Introduction
Clinical Research Associates (CRAs) plan and manage clinical research projects for pharmaceutical, biotech, medical device companies, and contract research organizations (CROs). However, what does a clinical research associate do to ensure that clinical trials comply with ethical and regulatory standards and that the data collected are accurate and reliable? CRAs also play a crucial role in recruiting and monitoring participants, coordinating schedules, reporting results, and liaising with sponsors, investigators, and other stakeholders.
If you want to become a CRA, you may wonder what steps to take to pursue this career path. This blog will outline the education, skills, certification, and experience requirements for CRAs, potential career advancement opportunities, and salary prospects.
Education
To become a CRA, you must have a bachelor’s degree in a health-related field, such as biology, chemistry, nursing, pharmacy, or public health. Some employers may prefer candidates based on what does a clinical data associate do with a master’s degree or a higher level of education, especially for senior or leadership positions. A degree in clinical research or a related discipline can also be beneficial. It can provide theoretical and practical clinical trial design, methodology, management, and regulation knowledge.
Skills
As a CRA, you must have various skills to perform your duties effectively. Some of the essential skills for CRAs include:
Attention to detail
You must be meticulous and thorough in reviewing documents, data, and reports for accuracy and completeness.
Communication
As an employee of an organisation, what does a clinical research associate do is communicate clearly and professionally with various parties involved in clinical research, such as participants, investigators, sponsors, regulators, and colleagues. You will also need to write clear and concise reports and documents.
Organization
You must manage multiple tasks and projects simultaneously, prioritize deadlines, and keep track of schedules, budgets, and resources.
Problem-solving
You will need to identify and resolve issues that may arise during clinical trials, such as protocol deviations, adverse events, data discrepancies, or participant dropouts.
Teamwork
As a CRA, you need to collaborate and coordinate with other CRAs. What does a clinical trial associate do is collaborate with their clinical research staff within the organization or across different sites.
Technical
You must be proficient in using various software applications and tools for data entry, analysis, and reporting. You must also be familiar with electronic data capture (EDC) and clinical trial management systems (CTMS).
Certification
While certification is not mandatory to become a CRA, it can demonstrate your competence and professionalism in clinical research. If you are looking for what is the scope for clinical research, certifications can also enhance your credibility and employability with potential employers. Several organizations offer certification programs for CRAs, such as:
Clini Launch Research Institute (CLRI)
Clini Launch Research Institute offers the Certification for Clinical Research Associate credentials for CRAs with full-time experience as a CRA. To obtain credentials in CCRA, you must pass an examination covering regulations and guidelines, clinical trial operations, data management, quality assurance, ethics and safety.
Society of Clinical Research Associates (SOCRA)
SOCRA offers the Certified Clinical Research Professional (CCRP) credential for CRAs with at least two years of full-time experience in clinical research. To obtain the CCRP credential, you must pass an exam covering clinical trial design and conduct, regulations and guidelines, ethics, data management, quality assurance, and professional development.
International Academy of Clinical Research (IAoCR)
IAoCR offers the Certified Clinical Research Associate (CICRA) credential for CRAs with at least one year of full-time experience in clinical research. To obtain the CICRA credential, you must complete an online course covering clinical trial planning, monitoring, reporting, and auditing.
Experience
To become a CRA, you must gain relevant clinical research experience. Based on the experience, what does a clinical trial associate do can help you develop your skills, knowledge, and network in the field. There are several ways to gain experience as a CRA, such as:
Volunteering or interning
You can look for opportunities to volunteer or intern with clinical research organizations, hospitals, universities, or non-governmental organizations that conduct clinical trials. The CRAs can help you gain exposure to the different aspects of clinical research, such as recruitment, data collection, and documentation.
Working as a clinical research coordinator or assistant
You can apply for entry-level positions as a clinical research coordinator (CRC) or a clinical trial assistant (CTA) with clinical research organizations, hospitals, or academic institutions. These positions involve supporting the CRAs and investigators in conducting clinical trials, such as screening and enrolling participants, collecting and entering data, maintaining records, and communicating with sponsors and regulators. Working as a CRC or a CTA, what does a clinical trial assistant do is help you gain hands-on experience and skills in clinical research and prepare you for the role of a CRA?
Networking and mentoring
You can network with other professionals in the field of clinical research, such as CRAs, investigators, sponsors, regulators, and educators. You can attend events, workshops, webinars, or conferences related to clinical research, join online forums or groups, or participate in professional associations or societies. Networking can help you learn from the experiences and insights of others, as well as find potential opportunities or referrals for CRA positions. As an employee, what does a clinical research associate do is seek mentorship from experienced CRAs who can guide you through the career path, provide feedback and advice, and support your professional development.
Career Advancement
As a CRA, you can advance your career by taking on more responsibilities, challenges, and leadership roles in clinical research. Some of the potential career advancement opportunities for CRAs include:
Senior CRA
A senior CRA is a CRA who has more experience and expertise in clinical research. A senior CRA may oversee multiple clinical trials or sites, provide training and supervision to junior CRAs, and act as the main point of contact for sponsors, investigators, and regulators. A senior CRA may also be involved in designing, planning, and managing clinical trials and ensuring quality control and compliance.
Lead CRA
A lead CRA is a CRA who leads a team of CRAs in conducting clinical trials. A lead CRA may be responsible for assigning tasks, monitoring performance, and providing feedback to the CRAs in their team is what does a clinical research associate do. A lead CRA may also coordinate with other teams or departments involved in clinical research, such as data management, biostatistics, medical affairs, and regulatory affairs.
Clinical Research Manager
A clinical research manager is a professional who manages the overall operations and activities of a clinical research organization or department. A clinical research manager may oversee the planning, execution, and completion of multiple clinical trials or programs and manage the budget, resources, and staff. A clinical research manager may also ensure that clinical trials follow the protocols, regulations, and quality and safety standards.
Clinical Research Director
A clinical research director is a professional who directs the strategy and vision of a clinical research organization or department. A clinical research director may set the goals, objectives, and policies for clinical research and evaluate the performance and outcomes of the clinical trials or programs. A clinical research director may also liaise with senior management, sponsors, investigators, regulators, and other stakeholders to ensure alignment and collaboration in clinical research.
Salary
The salary of a CRA may vary depending on several factors, such as education, experience, certification, location, and employer. According to Glassdoor, the average salary for a CRA in India is ₹5,93,000 per year. The salary range for a CRA in India ranges from ₹2,40,000 to ₹12,00,000 per year.
Conclusion
A career as a CRA can be rewarding and challenging for those interested in conducting clinical research to improve health outcomes and advance medical science. To become a CRA, you must have a degree in a health-related field and skills in attention to detail, communication, organization, problem-solving, teamwork, and technical proficiency. To become a clinical research associate, what does a clinical research associate do to gain experience in clinical research before they consider obtaining certification from a reputable organization? As a CRA, you can advance your career by taking on more responsibilities and leadership roles in clinical research. The salary of a CRA may vary depending on several factors.
If you are looking for a career that combines science and health care with project management and quality assurance, a career as a CRA may be right for you.
