The entry level clinical research roles of Clinical Trial Assistant (CTA) and Clinical Research Coordinator (CRC) both offer hands-on experience in the daily operations of clinical trials.

However they have some crucial differences that may appeal to different types of applicants. In this article we look into the daily requirements and responsibilities of these roles, and what qualities each role might require.

Clinical Research Coordinators (CRCs)

The Clinical Research Coordinator manages the day-to-day operations of clinical trials at the site level. They are often based in hospitals, clinics, or research centers and have direct interaction with patients and healthcare professionals. 

Key Responsibilities and Skills

• Patient Interaction and Recruitment:
  • Recruit and enroll study participants.
  • Conduct informed consent discussions.
  • Act as the main point of contact between the study site and sponsors.
• Data Management and Compliance:
  • Collect and manage clinical data.
  • Ensure compliance with study protocols and regulatory requirements.
  • Maintain accurate documentation and strictly follow protocols.
• Administrative Tasks:
  • Coordinate various study activities.
  • Communicate complex medical information to participants and liaise with stakeholders.
  • Improve study processes and patient care.

This role blends patient care with administrative tasks so it would be good for someone with interpersonal and communication skills as well as strong organizational skills. 

In return, the CRC can see the immediate impact of their work on patient outcomes and study progress.

Attributes of a Successful CRC

• Good interpersonal and empathic skills for patient interactions.
• Strong problem-solving skills to address issues that arise during trials.
• Collaborative and proactive with colleagues.
• Detail-oriented for managing study protocols and data collection.
• Strong organizational skills for coordinating study activities.
• Empathy and strong communication skills.

CRCs also act as the main point of contact between the study site and sponsors.

As an entry level research role, CRCs can go on to Senior CRC then Project Manager or Clinical Trial Manager.

CRCs and CTAs do have similarities in their working conditions. However, CRCs should expect to spend time away from their desks and to be in environments where they can interact directly with patients and healthcare teams, such as hospitals, clinics, or research centers. As the role often involves a mix of office work and a clinical site presence for patient interactions and data collection, CRCs enjoy a more fast-paced environment.

The role can be demanding, with irregular hours due to the need to accommodate participant schedules and study timelines. Travel may also be required for multi-site studies.

Clinical Trial Assistant (CTA)

Clinical trial assistants play a vital role in providing administrative support to clinical research teams. Their position is typically office-based within pharmaceutical companies, contract research organizations (CROs), or academic institutions. Their daily focus is on documentation and administrative tasks rather than direct patient interaction.

Key Responsibilities and Skills

• Documentation and Regulatory Tasks:
  • Maintain and organize study documentation and regulatory files.
  • Assist with the preparation and submission of regulatory documents.
  • Ensure documents and study files are complete and accurate.
  • Vendor and supplier management  (drug supply, study equipment  etc).
  • Study tracking.
• Administrative Support:
  • Coordinate meeting schedules.
  • Support Clinical Research Associates (CRAs) with monitoring visit preparation and follow-up.
  • Manage study documentation.
  • Prepare regulatory submissions.
  • Coordinate meetings.

The CTA’s day may be a more structured environment than the CRC, where they can focus on detailed tasks and support the larger clinical research team. Focusing on the behind-the-scenes aspects of clinical trials, they are primarily desk-based work. While standard office hours are common, just as with CRAs, overtime may be required to meet project deadlines.

Attributes of a successful CTA

• Strong organizational and administrative abilities.
• Attention to detail for maintaining accurate documentation.
• Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Adaptability to changing regulatory requirements and study protocols.

Starting as an entry-level role, CTAs can progress to positions such as Clinical Research Associate (CRA), Regulatory Affairs Specialist, Clinical Project Manager, or Regulatory Affairs Manager.

 

Similarities between entry level clinical research roles

The daily working lives of clinical trials assistants and clinical research coordinators share several similarities despite focusing on different aspects of the trial process. Both maintain and organize study documentation, ensuring that all records are complete, accurate, and comply with regulatory requirements. Both roles require that attention to detail and use similar software to manage data. A knowledge of the regulatory landscape and frameworks for operating clinical trials are also essential requirements for both of these roles.