Samantha Moulier
Senior Clinical Research Associate at OnPoint Clinical Staffing Services- Claim this Profile
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English Native or bilingual proficiency
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Spanish Native or bilingual proficiency
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Portuguese Elementary proficiency
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Bio
Experience
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OnPoint Clinical Staffing Services
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United States
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Staffing and Recruiting
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1 - 100 Employee
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Senior Clinical Research Associate
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Apr 2022 - Present
On assignment with PPD On assignment with PPD
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PRA Health Sciences
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United States
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Research Services
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700 & Above Employee
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Senior Clinical Research Associate
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Sep 2020 - Apr 2022
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ICON plc
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Ireland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Clinical Research Associate
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Jul 2019 - Sep 2020
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PRA Health Sciences
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United States
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Research Services
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700 & Above Employee
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Clinical Research Associate
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Sep 2017 - Jun 2019
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Labcorp
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United States
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Associate
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Aug 2015 - Sep 2017
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits • Responsible for aspects of registry management as prescribed in the project plans General On-Site Monitoring Responsibilities: • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review • Monitor data for missing or implausible data • Ensure the resources are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according travel policy • Prepare accurate and timely trip reports • Perform CRF review, query generation and resolution against established data review guidelines • Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management • Provide coverage for clinical contact telephone lines, as required • Update, track and maintain study-specific trial management tools/systems • Generate and track drug shipments and supplies, as needed • Track and follow-up on serious adverse events as assigned • Implement study-specific communication plan as assigned • Attend investigators’ meetings, project team meetings and teleconferences, as needed • Perform other duties as assigned by management Show less
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Covance
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United States
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Research Services
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700 & Above Employee
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Investigator Support Coordinator
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Feb 2014 - Aug 2015
Notified investigator sites, sponsors, and affiliates of laboratory results, exclusion flags, and test cancellations as defined in the Statement of Work (SOW) Monitored, tracked and resolved requisition holds and informing the Team Supervisor and the Project Manager of any delays Updated the database with appropriate information and informed personnel of additional testing needs Acted as a liaison for investigator sites and sponsors; communicated investigator site needs when new policies or procedures are discussed. Maintained effective and timely adherence to management communications, meetings, and Standard Operating Procedures (SOP) Assisted and supported management in the implementation of global processes and procedures Tracked and reported metrics in the agreed timelines Documented all service failures, resolved, and escalated to management when appropriate resolution was incomplete Promptly addressed patient safety issues and escalated as needed for resolution Ensured the investigator’s needs are explored prior to implementation of new processes and procedures Show less
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Cardno JFNew
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Indianapolis, Indiana Area
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Project Assistant
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Oct 2011 - Feb 2014
Performed administrative activities such as developing communication documents, forwarding invoices and expense reports for processing, and assisting with light accounting duties and data entry Assisted executive marketing team by coordinating and tracking conferences and meetings, gathering and entering data and continuously updating contacts in Deltek Vision Prepared project folders and reports with necessary materials and provided billable value-added support for technical experts and other project staff in the Midwest region Show less
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Indiana Department of Environmental Management (IDEM)
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Indianapolis, Indiana Area
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Summer Intern
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May 2010 - Aug 2010
Collected water samples from Indiana watersheds and transported specimens to labs Organized analytical water data collected during fieldwork Collected water samples from Indiana watersheds and transported specimens to labs Organized analytical water data collected during fieldwork
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Education
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Indiana University Bloomington
Bachelor of Science (B.S.), Public Affairs -
La Universidad Complutense de Madrid
Study Abroad, Spanish and Immigration