Clinical Research Associate II

Job ID
1030E
Department
Clinical Trials Administration
Category
Clinical Research
Job Location
US-TN-Memphis

Responsibilities

Responsible for functioning as a site study coordinator by managing sponsor interactions with external collaborating clinical research sites as part of the St. Jude Collaborating Study Sites Office (CSSO): provides St. Jude IRB-approved protocol documents to the sites, reviews site documentation of IRB approval; monitors and tracks contracts and institutional site proposal packets for timeliness and completion; regularly communicates with sites and St. Jude study team to identify and resolve issues or problems; works with principal investigator and study staff to develop study in-service programs and assists in study initiations, monitoring visits and study closure visits for collaborators; reviews informed consent documents for regulatory compliance and facilitates clinical review of informed consent; organizes and schedules clinical study site initiation meetings; oversees site progress, ensures amendments, revisions and continuing reviews are submitted and approved appropriately at each site; maintains essential documents for each collaborating study site, tracks the currency of the information to ensure compliance with regulations; trains each collaborating site in the use of the institutional regulatory document repository and exchange of documents for review and revision using the repository. Customizes assessments of potential sites and works with St. Jude departments to coordinate collaborative activities. Develops and maintains departmental and institutional collaborating sites databases. Manages St. Jude interactions with the study sites before study activation and during study participation. Supports clinical research education efforts pertaining to external collaborating clinical research sites. Facilitates the distribution and completion of required forms to add a collaborating site. Collects and maintains essential regulatory documents to ensure compliance with Good Clinical Practices, International Conference on Harmonization (ICH) guidelines, and federal regulations for investigational products and St. Jude policies. Develops and maintains study specific document and data sharing systems for collaborating sites and St. Jude staff. Maintains CSSO database for transparency and accurate tracking of site status and information.

Minimum Experience

Requires two (2) years of direct experience in clinical biomedical and/or behavioral research.

 

This position also requires experience or background in each of the following:

  • Medical, scientific, and technical terminology used in research protocols and medical records;
  • Utilizing knowledge of regulations and guidelines governing federal/domestic and international clinical trials (ICH-GCP, Belmont Report, HIPPAA, 45 CFR 46, and 21 CFR 50, 56, 312, 812);
  • Utilizing knowledge of institutional policies, IRB policies and procedures, and institutional systems to guide investigations in the conduct of human subject research and ensure compliance;
  • Maintaining mandatory regulatory binders for sites throughout the conduct of a clinical trial containing the most current IRB-approved version of the protocol including amendments, IRB approvals, informed consent form, delegation of authority log, details about laboratory standards, and the qualification of investigators and study staff;
  • Establishing and implementing corrective action plans for deviations from or violations of protocol, missing data, inadequate consent, auditing purposes, and determining if collected data can still be utilized;
  • Developing and implementing training modules at sites;
  • Providing guidance for SJ initiated study start-ups as the regulatory expert;
  • Maintaining complex databases for conducting clinical trials; and
  • Reviewing protocol-related regulatory documents for sites.

Minimum Education

Requires a Bachelor’s or foreign equivalent degree in a related biomedical/behavioral field.

EEO Statement

St. Jude is an Equal Opportunity Employer

 

No Search Firms:

St. Jude Children’s Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

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