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Clinical Research Associate

A clinical research associate (CRA), also commonly referred to as a “fact checker” is responsible for coordinating and reviewing reference backup materials necessary for client submission. The CRA’s primary purpose is to provide support for claims and to correct questioned ones, as deemed appropriate. These queries are then brought to the attention of the copywriter and the account person until a satisfactory solution is reached. Generally, two CRAs are assigned to each account with one serving in a primary role and the other in a backup capacity. This individual must have technical knowledge of editorial and proofreading techniques as well as an understanding of medical copy editing in a marketing environment.

Functions and Responsibilities

.  Develops and maintains individual accounts’ references and organizes all materials used as claim support in marketing materials.

. Reviews all manuscripts and determines areas requiring substantiation.

. Reviews the most recent sales aids (either referenced by the copywriter or “picked up" from an old job) and verifies any claims with their respective references.

. Prepares submission-ready packages of reference materials for client, med-reg and/or FDA.

. Participates in client regulatory review meetings via conference calls, as necessary to support substantiated claims.

,  Attends all relevant account meetings including, but not limited to: job start meetings, status meetings, client conference calls and internal regroups.

. Develops and maintains agency central filing system. Provides reference citation information to copywriters. Proofreads all materials during reviews.

. Researches specific topics that are related to the various drugs to glean a better understanding of clinical indications.

. When time permits, reads through articles/data and highlights important information for the copywriters to use while working on manuscripts.

.  Proactively researches current information relating to breakthroughs, newly- published articles regarding the drug and/or its competitors, as well as FDA approvals and indications of various drugs and/or its competitors as to efficacies in the medical and marketing environments.


Personal Characteristics/Attributes

The clinical research associate must have the ability to analyze and solve practical problems. It is essential that this individual communicate effectively with internal staff as well as the client. Viewing problems from a broad perspective is critical to success in this role. The CRA needs to exhibit creative and innovative thinking, flexibility and proficiency at multi-tasking. Striving for balance in a role that can have lulls as well as rigorous deadlines where significant overtime could be required is a valued trait for this position.















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