Clinical Research is a branch of Life Sciences that investigates the safety and effectiveness of new treatments and the suitability of these treatments for human use. Particularly over the past 18 months, the global Clinical Research market is continuously growing and evolving, with more and more career opportunities becoming available within this vast field.
In 2020, the global Clinical Trials market was estimated at $44.3 billion, and this is expected to grow at an annual rate of 5.7% between 2021 and 2028. The National Institute for Health Research (NIHR) also recorded that between April 2020 and March 2021, 1,390,483 participants took part in Clinical Research across England, which is almost double the numbers from the previous year.
The huge growth in this industry is also evident in the noticeable increase in the number of available career opportunities within Clinical Research. Over the past year, the average number of Clinical Research jobs on PharmiWeb.Jobs has doubled, and this continues to be the discipline with the most available opportunities on our job board.
In this article, we look at 10 different career paths within Clinical Research, with an outline of some of the most common responsibilities for each role…
Clinical Trials Manager / Administrator
Clinical Trials Managers / Administrators are responsible for the administrative aspects of clinical trials. Their duties often include:
- Preparing essential documents and ensuring documentation is kept private and confidential.
- Attending safety and study start-up meetings and coordinating investigator meetings.
- Managing clinical trial supplies.
- Reviewing trial protocols and identifying any protocol issues.
- Processing and tracking payments to investigator sites.
Clinical Research Associate (CRA)
CRAs are responsible for organising and administering clinical trials and are typically involved in all stages of a trial, from identifying investigator sites to closing down the trial. The responsibilities of a CRA can include:
- Identifying suitable facilities to be used as trial sites and selecting an investigator to be responsible for the site.
- Briefing trial investigators and instructing clinicians on how the trial should be conducted.
- Writing up clinical trial methodologies and designing trial materials.
- Monitoring the progress of clinical trials and preparing final reports.
- Designing and authenticating data collection forms and managing regulatory applications/approvals.
Clinical Project Manager
Clinical Project Managers are responsible for managing the workers involved in clinical research projects, ensuring protocol compliance whilst coordinating projects to meet clinical objectives. The main responsibilities of a Clinical Project Manager may include:
- Overseeing the enrolment of subjects into clinical trials by assessing the eligibility of potential subjects and tracking the enrolment status of suitable participants.
- Ensuring compliance with protocols and informing investigators of any protocol issues.
- Monitoring study activities to ensure the study remains on schedule and is kept within allocated budgets.
- Maintaining records of study activity, including records of side effect data.
Pharmacovigilance / Drug Safety Officer
Pharmacovigilance Officers, also known as Drug Safety Officers, are responsible for ensuring that new and existing drugs on the market are safe for patients, and for identifying any issues with these drugs. They may be responsible for:
- Monitoring the effectiveness of new drugs and pharmaceutical products already on the market.
- Monitoring adverse effects to new or existing drugs and flag any early warning signs of these to minimise risk.
- Conducting interviews with patients and healthcare professionals.
- Completing safety update reports and conducting safety audits.
Study Start Up Associate
Study Start Up Associates are integral in making sure that clinical research sites are well prepared to begin a new trial. They can be involved in the following:
- Executing start-up activities before site activation including preparing consent forms, identifying new investigator sites, allocating study budgets, and supporting patient recruitment and retention.
- Ensuring physicians working at research sites are prepared to begin trials.
- Obtaining appropriate ethics and regulatory approvals and ensuring research operations comply with protocols.
- Analysing study start-up metrics to ensure efficiency and identifying areas for development, including in terms of start-up timelines.
Clinical Research Nurse
Clinical Research Nurses help to improve patient care by supporting patients through their treatment, ensuring they are both safe and fully informed of the study activities. Some of their main responsibilities could include:
- Helping to develop new treatments and care pathways for patients.
- Aiding data collection activities.
- Ensuring patients give full consent prior to being enrolled in clinical trials and making sure patients fully understand all aspects of the study before doing so.
- Assisting the principal investigator with pre-study preparation and study start-up activities, including preparing protocols for regulatory and ethical approval, and attending investigator meetings.
- Arranging appointments for potential and enrolled trial participants.
Clinical Research Scientist
Clinical Research Scientists are responsible for undertaking medical research in research labs to find more effective ways of diagnosing and curing a variety of illnesses. They may also be responsible for:
- Interacting with patients taking experimental treatments to understand the effectiveness of these treatments and to investigate new ways of improving their wellbeing.
- Working with other medical staff to advise on how to use products and equipment already on or coming to the market.
- Analysing data to further develop treatments and test any new methods of diagnosis and treatment.
Clinical Investigators ensure that the investigation is meeting research expectations and is conducted in line with the investigator statement, investigational plan, and all necessary regulations. By doing so, they protect the welfare of clinical trial participants as well as the integrity of the resulting data. Their responsibilities can include:
- Meeting specific guidelines and/or requirements set by applicable regulatory and ethical bodies.
- Conducting or supervising research to ensure the investigational plan and corresponding study protocols are being followed.
- Notifying relevant bodies of any changes in research activity, including any unanticipated obstacles that may introduce risk to study participants.
- Ensuring informed consent has been obtained from all participants.
- Maintaining records of the clinical studies and preparing reports to be sent to investigation sponsors and other relevant bodies.
Patient Recruitment Specialist
Patient Recruitment Specialists are responsible for recruitment-related activities. Their main responsibilities include:
- Recruiting participants in line with protocol-specific inclusion and exclusion criteria.
- Tracking recruitment progress and developing new and existing recruitment strategies.
- Contacting potential participants to assess eligibility and to schedule site visits.
- Ensure patient information is accurately collected and entered into the relevant database and is protected.
Biostatisticians provide statistical support to clinical studies and work across all study phases. Typically, their work can include:
- Obtaining clinical data from the Clinical Data Manager to undertake necessary statistical analyses. Interpreting the meanings of statistical outputs resulting from different analyses.
- Assisting the Clinical Trial Manager in writing up the final technical paper for the study, sharing findings from statistical analyses.
- Analysing safety and efficacy data and applying statistical methods to develop the science of data analysis.
Current Opportunities in Clinical Research…
Clinical Research is a desirable career option due to competitive salaries, opportunities to travel and good levels of future job security. Work in Clinical Research can be challenging, but it can also be extremely rewarding and varied, and the industry is constantly evolving.
Take a look at current opportunities in Clinical Research here and set up job alerts to be notified of the latest opportunities in the industry.