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