Experience

Synteract

• United States
• Biotechnology Research
• 100 - 200 Employee

• Senior Clinical Research Associate

  • Apr 2022 - Present



DOCS

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Research Associate

  • Mar 2021 - Apr 2022



Sarah Cannon

• United States
• Research Services
• 300 - 400 Employee

• Senior Clinical Research Associate

  • Apr 2018 - Mar 2021

  Assist in the Investigator selection and qualification process and development of patient recruitment strategies. Perform and document study site evaluations, initiations, interim monitoring and study closeout visits in accordance with GCP, study specific requirements, clinical monitoring plans, company standard operating procedures, applicable regulatory requirements and defined quality and performance standards. Ensure study safety is maintained and informed consent procedures are complete. Provide training and update investigative site team of any changes in study conduct and documentation requirements. Work closely and effectively with all other department colleagues to ensure appropriate communication and study conduct. Function as a mentor for junior team members. Maintain awareness of current developments in therapeutic area relative to assigned projects. Throughout the conduct of the clinical trial assess adherence to Sarah Cannon SOPs, GCP and all applicable regulatory requirements.



DOCS

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contractor - Regional Clinical Research Associate

  • Jun 2016 - Apr 2018

  Assume a range of monitoring responsibilities including coordination of study start up activities, including site selection and initiation of clinical sites; provide training as required per protocol, and GCP guidelines; providing ongoing support to internal team and study sites. Maintain the highest standards with regards to clinical trials. Overseeing progress and ensure the trial is conducted, recorded, and reported in accordance with the protocol and GCP guidelines. Verify compliance of standards of GCP and regulatory requirements. Ensure the integrity of data is maintained throughout all aspects of data capture, analysis and reporting.



Real Staffing

• United Kingdom
• Staffing and Recruiting
• 500 - 600 Employee

• Contractor - Clinical Research Associate

  • May 2016 - May 2016

  Contract Sr. CRA on assignment with PPD. Contract Sr. CRA on assignment with PPD.



Chiltern

• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Clinical Research Associate

  • Aug 2015 - Apr 2016



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Research Associate

  • Dec 2014 - Jul 2015



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Senior Clinical Research Associate

  • Jun 2010 - Dec 2014

  Implemented and monitored multiple complex clinical trials to ensure sponsor and investigator obligations were met and were compliant with applicable local regulatory requirements and ICH guidelines. Performed pre-study site selection, including site facility evaluation and staff qualification visits. Executed ongoing clinical site monitoring visits, review data to ensure GCP and Protocol compliance, and ensure accuracy of data collected with respects to source document verification and Investigational Product (IP) accountability, SAE reporting and reconciliation of SAE reports; query resolution and ongoing assurance of adequate personnel and facilities.



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sr. CRA III (Regional)

  • Apr 2008 - Jun 2010



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. CRA (Regional)

  • Jul 2006 - Apr 2008