Clinical Research Coordinator (CRC) Advanced

Provides an overview of project management principles, how the principles can be applied to managing clinical trials, and how using project management methodologies can increase trial efficiency by minimizing omissions and redundant activities. This module also discusses tools that CRCs can use to help manage a clinical trial.

Recommended Use: Required
ID (Language): 17864 (English)
Author(s): Jessica Derr, BA, CCRC, CRCP - Texas Health Resources; Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Describes the CRC’s role in preventing and identifying misconduct and noncompliance in clinical research, and provides strategies for investigating issues, performing a root cause analysis, and creating a corrective action plan.

Recommended Use: Required
ID (Language): 17865 (English)
Author(s): Nancy Wintering, LCSW, CCRP - Thomas Jefferson University

Presents practical strategies for experienced CRCs to orient new CRCs, including development of standardized orientation programs that cover essential domains. Discusses continued training and professional development for experienced CRCs, such as mentoring and self-directed learning.

Recommended Use: Required
ID (Language): 17866 (English)
Author(s): R. Jennifer Cavalieri, BSN, RN, CCRC - University of Nebraska Medical Center; Mark E. Rupp, MD - University of Nebraska Medical Center

Provides an overview of budget formulation and cost identification, discusses subject remuneration and reimbursement, reviews complex billing issues (including Medicare), identifies how to avoid fraud and abuse in billing, and concludes with the importance of budget reconciliation.

Recommended Use: Required
ID (Language): 17867 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Identifies regulatory considerations associated with subject recruitment. Discusses the steps in developing a subject recruitment plan, strategies for approaching subjects, barriers to study participation, and challenges and strategies for subject retention.

Recommended Use: Required
ID (Language): 17868 (English)
Author(s): R. Jennifer Cavalieri, BSN, RN, CCRC - University of Nebraska Medical Center; Mark E. Rupp, MD - University of Nebraska Medical Center

Describes the role of statistics and informatics in research, including an overview of different study designs and the application of biostatistics to determine sample size. The module also discusses clinical data management and the significance of data quality.

Recommended Use: Required
ID (Language): 17869 (English)
Author(s): Farida Dabouz, PhD, CCRP

Provides a brief overview of several specialty areas and regulations that CRCs may encounter in the conduct of clinical research with investigational products, including: electronic records, systems, and signatures; research with biologics; good manufacturing practice (GMP); and shipping and receiving hazardous and dangerous goods.

Recommended Use: Required
ID (Language): 17870 (English)
Author(s): Nancy Wintering, LCSW, CCRP - Thomas Jefferson University