Clinical Research Associate-RN II

The Clinical Research Associate 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.

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. 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

(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

Ability to think critically, draw insights and connect the dots. Openness to change and adapting to changing times with resilience and flexibility. Learns on the job and applies skills in routine tasks and activities; delivers under supervision and guidance. 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. Skills in communicating complex ideas effectively to diverse audiences and influence others to see different points of view. Is able to apply knowledge/skills within own area to deliver tasks with limited guidance. 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. Focus on setting high targets, following through with actions, and achieving results. Ability to anticipate roadblocks and circumvent challenges. 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. Skills in clinical data management processes/tools to source and compile data with an understanding of potential data needs. 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. Knowledge of study operations and oversight; Ability to plan and manage study activities across sites. 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). Knowledge of regulatory, safety, and/or human subject protection considerations in relation to product development and/or clinical trial conduct. 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.