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CRA Career Progression & Levels


One’s CRA career progression may be different depending on the company and business environment. However, with motivation and previous experience showing success in clinical research, one should be able to progress in their CRA career either within the same company or at another company. Below are different CRA job title levels that we can use as a rough guide in gauging CRA career progression:

CRA Levels, Job Titles & Descriptions

CRA I (Clinical Research Associate I)

Typical Salary Range: $50,000 to $70,000/yr

This is commonly considered the first level in the CRA career progression. It’s an entry-level CRA role with 1-2 years of experience. CRA I may be working on different parts of a clinical trial, such as setting up trial master files, document preparation, and site correspondence. Some supervision from a more senior CRA may be needed to help guide a CRA I on different clinical trial related functions.

A CRA I is typically an entry-level position in the field of clinical research, aimed at those with some background in life sciences or a related field and perhaps some prior experience in clinical research settings. This role requires strong attention to detail, excellent organizational skills, and the ability to communicate effectively across various levels of the organization. Other duties and functions for a CRA I may be as follows:

  1. Site Monitoring and Management:
    • Conduct site visits to monitor compliance with the study protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
    • Evaluate the performance of the trial at the site, ensuring timely submission of proper data.
    • Oversee the consent process to ensure that it meets ethical and regulatory standards.
  2. Data Collection and Management:
    • Monitor and verify the accuracy of clinical data collected during the study.
    • Review and resolve discrepancies in clinical data with site personnel.
    • Ensure the storage of study documents is secure and in compliance with data protection laws.
  3. Regulatory Compliance:
    • Ensure all necessary site and investigator documents are up to date and compliant with local laws and regulations.
    • Assist in preparing and reviewing submissions to regulatory bodies.
    • Train site staff on regulatory compliance, protocol requirements, and other necessary aspects of the study.
  4. Communication and Reporting:
    • Serve as the primary communication link between the site and the sponsor.
    • Prepare visit reports and other documentation in a timely and accurate manner.
    • Attend project team meetings and provide updates on site status.
  5. Problem Solving:
    • Identify potential study issues and participate in the problem-solving process.
    • Collaborate with other team members to ensure the smooth running of trials.
    • Provide support to sites as needed to handle issues such as patient recruitment or retention.
  6. Training and Development:
    • Participate in ongoing training in clinical trial management and regulations.
    • Assist in the training of new site staff on protocols and compliance issues.
  7. Travel Requirements:
    • Be willing to travel to conduct site visits and audits.

CRA II (Clinical Research Associate II)

Typical Salary Range: $65,000 to $90,000/yr

This is commonly a second level in the CRA career progression. It’s a mid-level position with 3-5 years of experience. A CRA II should be working on all stages of a clinical trial. Job functions can range from clinical trial design and planning, protocol and form generation, site selection, and monitoring, to clinical report generation. A CRA II should be working independently with little or some supervision from more senior CRA. Other duties and functions for a CRA II may be as follows:

  1. Advanced Site Monitoring and Management:
    • Independently conduct site visits, including initiation, monitoring, and close-out visits.
    • Ensure comprehensive oversight of site performance and adherence to trial timelines and protocols.
    • Manage multiple clinical trial sites with minimal supervision, ensuring high-quality data collection and protocol compliance.
  2. Enhanced Data Collection and Management:
    • Take the lead on resolving complex data discrepancies and ensuring the integrity of clinical data through rigorous monitoring.
    • Utilize advanced data management tools to track and report on trial progress.
    • Ensure all clinical data are recorded, processed, and reported according to regulatory standards.
  3. Regulatory Compliance and Leadership:
    • Provide expert guidance on regulatory standards and changes to ensure all trial activities comply.
    • Assist in the development and review of study protocols, informed consent forms, and other documents.
    • Lead interactions with regulatory authorities during audits and inspections.
  4. Communication and Reporting Expertise:
    • Develop and maintain effective relationships with trial site staff, sponsors, and other stakeholders.
    • Prepare and deliver detailed reports and presentations on trial status to senior management and sponsors.
    • Lead team meetings, providing critical updates and strategic guidance.
  5. Complex Problem Solving:
    • Identify, analyze, and lead the resolution of complex trial issues, ensuring minimal disruption to study timelines.
    • Provide strategic solutions to enhance trial efficiency and outcomes.
    • Act as a point of contact for crisis management at clinical sites.
  6. Mentoring and Training:
    • Mentor and support CRA I and other junior staff in clinical trial management practices.
    • Lead training sessions on GCP, regulatory compliance, and specific study protocols.
    • Share best practices and continual learning insights with the team.
  7. Increased Travel Requirements:
    • Travel extensively to manage and monitor trial sites, often handling more complex or problematic sites.

CRA (Clinical Research Associate III) / Senior CRA / Lead CRA

Typical Salary Range: $85,000 to $120,000/yr

This is usually considered the final level in the CRA career progression. It’s a senior-level role with 5 or more years of experience. A CRA III, Sr. CRA, or Lead CRA should be able to perform any of the clinical trial tasks proficiently. They are also expected to supervise, train, and mentor junior CRAs.

A CRA III / Senior CRA / Lead CRA is expected to deliver years of industry experience and deep knowledge of clinical research in their role. This position is important for meeting clinical trial objectives and requires strong leadership skills, an expert understanding of regulations, and the ability to drive improvements in the clinical research process. Other duties and functions for a CRA III may be as follows:

  1. Strategic Site Oversight and Leadership:
    • Lead and manage the clinical monitoring aspects of projects, ensuring compliance with the clinical trial protocol, checking clinical site activities, making on-site visits, and reviewing Case Report Forms (CRFs).
    • Provide authoritative oversight of trial conduct, handling the most complex or high-profile studies.
    • Design strategies for site management to ensure optimal performance and results.
  2. Advanced Data Review and Quality Assurance:
    • Lead role in ensuring data integrity through meticulous monitoring and auditing of trial data.
    • Develop and implement quality control processes to ensure adherence to all study, regulatory, and ethical standards.
    • Oversee the creation and maintenance of trial documentation, ensuring comprehensive audit trails.
  3. Regulatory Compliance and Submission Leadership:
    • Act as a senior expert on regulatory requirements and ensure all aspects of the trial are compliant with SOPs, FDA, and ICH guidelines.
    • Lead submission of protocol, amendments, and other regulatory documents to relevant authorities.
    • Direct interactions with regulatory agencies and respond to their queries.
  4. Expert Communication and Coordination:
    • Facilitate effective communication channels between site staff, trial sponsors, and internal teams.
    • Serve as the main point of contact for major operational aspects of the trial, providing reports and updates to stakeholders.
    • Conduct critical meetings and contribute to strategic planning sessions.
  5. Problem Solving and Innovation:
    • Identify systemic issues in clinical trials and develop innovative solutions to address them.
    • Lead crisis management efforts during clinical trials, ensuring swift resolution of issues with minimal impact on outcomes.
    • Implement new technologies and processes for more efficient trial management.
  6. Mentorship and Leadership in Training:
    • Mentor and guide junior CRAs, CRA Is, and CRA IIs, providing training and development support.
    • Develop training materials and standard operating procedures for clinical trial management.
    • Lead by example in fostering a culture of continuous improvement and high ethical standards.
  7. Comprehensive Travel and Site Management:
    • Extensive travel to oversee trial sites, particularly those that are high-stakes or facing challenges.
    • Manage relationships with trial site personnel to ensure the highest levels of cooperation and performance.

Career Progression Beyond a CRA Role

Many CRAs may choose to remain in CRA role as a career. Some CRAs may become consultants after gaining years of experience. Beyond a CRA role, CRA career progression may include management role such as:

  • Clinical Trial or Clinical Affairs Manager
  • Senior Clinical Trial or Clinical Affairs Manager
  • Associate Director of Clinical Research
  • Director / Vice President of Clinical research

The sky is the limit for opportunities and CRA career progression beyond just a CRA role. One note is that advanced degrees (M.D., Ph.D., MBA, etc.) may be an advantage as one progress higher in clinical research career. Another option is to get a certification through one of the certifying authorities in the clinical research field.

Author

Post author

Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

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