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Clinical Trial Study Coordinator

ClinVax Clinical Trial Solutions

Clinical Trial Study Coordinator

Suitland, MD
Full Time
Paid
  • Responsibilities

    Job Description

    The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manager, the Principal Investigator and the Medical Director. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.

     

    ·        Send sites and site representatives new studies available and follow up on their interest

     

    ·        Ensuring the completion and collection of regulatory documents on time

     

    ·        Assisting with data validation and query resolution

     

    ·        Maintain communication record with Clients and Sponsor 

     

    ·        Communicate with Site manager all issues unresolved or needed urgent attention. 

     

    ·        Arrange Site visit between the sponsor representative and the site.

     

    ·        Schedule appointment and coordinate site visits and communicate with site coordinator on every visit 

     

    ·        Maintaining regulatory data integrity.

     

    ·        Functioning as a team player

     

    ·        Coordinates activities for the Institutional Review Board (IRB)

     

    ·        Develop a technique to track study activities.

     

    ·        Schedule patient visit and maintenance of source document

     

    ·        Ensuring implementation and compliance with FDA, ICH-GCP guidelines

     

    ·        Collects data as required by the protocol. Assures timely completion of Case Report Forms.

     

    ·        Maintains study timelines and ISF binders

     

    ·        Maintains effective and ongoing communication with sponsor, research participants and PI during the entire study period.

     

    ·        Perform any task assigned by management team, schedule patient visits and maintenance of source per ICH GCP Guidelines.

    Company Description

    ClinVax is a network of Clinical Research Sites that has assisted a lot of practices nationwide in hitting the ground running in Clinical Trials. ClinVax makes clinical trials very seamless with their array of experienced research staff. ClinVax conducts the entire spectrum of clinical trial activities from, trial identification, through the study start up process to close out activities. The ClinVax module is very affordable and profitable to Investigators and appreciated by patients and the sponsors. Our goal is to reduce the time lag of bringing a compound from bench to bedside.