Clinical Research Assoc II

Clinical Research Assoc II at Nature Careers summary :

The Clinical Research Associate II supports clinical research by managing data collection, abstraction, and case report forms to ensure protocol compliance. They coordinate study activities, assist with protocol submissions and informed consent, and prepare detailed reports for sponsors and regulatory bodies. This role requires strong communication skills, adherence to Good Clinical Practice guidelines, and collaboration with cross-functional teams in a healthcare research environment.

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The Clinical Research Associate II 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 :

Minimum Experience :

Licensure, Registration and / or Certification Required by Law :

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

Special Skills, Knowledge and Abilities :

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $70,720 - $126,880 per year for the role of Clinical Research Assoc II.

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Keywords :

clinical research, data abstraction, case report forms, protocol compliance, informed consent, study coordination, clinical trials, Good Clinical Practice, research documentation, patient care coordination