Could a clinical research associate (CRA) position be the role for you?

Have you been thinking about progressing in your clinical career? Maybe you’re a clinical trial administrator who is ready to take the next step. Well, if this sounds like you, you have come to the right place. In this blog, we are going to be taking you through the role of a clinical research associate (CRA), its salary and whether it may be a position you could see yourself in.

OVERVIEW

1. What is a clinical research associate?
2. What does a clinical research associate do and why is it important?
3. What to expect as a clinical research associate
4. What qualifications do I need to become a clinical research associate?
5. What salary can I expect as a clinical research associate?
6. Career paths
7. Conclusion

1. What is a clinical research associate?

For some of you, this may be the first time you have come across this role. You may have just landed this position. Or, you may have had your eye on it for a while and need a little assistance getting there.

Broadly speaking, as a clinical research associate, you would:

You’ll be involved in all stages of the trial, including identifying an investigational site, setting up, initiating, monitoring and closing down the trial.

CRAs are often employed by a pharmaceutical company or a contract research organisation (CRO) that will work on behalf of a pharma company. However, there is also a third option.
You could choose to freelance as a CRA. However, this is usually a step to take when you have developed vast experience, contacts and clients.

2. What does a clinical research associate do and why is it important?

Good question.

Well, you will certainly play a pivotal role in the coordination and execution of clinical trials. It will be your responsibility to ensure trials are delivered on time and on budget.

Your duties will include:

Check out the list of responsibilities below, which are taken from two real clinical research associate job postings. It details more of the tasks that you are likely to perform in the role.

  • Working as a CRA, you would act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
  • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
  • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations Protocol, Site Monitoring Plan and associated documents.
  • Gains an in-depth understanding of the study protocol and related procedures.
  • Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participates and provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring and oversight activities.
  • Conducts site visits, including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
  • Communicates with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Works with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
  • Participating in study team meetings.
  • Assisting in the preparation of Trial Master Files (TMFs) Investigator Trial Files (ITFs) and Pharmacy Files (PF).
  • Reviewing draft protocols and protocol amendments, case report forms (CRFs), informed consent documents (ICDs), research ethics committee applications using the most current system.
  • Assisting with site selection, assessment and documentation of potential investigational sites through feasibility questionnaires and conducting pre-study visits.
  • Organising, conducting and documenting site initiation visits.
  • Providing training and support to site staff, new SRAs or other personnel.
  • Ensuring sites comply with the clinical trial protocol, policies, SOPs, local regulations and work in accordance with ICH GCP, EU and UK legislation.
  • Conducting pharmacy visits, ensuring investigational medicinal product (IMP) is handled, stored, dispensed, reconciled and returned/destroyed according to clinical trial protocol, SOPs and local policies.
  • Working with Data Management to monitor patients and achieve key performance indicators, including time to patient lock, time to database lock.

3. What to expect as a clinical research associate?

The specific expectations for your role will be dependent on your company and other working conditions. However, as a full-time member of staff, you will work the usual Monday to Friday hours. You should expect to work some evenings, and although weekend work is uncommon, it’s not unheard of.

Part-time work is a possibility, as are short-term contracts of six to 12 months, meaning you’ll be working more as a contractor than an employee.

If your position is field-based then the majority of your time will be spent travelling. This will mean dealing with staff such as research nurses and doctors at trial centres, GP practices or hospitals. It is not uncommon to spend 3–4 days out of the office travelling, with some overnight stays. The rest of your time will be spent either working at the office or from home.

Some CRA roles are much more office-based, in which case your responsibilities will lean towards document management and review.

Depending on the organisation you work for, your CRA role could focus on a specific disease area, and so cover the whole of the UK, or it could function on a regional basis.

If you are working for an international company, you may be expected to coordinate trials abroad.

Basically, if your role is not office-based, invest in a sturdy travel bag!

4. What qualifications do I need to become a clinical research associate?

If so far this role sounds like it could be for you, then the next important question is what is the pathway to becoming a clinical research associate. To begin with, you’ll need to hold a degree or postgraduate qualification in life science, medical science or nursing.

Typically, in your degree, you will need to have studied subjects such as:

If you want the competitive edge that comes from more knowledge in clinical trials, then a postgraduate course in clinical research can help. You can occasionally enter a CRA position from an administrative background without a degree; however, you would need extensive experience and further qualifications to proceed.

Skills you'll need to have:

5. What salary can I expect as a clinical research associate?

Like any role, salary will vary from company to company. Some salary packages may include benefits such as a company car or car allowance, bonuses and pension.

6. career paths

It’s common to think about career progression or where your future job can lead you. A CRA position can open up many other career avenues in the pharmaceutical R&D sector. For example, positions in pharmacovigilance, marketing and regulatory affairs.

Here are some common career paths that CRAs can aspire to – dependent on experience and qualifications:

Career development and progress will vary from company to company and will depend on a number of factors. For example, your prior experience, your motivation to excel, and development and job opportunities within the organisation.

If you work within a contract research organisation, you can increase your experience by working with a variety of sponsor pharmaceutical companies in different therapeutic areas and in different phases of clinical research. This could then enable you to move to a pharmaceutical company.

7. conclusion

Clinical research is changing lives every day and the industry has many in-demand roles just waiting for people with relevant skills and experience.

If you are a clinical trial administrator who has just been promoted to CRA Level I or you have limited experience as a CRA, CGX Training has modular training courses specifically designed for you.

Eager to start your clinical professional career or not sure whether this is the right career for you? Then book a free chat with our friendly team and we’ll be happy to answer any questions you have.

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