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Senior Clinical Research Coordinator

Senior Clinical Research Coordinator

ALLIANCE CLINICAL LLCLewisville, TX, US
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Job Description

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES :

  • Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations.
  • Manage, train and support clinical site staff.
  • Review, comprehend and communicate study protocols.
  • Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV).
  • Assist CRC team as requested to facilitate research and business needs.
  • Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP’s.
  • Ensure all data is entered into sponsor’s data portal and all queries are resolved in a timely manner.
  • Work closely with CRO / CRA and IRB.
  • Perform administrative tasks such as ordering supplies and equipment for the study.
  • Manage all required study start up documentation, training and timelines on assigned study protocols.

QUALIFICATION REQUIREMENTS :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPREIENCE :

  • Associate’s degree and / or completion of accredited healthcare certification program, required.
  • Comfortable stepping into a leadership role.
  • 4+ years’ experience in clinical research, required.
  • 4+ years’ experience working as a Clinical Research Coordinator, preferred.
  • Comprehensive knowledge of FDA, GCP & confidentiality.
  • Exceptional attention to detail and organization.
  • Excellent written and communication skills.
  • A proven ability to multi-task in a rapidly changing environment.
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    Clinical Research Coordinator • Lewisville, TX, US

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