Is a Job in Clinical Research Right for Me?
A job in clinical research does not suit everyone so the first step is to decide if it is the right choice for you. Firstly it is good to have an interest in medical science. An in-depth knowledge of a medical specialty is not essential in many roles. It is often sufficient to have a good general knowledge about the particular medical field in which you may be working and of course you need to understand the objectives of the research. It is important to be interested in why the research is being conducted and how it may benefit the group of patients who are the subject of the study.
Many clinical research jobs require a very good eye for detail, a methodical approach and the ability to plan and manage work in an organised way. Because clinical research involves conducting medical experiments on human beings it is very highly regulated and a disciplined approach is needed to make sure the regulations are being followed and the patients’ rights and wellbeing are protected.
One of the most important factors about all of the roles in clinical research is teamwork. Clinical studies are set up planned and executed by project teams. In most situations everyone has a well-defined role and it is essential that each member is a team player collaborating with their colleagues.
Some roles in clinical research are field-based which involves working from home mixed with plenty of travelling. This suits people who are comfortable working on their own for extended periods of time.
What Does Clinical Research Involve?
Clinical research is an activity that often goes unnoticed by the general public – if you asked a 100 people at random to name a company that specializes in conducting clinical trials probably only one or two people could tell you. However a career in clinical research is very rewarding and is often highly sought after. Clinical research is all about people. It is a discipline that involves research into new medical treatments for the benefit of patients often globally. It requires highly skilled professionals who are not only ethical, scientific and systematic in their approach but also who have strong interpersonal skills.
It is through clinical research that new breakthroughs are made in the treatment of cancer, heart disease and that new vaccines are developed for killers like malaria and Ebola. Medical devices such as artificial heart valves and knee joints are also developed by clinical researchers.
There is a talent shortage in the clinical research industry, however finding a clinical research job has its challenges. Read on to gain some great insights!
A career in clinical research offers a wide variety of choices including disciplines such as medicine, biological sciences, nursing, data management, statistics and IT. The sector offers opportunities for working internationally. There may be the opportunity to work as part of a multinational team both in your home country and abroad. Sometimes it is possible to get temporary secondments in other countries, which can sometimes become permanent depending on the circumstances. The industry is reasonably recession proof and generally well paid compared to other scientific careers. Clinical research is a very dynamic environment. Discoveries in novel medical treatments are often just round the corner.
What Qualifications Do I Need?
As well as the right personal attributes, it is important to have the appropriate qualifications. A clinical research job will often require education to degree level in a related subject. However there are some opportunities for school leavers and apprenticeship programs may be available in some countries which allow people to study for degrees or equivalents and gain work experience at the same time.
Organizations involved in clinical research vary enormously in size, structure and culture. There is plenty of choice, depending on whether you want to work in a large multinational organization, a small start-up company, a contract research company (CRO) or a non-commercial institution such as a hospital, clinic or academic institution.
Clinical research studies are generally set up, managed and financed by organisation known as sponsors. Sponsors come in many shapes and sizes. They range from commercial companies such as pharmaceutical or biotechnology companies, to institutions that include hospitals, universities, and public scientific organisations. Sponsors can delegate trial-related duties to other organizations, such as CROs and this is currently the trend followed by many pharmaceutical and biotechnology companies.
Clinical Research Job Roles
Clinical trials tend to follow the same general format so job roles tend to be fairly standardized from company to company. The various job roles in clinical research reflect the activities to conduct the trial.
Most clinical research and development departments are organized along similar lines in pharmaceutical companies and CROs alike and the job titles are usually fairly consistent. These departments include:
- medical affairs
- clinical operations
- data management
- regulatory affairs
- medical writing
- pharmacovigilance (drug safety)
- quality assurance
- project/program management
In the academic and non-commercial environment, clinical research jobs tend to be less well defined and people tend to take on multiple functions sometimes due to the limits on staff and resources.
Role of Medical Affairs
Typically a significant proportion of this group is made up of qualified physicians. The overwhelming majority of job roles in medical affairs are with pharmaceutical or biotechnology companies. The role of the group in the context of clinical research may include:
- providing medical advice for the design of the protocol and sometimes contributing to its writing
- giving medical advice during the study
- review of safety information and of individual patient safety reports
- responding to medical enquiries by investigators
- writing and reviewing sections of the clinical trial report
Clinical Trial Administrator (CTA) – Starting Point for Future CRAs
This role is office based and involves a range of activities including:
- tracking study progress, maintaining the relevant project tracking systems, and producing periodic status reports for the project team
- preparing and managing the study documentation – the essential documents that make up the trial master file (TMF)
- contacting investigator sites about organisational issues such as study supplies or information about patient recruitment.
The role involves working very closely with the clinical research associates (CRAs). People who make good CTAs are well organized, can prioritise workloads, are thorough, have an eye for detail and have good communication skills.
Working as a CTA can be a good starting point for a career in clinical research. Companies may employ both school leavers with A levels (or equivalent) and new graduates in this role. Sometimes a person who has previously worked in general administration may decide on a career change and discover that this type of work is a good fit.
What Does a Clinical Research Associate (CRA) Do?
The major role of a CRA is to monitor the conduct of the clinical study at investigator sites and to report of their findings and trial progress at each site. The term CRA and Monitor are often used interchangeably and are essentially the same job. Regular visits to each investigator site are made by the CRA to ensure that the rights and wellbeing of the clinical trial subjects are being upheld, the investigators are following the clinical trial protocol and that the data is being recorded accurately and completely. The CRA is also checking to make sure that good clinical practice in general, and local regulations in particular, are being followed. To become a CRA you usually need a biological science degree or nursing qualification.
The CRA role often involves a lot of travel. Depending on their workload, CRAs can be out of the office for most of the working week. Many companies employ field-based CRAs to minimise the amount of travel time so working from home is sometimes an option for this role.
People who start in the CTA role find it a very useful grounding for becoming a CRA. Some companies have dual career paths; one route for those people who want to develop their profession as a CTA and another for individuals who want to pursue a career as a CRA and beyond.
The Role of Data Management
This function may be inclusive of all aspects of data management, including statistics and statistical programming. In some companies these areas may exist as separate groups. The overall role of data management, in collaboration with other departments, is to ensure that a complete and accurate database is compiled to the appropriate quality standards. This is vital as it is only by having an accurate and complete database that statistical analysis can be performed which then allows the conclusions to be drawn about the clinical trial and the evaluation of the new treatment. To find out more about data management visit ACDM.
The Role of the Clinical Data Coordinator/Manager
The primary role of a clinical data coordinator is to ensure that the clinical trial database is accurate and complete. Responsibilities include working closely with CRAs to resolve data queries and conducting quality-control checks on the data. Another important aspect of this job is in the coding of data so that there is consistency in the way that medications, medical conditions and events are described in the trial database.
A typical qualification for a data coordinator is a degree in a biological science. Being a team player and having good communication skills are essential. An eye for detail and a methodical approach are also vital qualities. A Clinical Data Manager is a more senior role and involves database design and data review.
What Does a Clinical Research Statistician Do?
Sometimes known as a biostatistician, this person has a major role in the design of the study and the analysis of the data. Based on the results of previous research and the objectives of the current study, the statistician will select the appropriate statistical significance testing methods to determine whether there is a significant difference in results between the various patient treatment groups. Statisticians also determine the sample size (number of patients in the study) needed to demonstrate statistical significance between the treatment groups.
Statisticians need a degree in statistics or a related subject, good verbal and written communication skills.
Role of Statistical Programmers
This role involves developing, testing and running statistical software for the statistical analysis and reporting of clinical study data. This enables the clinical trial data to be compiled into listings, tables and figures. These components form most of the bulk of a clinical trial report, and form the basis on which the narratives and summary are written.
There are several standard packages of software used in clinical research studies. Much of the role involves troubleshooting and the reporting and fixing of programming errors. Experience with standard clinical programming packages and a degree in a mathematical subject are the typical requirements for this post.
Working in Regulatory Affairs
One of the major roles of Regulatory Affairs groups is to enable the sponsors and CROs to comply with the appropriate regulations and GCP guidelines The group provides information and advice on regulatory submissions and safety reporting and keeps up to date with current regulatory developments..
Regulatory Affairs is involved in the submissions for authorizations to conduct the trial. It is important that the submission is prepared correctly and in a timely fashion to avoid delays at the start of a study.
In pharmaceutical and biotechnology companies, this function also prepares and submits the dossiers for marketing authorization applications (MAAs). This involves collating information from a range of sources, including the results of pre-clinical and clinical research.
Key skills in this role are thoroughness, an eye for detail and the ability to summarise complex and detailed information.
Understanding Medical Writing
The main work of the medical writing group is to coordinate the writing of clinical trial reports. They produce the report templates and ensure that the document is properly formatted, internally consistent and has had the appropriate quality control checks.
As well as the final clinical trial report, medical writers produce sections of protocols, summary documents (for regulatory authorities) and other abstracts.
A life science degree and excellent writing skills are needed for this role.
Working in Pharmacovigilance (Drug Safety)
The function of this group in clinical research, is to coordinate safety reporting during the clinical trial. Part of this role involves preparing safety reporting plan for the study and the respective safety reporting requirements in line with the regulations.
Once the study is underway the pharmacovigilance group will coordinate the reporting of safety information. They will often act as the first point of telephone contact with investigators who need to urgently report safety issues. The group then ensure that the regulatory authorities are informed of the relevant safety information within the required timelines.
This group will collaborate with the medical writers in producing the narratives for the appropriate individual events for the safety section of the clinical trial report.
A life science degree, an eye for detail and excellent writing skills are needed for this role.
Quality Assurance (QA)
The quality assurance (QA) function is responsible for ensuring that their organization has a quality management system that enables the organization to comply with GCP and clinical research regulations. This system must be used and followed by the organization’s staff. It is important that the system is updated and improved in response to regulatory changes and audit findings.
The activities of QA include the coordinating of writing and reviewing of standard operating procedures (SOPs), conducting audits and producing the resulting reports. The QA group will liaise with all functions, providing advice on pinpointing areas for improvement, including identifying training needs.
People who work in QA often have previous experience in other areas such as clinical operations. Thoroughness, an eye for detail, diplomacy and good communication skills are vital for this role.
Working in Clinical Research Project and Program Management
People often move into clinical study project management after several years’ experience in their functional area. Project managers have to have good people management skills as well as project management and have to be used to working to tight timelines and budgets.
Program management involves coordinating the development of an investigational product. The programme manager will be working with several project managers in linking their respective projects into the development program. The program manager should have a good overview of how the development of the new product fits into the business plan of the organization.
Finding Your First Job in Clinical Research
Clinical research, like any other work sector, undergoes fluctuations in supply and demand for labour. There will be local factors as the clinical research job market varies depending where in the world you are based.
Most people find that it is pretty tough to find your first clinical research job, particularly in the commercial sector. The problem is that many employers are looking for previous experience, usually at least 2 years as a minimum. This is especially true for CRA vacancies. One solution may be to take a longer term view at your career. For instance if your goal is to be a CRA, and all the CRA vacancies require previous experience, find a job with an easier entry point such as a CTA role.
If you are a new graduate, another option is to look for organizations that run graduate training programmes. Some CROs have programs like this in place so it is worth enquiring. A significant number of clinical research jobs are ‘interim’, in other words, short term contracts. These can vary in length between 6 months to 2 years and are almost exclusively for people with previous experience. Sometimes a short-term contract can become permanent depending on the business needs of the organization.
If you are a new graduate or have recently finished further education and you are relatively open minded about what you want to do, then spreading your net reasonably wide can be a good tactic.
The more clinical research jobs you apply for, using a targeted approach for each one, the more likely you are to find one. You can use this as the first rung on the clinical research career ladder. Even if you are unsuccessful after a few interviews, look on it as good practise. Treat each as a learning experience and use it to move on!
To help launch your career, contact SEC Recruitment (details on the IN AWE page of the IAOCR website).
By Dr Martin Robinson, Co-Founder and EVP – IAOCR