Clinical Research Associate -RN​/Clinical Research Associate II-RN

Location

Memphis, TN

Category

Clinical Research

Department

Cancer Center - Clinical Research

Shift

Weekday Day

Position Type

Full Time

Scheduled Weekly Hours

40

JR6352

The Clinical Research Associate I OR II-RN is responsible for performing data abstraction, collection, and entry to support clinical research. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data and reports to the collaborating research organization or study sponsor.

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)  /p

• 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 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:

• Bachelor's degree in Nursing required.
• Master's degree preferred.

Minimum Experience:

• Minimum Requirement: 2+ years of experience in carrying out research preferably in healthcare settings. (For CRA II)
• Experience Exception:
  Master's degree and some experience preferred.
• Experience…