Enhancing Skills for the Clinical Research Associate/ Coordinator through a Hands-On Clinical Practicum r C. S. Hurst 1, PhD., RN, CNM and L. Brown-Joseph 2, PhD. Dillard University, Minority Heath and Health Disparities Research Center, New Orleans, LA. 1,, University of Phoenix 2 The Nursing Process (NP) is the theoretical framework (Figure 1) that guided the development of the Clinical Assignments (CA) and creates a cyclic continuum towards closing the gap between the didactic and applied skill. The nursing process consists of five constructs which are sequential and interrelated. The process continues until the goal is achieved. (Ackley 2014; Carpenito-Moyet, 2012). The learner must be able use their assessment skills to develop the correct plan for the person or situation. Its use in the preparation of the CRA clinical assignments is the skill of the learner to outline subjective and objective data in order to use specific guidelines to manage the situation within the set parameters. The five components of the nursing process were operationalized for development of the Clinical Assignments. Operationalization of the Nursing process used during the Clinical Assignments the CRA/CRC does the following related to clinical trials: Assessment – ask questions to enhance an increase understanding regarding the role of the CRO or SRO the clinical trial sites, the Principal Investigator (s) and the site personnel. Diagnosis –identifies, interprets and plans for site selection and utilization for the clinical trial based on assessment data to meet federal, state and site policies. Goal Setting – ensures that the protocol is executed correctly, monitors the plan to assure that the principal investigator adheres to Good Clinical Practice guidelines and the plan is mutual, measurable and with activities occurring within established time frames. Intervention –incorporates standards, guidelines and policies based on ICH-GCP, Declaration of Helsinki, The Belmont Report, etc. To accurately recruit, screen and enroll subjects into the clinical trial. Evaluation –reviews data sets and ensures they are completed and maintained according to required regulatory requirements; participate in audits (internal and external). CONCEPTUAL MODELABSTRACT CONCLUSION AND DISCUSSION There is a need for more experienced Clinical Research Associates and Clinical Research Coordinators in the field of clinical trials research. However, there is limited research identifying hands-on practicum skills sets for the CRA/CRC. The purpose of this article was to discuss the development of Clinical Assignments and their utilization of hands-on practicums for the CRA training program at Dillard University. The discussions of this paper further emphasized the significance of adding Clinical Assignments as a strategy for building skill sets for the learner enroll in the Clinical Research Associate Training program. The process was based on a very practical approach derived from literature survey, involvement and input of community professionals, and a structured approach. Formative and summative evaluation of the CRA training program is conducted at Dillard University annually and every two years. This trended data (qualitative and quantitative) was used to develop hands-on clinical experiences for the CRA learner as well as to make changes within the program and to continue positive relationships with the Clinical Preceptors and the institution. These practices are consistent with the literature and other programs which require clinical experiences (ACRP, 2013). Hands-on clinical practicum's are proven methodologies that assist the Clinical Research Associate (CRA) and the Clinical Research Coordinator (CRC) in applying classroom knowledge to the clinical arena and enhance the learner’s ability to perform skills. Furthermore, Its outcomes measure the level of mastery for the learners’ performance. Technology has afforded researchers the opportunity to study and invent more drugs and devices. This, in turn, has increased the need for more knowledgeable and proficient CRAs and CRCs to manage the increasing demand of the clinical trial industry. This poster highlights the development and utilization of nine Clinical Assignments during Preceptorship rotations using the Nursing Process as a conceptual model, by the Preceptor and the CRA/ CRC to enhance the skill set of the Learner enrolled in the Clinical Research Associate training program. As a result of implementing this hands-on clinical practicum, eighty three percent (83%) of the clinical Preceptors concur that the Clinical Assignments enhance the skill sets of the CRA/CRC learner. It is estimated that in a ten year period, , more than 100,000 job opportunities will exist due to the increased number of clinical trials (CNN.2013). The roles of CRAs are diverse and are absolutely crucial to the success of the clinical trial, however, only two –three years of clinical trials experience is required for such a role (ACRP: CRA, 2013; ACRP:CRC, 2013; Granda, Duane, Munz & Cannon, 2009; Nagel, Gender & Bonner, 2010 and Richmond & O’Mara, 2010). Regulatory agencies continue to increase in complexity and rigor for the initiation, implementation and evaluation of clinical trials. The CRA and CRC must be prepared for the increasing demands of this position. Effective preceptorship programs provide hands-on clinical practicum’s to assist the CRA/ CRC in developing this skill set for the world of work. However, only a few post- baccalaureate training programs, such as Northwestern in Chicago and Duke in North Carolina, offer this teaching- learning strategy in their programs. FIGURE 1. OPERATIONALIZED NURSING PROCESS CONCEPTUAL MODEL STATEMENT OF THE PROBLEM and SIGNIFICANCE REFERENCES RESULTS THEORETICAL FRAMEWORK Formative and Summative results for the development of the Clinical Assignments (CA’s) includes: 1)Program evaluation every 2 years 2)Preceptors meeting every year 3)Student Exit Interviews, and 4)Use of a ten item Likert scale. The scale measures the need for CRAs (1), integration of the NP (2, 3, 4), the CRA learner (5, 6, 7, 8) and The role of the Clinical Preceptor (9, 10). * Data was de-identified and then entered on a coded spreadsheet for analysis. * The response rate was nine out of 11 (81.8%) and each Clinical Preceptor agreed that there was need for CRAs. Nine of 11 (81.8%) were Registered Nurses and all agreed that the Nursing Process was evident in the CAs. About 89% concurred that hands-on clinical practicums experiences were noted in the CAs. Eighty percent rated the role and expectations of the Clinical Preceptor identifiable in the CAs. Ackley, B. J. & Ladwig (2014). Nursing Diagnosis Handbook: An evidence-based guide to planning care. 10 th ed. Elsevier Association of Clinical Research Professionals. CRA Certification Guide. Alexandria, VA: Association of Clinical Research Professionals; Available from: Accessed December Accessed December 2013 Association of Clinical Research Professionals. CRC Certification Guide. Alexandria, VA: Association of Clinical Research Professionals; Available from: Accessed December Accessed December 2013 Carpenito-Moyet (2012). Nursing diagnosis: Application to clinical practice (14 th ed.). Lippincott Williams & Wilkins. Rush, K.L., Adam, M., Gordon, J., Lilly, M., and Janke, R. (2013). Best practices of formal new graduate transition programs: An integrative review. International Journal of Nursing Studies. Volume 50, Issue 3, March 2013, Pages 345–356. onlineVolume 50, Issue 3 RESULTS CRA and CRC ACKNOWLEDGEMENTS Support for this research has come from the National Institutes on Minority Health Disparities at the NIH: P20MD Special thanks to the CRC/CRA students and the participating Preceptors.