Clinical Research

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. The job requires a high school diploma or equivalent, with a minimum of 0 to 2 years' related experience.

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 3-5 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 0 to 2 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 1 to 4 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 0 to 2 years' related experience.