Seven entry points into clinical research

This article describes seven career paths available to people seeking to break into the field of clinical research.

Clinical research scientist. The clinical research scientist position is involved in managing the clinical investigation (trial) and project teams, track timelines, budgets, and deliverables. The scientist also contribute to the planning of clinical protocols and programs and write documents for submission to regulatory authorities.

Clinical research associate (CRA). A CRA position is the most popular way to enter clinical careers; CRAs are employed both by sponsor companies and by contract research organizations (CROs) that help chaperone a device or drug through clinical investigations and trials. The CRA job is heavy in paperwork and requires good organizational and people skills. There’s always a lot of travel, as the CRA moves from trial site to trial site, monitoring the trials activities, coordinating documentation, and meeting with clinical investigators.

Data manager. The data manager is the architects of systems that produce data. Before a study begins, the data manager review draft protocols for the study to ensure that the study is designed from the beginning with accurate and precise instructions for those responsible for implementing the protocol. The team writes a study data-management plan and confirms that all the reporting forms and data-transfer procedures make sense. Once a study is under way, the group reviews incoming data and maintains its database, ensuring that everyone is following the rules, then hands off the data to the biostatisticians for review.

Biostatistician. The product of a trial — the data — has to be analyzed and interpreted when it starts coming back from the study sites. This is where the biostatistician comes in. The Notified Body or FDA will only approve a product if the data meets certain statistical criteria, so position is very important in a study’s success. Sponsor drug companies use biostatisticians before a trial begins to help set the parameters for data collection and review. But their main work is analyzing the study data and extracting results.

Clinical quality assurance auditor. Clinical quality assurance (CQA) auditors inspect all documents and processes for a study to ensure that they all comply with good clinical practice (GCP) guidelines and standard operating procedures (SOPs). Today, studies are done all over the world, and there is increasing pressure to harmonize standards and procedures. The CQA auditor is in the thick of things in the regulated world of clinical studies, ensuring compliance with ever-changing rules and regulations.

Clinical safety specialist. The clinical safety specialist is responsible for monitoring, coding, organizing, and tracking adverse events that occur during a study. The clinical safety specialist is responsible for reporting adverse events to the competent authorities.

Medical writer. Given the volumes of information that come out of a clinical study and trial, there’s a lot to write about. Medical device companies, pharmaceutical companies, hospitals, government agencies, and medical communications companies need a lot of medical writers.