Clinical Research Associate II

Job 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.

Minimum Education and/or Training:

Bachelor's degree in relevant area required.

• Master's degree preferred.

Minimum Experience:

Minimum Requirement: 2+ years of experience in carrying out research preferably in healthcare settings.

• Experience Exception: Master's degree and some experience preferred.
• 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.

Licensure, Registration and/or Certification Required by Law:

List any licensure or certification REQUIRED and/or PREFERRED by federal or state law to do the job.

• None

Licensure, Registration and/or Certification Required by SJCRH Only:

List any licensure or certification REQUIRED and/or PREFERRED by St. Jude to do the job.

• None

Special Skills, Knowledge and Abilities:

List pertinent skills, knowledge and abilities the person should have to be successful in the job.

• 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.
• 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.
• Spots early indications of underperformance and takes corrective actions. Celebrates successes.
• Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with 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).

Compensation

Explore our exceptional benefits!

Diversity, Equity and Inclusion

St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment.

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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