Clinical Research Associate I-RN Clinical Research Associate II-RN

CRA I

Job Responsibilities:

• Perform data abstraction collection and entry to support clinical research.

• Assist with submission for all reportable events (e.g. adverse events protocol variations).

• Maintain/enter data as required for case report forms.

• Ensure compliance with prescribed interventions and evaluations of the assigned protocol(s).

• Provide data to the collaborating research organization (CRO) or study sponsor and prepare data reports as directed.

• (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:

• Bachelors degree in Nursing required.

Minimum Experience:

• Minimum Requirement: Prior industry experience preferred.

Licensure Registration and/or Certification Required by Law:

• (LC: RN-TN) Must possess a current Tennessee State Board of Nursing license if primary residence is Tennessee or a Nurse Licensure Non-Compact state.

• (LC: RN-MISS RN-ARK or RN-KY) Must possess a current State Board of Nursing license in the state of primary residence if the state is a Nurse Licensure Compact state.

Licensure Registration and/or Certification Required by SJCRH Only:

• None

Special Skills Knowledge and Abilities:

• Seeks clarifications to understand what is being said.

• Is able to clearly summarize information learnt to confirm understanding.

• Writes in a clear and concise manner and speaks succinctly and confidently.

• 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 clinical study and site management by performing basic tasks (operations/study management) under supervision.

• Exhibits understanding of key concepts related to clinical studies (e.g. baseline determinants of new study selection process risk assessments).

• Applies basic understanding of clinical data management processes tools & concepts to support data sourcing and compilation for assigned studies/areas with guidance.

• Addresses data queries and requirements based on knowledge of origin flow and management of data through a clinical study.

• Plans in advance organizes own work and executes high-quality work on time. Shows initiative to take on more responsibilities/work.

• Embraces goals and demonstrates a sense of urgency in achieving them.

• Holds self to high standards and keeps pushing to meet them.

• 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.

CRA 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:

• Bachelors degree in Nursing required.
• Masters degree preferred.

Minimum Experience:

• Minimum Requirement: 2 years of experience in carrying out research preferably in healthcare settings. (For CRA II)
• Experience Exception: Masters 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:

• (LC: RN-TN) Must possess a current Tennessee State Board of Nursing license if primary residence is Tennessee or a Nurse Licensure Non-Compact state.
• (LC: RN-MISS RN-ARK or RN-KY) Must possess a current State Board of Nursing license in the state of primary residence if the state is a Nurse Licensure Compact state.

Special Skills Knowledge and Abilities:

• 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

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