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 staff 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 the ability to understand and interpret medical/scientific information and a curiosity about and drive to learn the business of advertising.
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 and verifies any claims with their respective references.
- Prepares submission-ready packages of reference materials for client, med-reg and/or FDA.
- Works within cloud-based software systems to record and submit submission packages.
- 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 digital reference filing system.
- Provides reference citation information to copywriters.
- 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 that could be used in promotion.
- 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.
- 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.
Since our beginning in 1981, AbelsonTaylor has remained singularly focused on brands that help people live healthier lives. We don’t design for sneakers, or beer, or cars. We are 100% focused on and passionate about health and wellness.
The goal is simple; create an environment where very different people with unique skill sets and diverse personalities work together toward a common goal. When the products you sell are ideas, strategies and relationships, your most important assets are your people, your people, and your people.
And we are Passionate about our People. It says so right in our Values, along with Cherish Creativity, Fearlessly Independent, Always Curious, and Teamwork. All of which support our Vision: Be the most sought after Health and Wellness agency
So how do we get there? AT has Core Competencies which define expectations of all employees:
– Conveys one’s thoughts written or verbally in an articulate, confident, and compelling manner that positively influences others to take action
Teamwork and Collaboration
– The ability to relate to others, work cooperatively and collaboratively while acting in ways that support the success of the overall team, and drawing out the positive potential of differences
– Takes personal responsibility for meeting commitments and ensures that results are achieved including that expectations are clear, priorities established, focus maintained and tough decisions addressed
– The orientation to keep in close touch with the needs and perspective of internal and external customers and the deep awareness of how these actions serve them while supporting the strategic Vison and Values
– The ongoing effort to learn from ones’ own experience and from others - not only to improve oneself but to do what is necessary to help the organization make significant positive changes in its results and overall performance
Creativity and Innovation
– The bright, intelligent, and agile ability to approach concepts and complexity comfortably and has a creative and innovative curiosity about our business and industry