Clinical Research:
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.
Approximate Salary Range: $71,800 - 86,200 (Clincal
Programmer III)
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.
Approximate Salary Range: $47,400 - 58,100 (Intermediate
Level)
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 ill 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 0 to 2 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 0 to 2 years' clinical experience
in medical research, nursing, or the pharmaceutical industry. Knowledge
of FDA regulatory requirements is also preferred.
Approximate Salary Range: $53,500 - $65,500 (Level II)
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