Clinical Research Associate II - Psychology & Biobehavioral Sciences

St. Jude Children's Research HospitalMemphis, TN
6d

About The Position

As a Clinical Research Associate II in the Department of Psychology and Biobehavioral Sciences, you will support Faculty Investigators examining psychological, behavioral, and cognitive outcomes related to treatment for childhood catastrophic diseases and evaluating interventions addressing these issues. Studies will include, but are not limited to, brain tumor, leukemia, sickle cell disease, and long-term survival outcomes. The ideal candidate will have experience working with newly diagnosed patients, survivors of childhood cancer, and/or those with chronic illness diagnoses. Attention to detail and organizational skills are essential in coordinating data across multiple disciplines and collaborating sites. This role will be research focused and be patient/participant facing.

Requirements

  • Bachelor's degree in relevant area required.
  • Minimum Requirement: 2+ years of experience in carrying out research preferably in healthcare settings.
  • Experience managing cross-functional communication, including liaison between site and study teams.
  • Some experience with documentation and tracking systems/processes.
  • Proven performance in earlier role.
  • Must have a valid driver’s license from the employee’s state of residence and a valid insurance policy on the vehicle which meets the requirements for the state of Tennessee.
  • Effectively relays understanding of diverse perspectives.
  • Can handle communication upwards and downwards as needed.
  • Presents information in a clear, well thought out way and tailored to the audience.
  • Shows support for the new direction even when the details have not been finalized.
  • Uses a data-driven approach to spot early indications of underperformance and takes corrective actions.
  • Celebrates successes.
  • Works with partners in their function to find the best solutions that align with functional priorities.
  • Works effectively to find solutions.
  • Contributes to study management and research procedures by consistently executing on assigned tasks in compliance with GCP guidelines, with minimal supervision
  • Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support).
  • Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.
  • Adapts quickly to changing priorities to perform as needed in his/her role.
  • Remains calm when faced with changes to (and in) his/her work.
  • Supports data management plans with understanding of site/study data sourcing techniques and overall compilation.
  • Independently assists data management tasks/processes in line with study-related data plans.
  • Identifies and resolves data queries and requirements based on knowledge of origin, flow, and management of data through a clinical study.
  • Ensures compliance with SOPs related to data quality within assigned studies.
  • Shows awareness of basic safety, ethical, and HPP considerations, and regulatory requirements in terms of documentation and study conduct.
  • Assists in development of relevant technical, study, and/or regulatory materials to ensure compliance with regulatory, safety, & ethical requirements.

Nice To Haves

  • Master's degree preferred.
  • Master's degree and some experience preferred.
  • Experience working with newly diagnosed patients, survivors of childhood cancer, and/or those with chronic illness diagnoses.

Responsibilities

  • Act as site study coordinator conducting informed consent process as designated, and assisting with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g., CTSRC and IRB) as applicable.
  • Develop, maintain, monitor, and/or share assigned/relevant documentation (e.g., investigator files, case report forms, study data).
  • Perform data abstraction, collection, and entry to support clinical research.
  • Prepare submission for all reportable events (e.g., adverse events, protocol variances, violations).
  • Prepare detailed data reports as required.
  • (As applicable) Provide patient care, education, and management (e.g., routine test conduct; assistance in clinical procedures; medication instruction, monitoring, and documentation; patient care coordination; education on protocol activities).
  • Perform other duties as assigned to meet the goals and objectives of the department and institution.
  • Maintains regular and predictable attendance.
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