  • Responsible for the timely archiving of documents and study materials for the clinical department.
  • Monitors clinical activity timelines and metrics.
  • Provides regular status updates to PM for client reports.
  • Ensures regular project review, using PPD tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met.
  • Perform site facilities inspection Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
  • Monitor and maintain completeness and quality of on-site files Respond to site issues as alerted to and identified by the Clinical Monitoring Associate (CMA) (i.e.
  • non-responsive site, Protocol Deviations concerns, quality issues, and other items that require face to face interaction).
01/2012 to 05/2013
Sr. Clinical Research Associate PRA international Oct
  • Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
  • Develops Clinical tools e.g.
  • Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
  • Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, etc.
  • In conjunction with the project manager prepares, organizes and presents at Investigator Meetings.
  • Responsible for the implementation and training of standardized clinical monitoring processes according to corporate standard policies.
  • Responsible for the timely archiving of documents and study materials for the clinical department.
  • Monitors clinical activity timelines and metrics.
  • Provides regular status updates to PM for client reports.
  • Ensures regular project review, using PPD tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met.
  • Reviews monitoring visit reports and ensures finalization is within contractual timeline.
  • Manages CRF collection and query resolution process Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met.
  • Leads regular conference call meetings with monitors and other clinical team members.
  • May participate in bid defense meetings.
01/2010 to 10/2012
SR Clinical Research Associate COVANCE INC OCT
  • Identify, select, initiate, monitor and closeout investigational sites for clinical studies.
  • Monitor assigned sites to ensure that studies are carried out according to the study protocol, Ockham's SOPs and Work Plans, applicable regulations and the principles of ICH-GCP.
  • Perform source document verification to ensure the integrity, completeness, and accuracy of the data Review the Site Regulatory binder and ensure that all essential documents are filed correctly.
  • Retrieve updated regulatory documents and submits for filing in the sponsor's Trial Master File.
  • Assist site in query resolution to ensure that study timelines are met Ensure adequate documentation and reporting of serious adverse events, protocol deviations and IND safety alerts in accordance with the IRB and Federal regulations.
  • Perform drug accountability to ensure that all drugs sent to the site is properly accounted for and that drug receipts and dispensation records match the physical inventory at the site Train site personnel and where necessary retrain the sites through-out the study period to ensure that quality is maintained.
  • Perform closeout visits to ensure that all relevant documents have been received and filed and that the site is audit-ready.
04/2009 to 10/2010
Clinical Research Associate Joule Inc Luitpold Pharmaceuticals, Inc
  • Perform site visits as required including Site Evaluation Visits (SEV), Site Initiation Visits (SIV), Site Monitoring Visits (SMV) and Closeout Visits (COV) Assist in site selection and qualification, preparing Informed Consent materials, training of site staff, site monitoring, and study document management.
  • Ensure site's compliance to all human subject protection and privacy regulations Review regulatory documents Responsible for all aspects of site management as prescribed in the project plans Maintain study files at the investigational sites and ensure that updated documents are retrieved for filling in the Trial Master File (TMF).
05/2006 to 04/2009
Clinical Research Associate II AAI PHARMA
  • Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies Provides regular clinical status information to team members and project management Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff Communicates common site trends to the CTM and other project team members Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites Ensures Serious Adverse Event (SAE) reporting according to project specifications Responds to requests from investigative sites in a timely fashion Mentors junior level CRAs and serves as a resource for new employees.
Education
Bachelor of Science: Nutrition USMANU DANFODIYO UNIVERSITY -
Project Management Qualified (PMQ Management and Strategy Institute Project):
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Resume Details

This is a real resume for a SR Clinical Research Associate in Frisco, Texas with experience working for such companies as Docs, Inc, Inventiv Health Clinical. This is one of the hundreds of SR Clinical Research Associate resumes available on our site for free. Use these resumes as templates to get help creating the best SR Clinical Research Associate resume.

Previous Companies:

  • DOCS
  • Inc
  • Inventiv Health Clinical

Previous Job Positions:

  • SR Clinical Research Associate
  • Clinical Research Associate
  • Clinical Research Associate II

Schools:

  • USMANU DANFODIYO UNIVERSITY

Level of Education:

  • Bachelor of Science
  • Project Management Qualified (PMQ Management and Strategy Institute Project)

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