ACRP Task Force to Establish Clinical Research Associate Competencies

With more than three decades of experience with pharmaceutical and medical organizations, Mary Pat Higley of Newport Beach, California, serves as a self-employed medical utilization review consultant. Mary Pat Higley also stays abreast of developments in her field by maintaining membership with the Association of Clinical Research Professionals (ACRP).

In a recently released statement, the ACRP announced that it has created a task force dedicated to determining the core competencies for entry-level clinical research associates (CRAs). The multi-stakeholder task force was proposed after the ACRP issued a position paper that examined the existing CRA workforce and appealed for competence-based employment practices to replace the established two-year experience obligation for new CRAs.

According to a top official at ACRP, the two-year experience requirement is arbitrary, creates a CRA shortage in the clinical research industry, and fails to advance clinical research quality. The task force will work to determine the necessary competencies for entry-level CRAs and create measures of competence. Subsequently, the task force will promote the adoption of the defined CRA competencies throughout the clinical research establishment.

Improving Medication Accuracy in Senior Care

An experienced clinical researcher, pharmacist, and medication management professional, Mary Pat Higley currently offers her services as an independent medical and data analysis consultant. Mary Pat Higley comes to her current role having served as a clinical pharmacist specialist with Kaiser Permanente, in which role she evaluated prescriptions for elderly patients in skilled nursing and home care.

According to statistics from the U.S. Department of Health and Human Services, approximately 55 percent of elders fail to take their medications as prescribed. This is a serious issue for both the patients and for the home health care workers who are charged with their care. Caregivers can work with elderly patients to improve their compliance, but there are typically many factors that make that challenging. For example, elderly patients who need to take medication on their own may not see well and may need larger print on the label to read the directions for use.

Similarly, an individual with memory problems may need a reminder system, such as a pill box marked with dates and times, while those with arthritis or other dexterity issues may need a bottle that is easier to open. Patients with difficulty swallowing may attempt to crush or split their pills, and it falls to health care workers to inform the patients and their families whether this is safe or not. If not, a different delivery system may be necessary. Medication management techniques will vary by patient, and it is vitally important that caregivers work with each senior individually to determine what would be most helpful to them.