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Clinical Research Professional

Clinical Research Professionals are involved in the writing, executing, and monitoring of human subject research on drugs, biologics, and medical devices for the pharmaceutical industry.  It is not one profession by itself but rather a collection of individual job roles that assist in various aspects of bringing products to the marketplace.  The individual professions that contribute to this effort include the Clinical Research Associate/Clinical Research Coordinator, the Regulatory Affairs Professional and the Clinical Data Manager.

Clinical Research Associates/Clinical Research Coordinators (CRA/CRC):
Clinical Research Associates help design and monitor clinical research studies especially drug and device trials when conducted on humans.  They help design research studies and assist in the writing of detailed research protocols.  If they are employed by a research site they are commonly referred to as Clinical Research Coordinators (CRCs). If they work for the Sponsor (usually a Pharmaceutical Company) or a Contract Research Organization (CRO) they are commonly referred to as Clinical Research Associates (CRAs).  CRCs actually conduct the studies along with a Principal Investigator.  They are normally responsible for training and coordinating staff activities, recruiting and screening human subjects and also develop and obtain informed consent from research participants.  The CRAs include training and coordinating all research personal at several investigative sites.  They visit the sites and ensure that the clinical trial staff is following all governmental and ethical regulations, and participates in any audits. CRAs work for pharmaceutical companies, biotechnology firms, medical device manufacturers, medical research universities, government agencies and contract research organizations.

Patient Recruitment Specialist (PRS):

The Patient Recruitment Specialist is a new job role to the pharmaceutical industry.  The biopharmaceutical industry has emphasized the need to develop cost effective strategies for patient recruitment and retention.  The PRS may be involved in testing out the validity of these strategies scientifically in order to speed up the drug approval process.  These individuals also develop the tools and processes for effective recruitment activities and implement these along with the CRAs/CRCs at investigative sites globally.  The PRS may work for the sponsor, CRO, or for independent companies that specialize solely in global recruitment.

Regulatory Affairs Professionals
The Regulatory Affairs Professional collects and interprets FDA and International regulations governing the promotion of pharmaceutical products.  They are responsible for planning a regulatory strategy to ensure marketing approval and provide assistance in the collection, review, and preparation of regulatory filings such as New Drug Applications (NDA).  In addition these professionals are also active participants in evaluating drug safety.  The Regulatory Affairs Professional may also be involved in quality assurance activities in the drug development and also in manufacturing arena.

Clinical Data Manager
The Clinical Data Manager is involved in designing and using software involved in data capture and mining from clinical research sites.  They are also involved in traditional data management activities such as database audits, coding, and in identifying signals suggesting serious adverse drug or device reactions.  The Clinical Data Manager will assist team members in utilizing the appropriate research designs from a data collection approach and in designing electronic forms and reports that collect data on product efficacy and adverse events.   These individuals also assist with the flow of information from the research site to the biopharmaceutical industry and then to the appropriate regulatory agency.

Drug Safety Officer/Pharmacovigilance Specialist
Drug Safety Officers monitor the safety of drugs, biologics and medical devices. They review reports of adverse events from patients, regulatory agencies, healthcare professionals, and investigational sites, and then write safety reports for the Healthcare Authorities.  They are also involved in data mining to screen for adverse events (signal detection) and assess the risk and benefits of medical products, as well as develop risk management plans.  A clinical background is preferred as well as a thorough understanding of the regulatory requirements both in the US and abroad. However there are individuals who may fill positions in drug safety departments who are involved with data collection and report writing and do not necessarily require past clinical experience.

Rutgers School of Health Professions



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