Lead Clinical Research Coordinator, Oncology Research

Atlantic Health System

Mentor
Leah M. Zitelli, BSN, RN, OCN

Lead Clinical Research Nurse/ Breast Coordinator
Carol G. Simon Cancer Center
Morristown Medical Center
Atlantic Health System

Mentor
Rosemary Stefiniw, R.N., M.S., C.C.R.C.
Director of Atlantic Research Center
Atlantic Health System

703 Main Street
Paterson, NJ 07503
Tel: 973.754.2000

 

Apply knowledge of the role of the clinical research coordinator profession 

 

Understand each role of clinical research team members at AHS by the end of this semester.

 

Apply comprehensive professional knowledge of best practices in education and training clinical research team members 

 

Synthesize comprehensive knowledge of practices in the clinical research team. 

 

Advance the quality in clinical research team training at AHS at the end of this semester. 

 

Analyze the learning needs of CRCs to produce an E&T (Education and training) plan at AHS and SJHMC.

 

Develop a guide map to build a clinical research team and E&T (Education and training) plan integrated as an internship approach to improve research outcomes and satisfaction. 

 

This project would align with the need not only for the current research program in AHS but also strive to develop an improved clinical research program in SJH.

I will demonstrate comprehensive professional knowledge of best practices in education and training clinical research team members and synthesize comprehensive knowledge of practices in the clinical research team. 

I will also demonstrate comprehensive clinical research knowledge to champion quality in clinical research team training at AHS at the end of this semester. These analyze the learning needs of CRCs to produce an E&T (Education and training) plan at AHS and SJHMC.

 

 

These learning objectives encompass I can develop a guide map to build a clinical research team and E&T (Education and training) plan integrated with an internship approach to improve research outcomes and satisfaction. This project would align with the need not only for the current research program in AHS but also striving to develop a new clinical research program in SJH. I hope that I will provide a guild map for developing the clinical research team and E&T plan at the end of the semester.

 

As a clinical research student in nursing, I need to understand their responsibilities, have self-assurance, persevere through challenges, and work together effectively. My strengths and areas for development may positively and negatively influence the relationships with and between the interdisciplinary team at ARC. 

Clarity regarding my role is essential to the orientation process because it enables the CRC to better understand its position on the inter-professional team. I need to have a clear understanding of the tasks they have and how those obligations fit into the bigger vision. Trust and confidence are also essential components of a CRC's orientation since I can trust Molly and Leah, with whom they are working, and have confidence in their capabilities. I hope to make a meaningful contribution to the team. For instance, I'm detail-oriented and organized, which can assist in maintaining the team's forward momentum and sense of order. I can draw lessons from their past errors and use those experiences to improve their performance, and I can help improve the team's orientation process. However, I may waste the team's time if it can successfully exploit its strengths or possibilities for advancement that make it less productive overall. 

In conclusion, it is essential for clinical research coordinators (CRC) to have a clear understanding of their roles, to exude trust and confidence, to be able to triumph over challenges, and to be able to exercise collaborative leadership.

As my stress level was rising tremendously due to school and work, it was a very refreshing and exciting event that I could see the world of CRC in the pharmaceutical world. I was re-educated about the role of CRC by LaTonya and Dawn. While LaTonya went over the various roles of professionals working in the research field to manage the progress of clinical trials, Dawn explained how pharmaceutical industries engage patients/participants. The role of the CRCs is important in ensuring that trials are conducted according to protocol and in compliance with ethical and legal standards. The coordinator ensures that the trial is conducted ethically and complies with all protocols and regulations, which includes ensuring that informed consent is obtained from all trial participants, that the rights of participants are protected, and that the protocol conducts the research. Dawn explained that the company also works to educate and support trial participants. The coordinator is responsible for the day-to-day management of the clinical trial, which includes working with the research team to develop the protocol, ensure that the trial is conducted according to plan, and monitor the trial's progress. CRCs work with the trial's sponsors to ensure that they are kept up to date on the progress of trials. The coordinator also plays a pivotal role in educating and supporting trial participants, including providing information about the trial to potential participants, helping participants understand the procedures and risks involved, and answering any questions they may have. The coordinator also helps participants to stay motivated and compliant with the trial protocol. The CRC's role in both industries is important in ensuring that clinical trials are conducted safely, ethically, and in compliance with all applicable protocols, regulations, and laws. The coordinator also plays a vital role in supporting and educating trial participants. Clinical research coordinators have different responsibilities depending on the industry field. Clinical research coordinators may need help carrying out their daily responsibilities due to differences between pharmaceutical companies and hospital sites' priorities, laws, and practices. Clinical research coordinators may be increasingly involved in patient care at hospitals. They oversee making appointments, gathering medical information, and keeping track of patients during clinical trials. They also oversee counseling patients and educating them about the trial procedure. Clinical research coordinators at hospital sites could also be subject to additional rules and guidelines than those at pharmaceutical firms. They organize research projects, gather and sort data, and perform statistical analysis. Writing research papers and presenting findings to the research team may also fall under their purview. Clinical research coordinators employed by pharmaceutical firms might interact with patients less frequently than those employed by hospitals. The decision to work for either sort of organization has benefits and drawbacks. Clinical research coordinators at pharmaceutical corporations could be more concerned with gathering and analyzing data where there is a specific role that makes recommendations of trial direction based on analyzed data by medical data scientists, which most hospital sectors do not.

Additionally, during this course, I have acquired practical skills and knowledge that will benefit my future career as a clinical research coordinator. When it comes to clinical research, we have learned that it is important to ensure that the research is conducted ethically and responsibly, which is deeply affected by the process of orientation, education, and training. The structured orientation provides the clinical research coordinator to be directly involved in preparing the research assistants and nonclinical research personnel for their research duties. This way, there will be no misunderstanding about responsibilities or expectations regarding quality assurance, data collection procedures, and proper handling of sensitive information. This course and the project experience in real clinical research are beneficial and provide an opportunity to learn about clinical research education and training and gain first-hand experience working with other clinical research coordinators. The clinical research coordinator is an integral research team member, and their learning about providing care to that population is critical as they move into their future role as a coordinator. 

Many methods can be utilized to assess the outcomes of the orientation program, including surveys, interviews, focus groups, and observations. Surveys are a common evaluation method used to assess various outcomes, including knowledge, skills, satisfaction, and program implementation. For this evaluation, a survey could be developed that assesses coordinators' knowledge of the clinical research process and their ability to perform their duties (Musshafen et al., 2021). Interviews and focus groups are other common evaluation methods and can be used to explore coordinators' experiences with the orientation program. Interviews and focus groups can provide insights into CRCs' perceptions of the program, what they found to be most helpful, and any areas that need improvement. Observations can also be used to assess the outcomes of the orientation program in which method with a checklist is used in most orientation programs. Observers can watch coordinators as they work and take note of their behavior, interactions with patients, and use of technology. Observations can provide valuable information about coordinators' knowledge and skills and their ability to apply what they have learned (Lalithabai et al., 2021). The specific methods used to assess the outcomes of the orientation program will depend on the resources and time available. However, a combination of methods is often utilized to evaluate better the orientation program (Rasool et al., 2015). It is important to note that the evaluation process does not end with the report. If necessary, the evaluation findings should be used to make changes to the program. The evaluation should be viewed as an ongoing process to improve the program over time.