clinical research associate ii st jude

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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. Acts as site Study Coordinator for the Division of Endocrinology, supporting the research activities of 3 clinical track faculty physicians, each of whom spends a percentage of time on clinical research. Otherwise, Responsibilities, education, licensure, experience and skills as above. Research projects will include a combination of small clinical trials/intervention studies and observational studies using existing data related to endocrine and/or reproductive consequences of childhood cancer and its treatment.

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.

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 Associate-RN II.

Explore our exceptional  benefits !

Diversity, Equity and Inclusion

St. Jude Children’s Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world—regardless of race, religion or a family’s ability to pay.  Learn more about our history and commitment .

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our  Diversity, Equity and Inclusion Report  to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

St. Jude is an Equal Opportunity Employer

No Search Firms

St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

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Division of Nursing Research

Divisional focus.

The Division of Nursing Research actively contributes to improving patient care and patient care outcomes for all patients and families given care at St. Jude Children’s Research Hospital and its affiliates, and indirectly for children world-wide who have a catastrophic illness. We do this by creating, applying, evaluating and sharing the highest quality clinical care research.

The focus of our research is on effective methods for maximizing the patients’ emotional and physical comfort, identifying mechanisms of underlying biologic and behavioral processes that contribute to suffering, facilitating patient and family coping with illness and treatment, and promoting the practice of positive health habits.

Recently completed and on-going research projects have identified factors that influence treatment choices, including end-of-life decisions made by patients and parents; created strategies to measure fatigue and sleep changes in patients; improved methods for infusing platelets; developed a unique definition of quality of life from the perspective of a child or adolescent; and symptoms that concern parents the most during their child's final week and day of life. Current research is providing a better understanding of symptoms related to cancer and cancer therapy and the trajectory of these symptoms through the disease process into survivorship, facilitating the development of patient profiles for those at risk of symptoms, subsequent diseases, and late effects.

The Division of Nursing Research directs the Evidence-Based Practice Fellowship, an educational and experiential program designed to help clinicians at St. Jude contribute more fully to science and patient care at our hospital.

Nursing Research Honors

Belinda N. Mandrell, PhD, RN,  FAAN , Director, Nursing Research Division

• 2022 – Nurse Executive Leader – Nurse Hero Award
• 2022 – Clinical Care Improvement Award
• 2020 – American Academy of Nursing, Fellow
• 2017 – Association of Pediatric Hematology/Oncology Nursing, Distinguished Researcher Award
• 2011 - American Academy of Sleep Medicine Young Investigator
• 2010 – Association of Pediatric Hematology/Oncology Nursing, Novice Researcher

Jami S. Gattuso, MSN, RN, CPON, Nursing Research Specialist III

• 2017 – Association of Pediatric Hematology/Oncology Nurses, Dr. Casey Hooke Service Award
• 2011 – Association of Pediatric Hematology/Oncology Nurses, Dr. Patricia Greene Leadership Award

Clinical Care Improvement Award

From left: Susan Ogg, MSN, RN; Belinda Mandrell, PhD, RN, FAAN; Michele Pritchard, PhD, RN, PNP; Judy Bosi, BS

The Clinical Care Improvement Award winner for 2022 is the Photobiomodulation for the Prevention and Treatment of Oral Mucositis Team led by Belinda Mandrell, PhD; Michele Pritchard, PhD, RN, PNP; Susan Ogg, MSN, RN; and Judy Bosi, BS. Mandrell, Pritchard, Ogg and Bosi directed a Nursing research team that used photobiomodulation (PBM) therapy to reduce oral mucositis severity and duration for bone marrow transplant patients. PBM applies low-level light to the oral mucosa, which displaces cellular nitric oxide to increase cellular oxygen consumption and decrease oxidative stress. Very few pediatric cancer centers have implemented this process. In a study of 40 patients led by St. Jude Nursing, 93% saw a significant reduction in mucositis, including reduced severity and duration of mucositis and fewer days in the hospital. The study has led to efforts to make this exciting and popular therapy available to more St. Jude patients.

Ongoing Nursing Research Studies

Featured study, prom: prevention of oral mucositis in children and adolescents undergoing hematopoietic cell transplant (hct) using photobiomodulation therapy (pbm).

Oral mucositis is a significant and common toxicity experienced by patients who receive chemotherapy as a preparatory regimen for a hematopoietic cell transplant (HCT). Furthermore, oral mucositis has been reported as the single most debilitating side effect reported by patients undergoing HCT. The incidence of HCT mucositis among adults is estimated to range between 76% and 89%; however, comparisons are difficult due to variability in patient ages, treatments and criteria for scoring oral mucositis.

The use of intra-oral photobiomodulation (PBM) therapy in adult patients after the development of oral mucositis is well documented and now included in the international mucositis guidelines, with limited evidence in pediatrics. This study will build evidence for the incorporation of extra-oral PBM therapy into daily nursing care of children and adolescents undergoing HCT. This intervention has potential in providing evidence for efficacy in the prevention and treatment of oral mucositis, the single most debilitating side effect reported by patients undergoing HCT.

Selected Studies

Assessment of obstructive sleep apnea (OSA) in survivors who receive thoracic radiation and associated factors compared to a community control.

This study explores the prevalence of OSA among adult survivors of childhood cancer treated with thoracic radiation compared to community controls matched on age, sex, race and body mass index. Additionally, the study is exploring therapeutic factors, biomarkers and associations between OSA and cardiac morbidity and brain integrity.

This is a 5-year RO1 funded study through the National Cancer Institute and conducted in collaboration with Epidemiology and Cancer Control, Dr. Kevin Krull. 

Modulated proton therapy for incompletely resected craniopharyngioma and observation after resection

This Nursing Research objective within the RT3CR protocol assesses the sleep quality, daytime sleepiness, circadian rhythm, fatigue, symptom distress and quality of life including association with effects of the tumor and treatment factors including grade of hypothalamic involvement.

Initial findings suggest a high prevalence of narcolepsy associated with higher grade hypothalamic involvement, and both narcolepsy and hypersomnia being associated with obesity.

In collaboration with radiation oncology, neurology and psychology, nursing research is directing an intervention for narcolepsy and hypersomnia with initiation of Modafinil for management of excessive daytime sleepiness.   Click here to view the Modafinil video .

SCDGEN: Sickle Cell Disease (SCD) and the genomic needs of parents and patients

This study will administer surveys to measure the genetic/genomic knowledge, trust in health care provider, and literacy/numeracy ability in parents of children with SCD and adolescents with SCD. We will conduct semi-structured interviews in parents of SCD patients to describe parental attitudes of research involving genomic sequencing, including concerns about participation and expectations from researchers.

This study will add to the deficit of knowledge regarding the attitudes, beliefs, and expectations of parents around clinical research trials involving genomic sequencing.

This is a funded study through NHLBI U01HL133996-04 and in collaboration with Drs. Liza Johnson and Jane Hankins.

ETHPON: Ethical Dilemmas and Moral Distress in Pediatric Oncology Nurses

This quality improvement project will gather information to determine the areas of practice that cause moral and ethical distress among clinical nursing staff. This data will identify barriers in developing potential interventions.

This project is in collaboration with St. Jude nursing and Drs. Arshia Madni, Liza Johnson and Deena Levine

Mechanisms of cancer related symptoms

Nursing Research Staff

• Judy Bosi, BS, CCRP Clinical Research Associate II
• Mary Caples, MA, CCRP Clinical Research Associate III
• Jami S. Gattuso, MSN, RN, CPON Nursing Research Specialist III
• Susan Ogg, MSN, RN, CCRP Nursing Research Specialist III
• Michele Pritchard, PhD, CPNP Advanced Practice Nurse Researcher
• Linda Watts-Parker, BS Administrative Specialist

Focusing on Hope

The St. Jude staff believes that hope is essential to life, and that hope can directly influence the well-being of pediatric patients. Hope can help patients make the best of difficult moments and make sense of having a serious illness. Dreams, wishes and goals point toward today or the future, and hope is what drives those thoughts. Without hope, each day can seem uncertain or even scary. Having hope, for themselves or others, helps children and teens cope with hardships.

The St. Jude staff has done extensive research on this subject. The result is a combination of information and resources that can help you and your child find hopefulness during this hard time.

Division of Nursing Research MS 738, Room R3051 St. Jude Children’s Research Hospital