This area involves the final stage before the release of a drug to the market. All human drugs undergo rigorous testing on human subjects to ensure that the drugs are both effective and safe to use. These companies rely on volunteers or paid subjects to test the drugs that have been manufactured and need to fulfill the requirements of the FDA. Their training varies from basic science to nursing to pharmacy to business. There are a number of these in the Kansas City metropolitan area and some of the state, including Quintiles Transnational (Overland Park) and PRA International (Lenexa).

Clinical Research Administrator

A clinical research administrator is responsible for clinical data entry and validation to ensure legibility, completeness, and consistency of data. He or she assists users with requests for clinical documents and is responsible for working with physicians and/or their staff to clarify any questionable information. He or she may be responsible for auditing internal patient files and studies and for assisting with the development and evaluation of clinical record documents. A clinical research administrator, at the entry level, typically develops internal record keeping system(s), including maintaining and auditing data and providing status and activity reports as required. A high school diploma or equivalent, and a minimum of zero to two years related experience required.

Clinical Coordinator

A clinical coordinator must be familiar with the scientific/investigative process. Expertise may be limited to a specific functional area. A clinical coordinator must have good communications skills, both written and oral. He or she must also have project team experience and a familiarity with standard computer applications. Responsibilities include coordinating the clinical development plan as outlined by the company or clinical department, defining objectives, strategy and studies. The clinical coordinator must provide support for planning, including detailed effort estimates, scheduling and critical path analysis. He or she must monitor clinical activities to identify issues, variances and conflicts, and analyze and recommend solutions. The clinical coordinator is responsible for project staffing requirements and tracking drug supply to outside vendors, as well as providing ongoing, objective updates on progress and problems with projects, tracking and following up on action items. The position requires a bachelor of science or a bachelor of arts degree in health science, information technology, or business and three to five years of experience in the health care industry.

Clinical Programmer

A beginning clinical programmer is responsible for coordinating and monitoring the flow of clinical data into the computer database. He or she analyzes and evaluates clinical data, recognizes inconsistencies and initiates the resolution of data problems. He or she implements data management plans designed to meet project and protocol deadlines, and consults in the design and development of clinical trials, protocols and case report forms. A clinical programmer also acts as liaison between clinical management and subcommittees and project teams on an as-needed basis. An entry-level position as a clinical programmer requires a bachelor of science degree or equivalent, although a master of science degree is often preferred. A minimum of zero to two years experience in pharmaceutical programming in the clinical research area is also required.

Biostatistician

A biostatistician works with others to define and perform analyses of databases for publications, presentations to investigator meetings, and for meetings of professional societies. A position as a biostatistician requires at least a master’s degree in biostatistics and one to four years related experience.

Clinical Data Specialist

A clinical data specialist is responsible for collaborating with various departments on the design, documentation, testing and implementation of clinical data studies. He or she develops systems for organizing data to analyze, identify and report trends. A clinical data specialist also analyzes the interrelationships data and defines logical aspects of data sets. A starting position as a clinical data specialist requires a bachelor of science degree or equivalent and a minimum of zero to two years related experience.

Drug Experience Coordinator

The major responsibility of a drug experience coordinator is to handle the drug experience activities for marketed products. The candidate will also provide drug information on the products. He or she will oversee day-to-day processing of adverse event information for marketed products and will coordinate the receipt, classification, investigation and processing of adverse experience reports. A position as a drug experience coordinator requires a Pharm.D. or equivalent clinical training and zero to two years related experience.

Clinical Research Associate

A clinical research associate is responsible for the design, planning, implementation and overall direction of clinical research projects. He or she evaluates and analyzes clinical data and coordinates activities of associates to ensure compliance with protocol and overall clinical objectives. He or she may also travel to field sites to supervise and coordinate clinical studies. An entry-level clinical research associate position typically requires a bachelor of science, a registered nurse degree or equivalent and a minimum of zero to two years clinical experience in medical research, nursing or the pharmaceutical industry. Knowledge of FDA regulatory requirements is also preferred.