Home-Based Clinical Research Associate - CRA

Company: Sarah Cannon Research Institute ( Learn More )

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General Information
US-CO-Nashville, Denver and cities in FL
N/A
Not Specified
Full-Time
At least 3 year(s)
Not Specified
False
False
Job Description

Home-Based Clinical Research Associate - CRA

  

Sarah Cannon Research Institute (SCRI) has an immediate need for a full-time Home-Based Clinical Research Associate.  The Clinical Research Associate performs routine site monitoring visits, participate in site selection, site initiation and study closure activities to ensure that the conduct of the oncology clinical trial is being conducted according to the approved protocol, amendments, company SOPs, and all regulations and guidelines.

Responsibilities:

  • Assists in the development of oncology patient recruitment strategy
  • Perform pre-study research site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits
  • Maintains site monitoring schedule
  • Document and report on clinical oncology research study progress
  • Assists in the Investigator selection and qualification process
  • Ensures oncology patients safety is maintained and informed consent procedures are carried out
  • Review clinical oncology study data, source documentation, CRF, and investigative site regulatory files
  • Assists in planning and preparation of Investigator Meetings
  • Throughout the conduct of the conduct of the clinical trial assesses adherence to SCRI SOPS,Good Clinical Practice (GCP) and ICH regulations and guidelines
  • Attendance at Investigator Meetings
  • Ensure IRB certification is current and all IRB documentation is in order
  • Update investigative site team of any changes in study conduct and documentation requirements
  • Ensure continued acceptability of the investigator, clinical site research team and facility
  • Work closely with data management and research site to resolve discrepancies
  • Ensure investigational product accountability accuracy and oversee investigational product inventory
  • Meets with clinical research study sponsor representatives as requested
  • Attends meetings as assigned and reports on actions
  • Participates in educational activities and programs
  • Maintains strictest confidentiality
  • Works closely and effectively with all other department personnel
  • Assists other staff as requested and performs other related work as needed
  • Functions as a mentor for junior team research members
  • Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement"

    •  

    Qualifications:

  • Bachelor’s Degree in nursing, life sciences, or related field required
  • Minimum of 3 years’ experience working as a home-based clinical research associate required
  • Minimum of 3 years’ direct monitoring experience required
  • Experience working in PhaseI and Phase II oncology studies required

    • About Us

    Sarah Cannon Research Institute (SCRI) is a global strategic research organization focusing on advancing therapies and accelerating drug development. It is one of the largest clinical research programs in the world, conducting community-based clinical trials in oncology, cardiology, gastroenterology and other therapeutic areas through affiliations with a network of nearly 700 physicians in the United States and United Kingdom. Additionally, SCRI offers management, regulatory and other research support services to drug development sponsors and strategic investigator sites across the country.

    Through the careful work of multiple investigator sites and hundreds of principal investigators across the country, SCRI is able to offer clinical trials that have benefited thousands of individual patients and in some cases, changed the standard of care for all.

    We are an Equal Opportunity Employer – Apply Today!

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