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:
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 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 supervisionApplies 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 Associate I-RN/ Clinical Research Associate II-RN.Explore our exceptional benefits!
St. Jude is an Equal Opportunity Employer
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