Careers in Clinical Operations (CRA, CRC, etc)

Clinical operations professionals are involved in the conduct of Phase I to Phase IV clinical trials primarily for the pharmaceutical and biotech companies. They ensure and strive to maintain the highest standards of ethics, quality and confidentiality. Clinical Operations professionals usually have extensive experience in project management in several therapeutic areas such as Oncology, Metabolism, Cardiovascular diseases etc. This experience comes handy in conducting and managing large scale global clinical trials. Clinical operations professionals are usually either employed within pharmaceutical or contract research companies and they effectively collaborate with investigative clinical trial sites to manage clinical trials. They employ various technologies to streamline the collection and dissemination of clinical data.

Few common job profiles that are available in the department of Clinical Operations are:

– Clinical Research Coordinator (CRC)
– Clinical Research Associate (CRA)
– Clinical Trial Manager (CTM)

CLINICAL RESEARCH COORDINATOR

Known in the industry by multiple titles such as a Clinical Trial Coordinator, Clinical Study Coordinator, Research Coordinator, Study Coordinator etc a Clinical Research Coordinator (CRC) is one of the key members of the study site staff. They are specialized research professionals who work directly under the Principal Investigator (PI) and ensure that the safety of the patients prevails over the innovation in science. Clinical research coordinator facilitates and coordinates the daily trial schedule activities. They play a significant role in conducting clinical research studies by acting as a connecting link between the Principal Investigator (PI), sponsor, ethics committee, institution and sometimes even a central laboratory. Being a part of the site staff they interact directly with the subjects enrolled in a clinical trial. Clinical Research Coordinators may provide guidance to the administration regarding compliance, finance affairs, personnel and various other aspects that are related to the clinical study and research development. A Clinical Research Coordinator is also responsible for collecting data and ensuring the accuracy of all data transcriptions. An experienced CRC at a site may also have a responsibility to monitor the activities occurring in their clinical trial site.

Competencies & Skills:

Various competencies and skills are required to make a career as a Clinical Research Coordinator. Some of them are:

– Thorough understanding of the drug development process with sound knowledge of ICH-GCP
– Excellent interpersonal and communication skills
– High Confidence
– Multi-tasking ability
– Self-motivation
– Effective problem solving skills
– Decision making ability

Education:

– Graduation in Pharmacy or any Science related field is highly recommended

RECOMMENDED PROGRAM

To work as a Clinical Research Coordinator we suggest you consider the following online program(s):

– Post Graduate Diploma in Clinical Research
– You may also choose one of the Advanced Post Graduate Diploma Programs in Clinical Research based on your preferred specialization