cra clinical research associate job description

Clinical Research Associate Job Description [Updated for 2024]

In the modern healthcare industry, the role of Clinical Research Associates is indispensable.

As the healthcare landscape progresses, the demand for skilled professionals who can execute, manage, and ensure the quality of clinical research escalates.

Let’s delve deeper: What is truly expected from a Clinical Research Associate?

Whether you are:

• A job seeker wanting to understand the core aspects of this role,
• A hiring manager outlining the perfect candidate,
• Or simply fascinated by the intricacies of clinical research,

You’ve found the right place.

Today, we present a customizable Clinical Research Associate job description template, designed for effortless posting on job boards or career sites.

Let’s dive right in.

Clinical Research Associate Duties and Responsibilities

Clinical Research Associates play a crucial role in clinical trials and research studies.

They are involved in every stage of the process, from planning to data collection, analysis, and reporting.

They often work in a team with other scientists, researchers, and healthcare professionals.

Their duties and responsibilities include:

• Designing and implementing clinical research studies and trials
• Preparing protocols for clinical trials
• Monitoring the progress of research activities and ensuring they adhere to protocols
• Collecting, processing, and managing research data
• Conducting site visits, field monitoring, and data auditing
• Ensuring all research activities comply with regulatory standards and ethical guidelines
• Preparing reports and presentations to communicate research findings
• Communicating with clinical study sponsors, investigators, and other team members
• Participating in patient recruitment and screening activities
• Coordinating and managing logistics of clinical trials, including materials, equipment, and participant care
• Training and supervising junior staff and ensuring they adhere to clinical trial protocols and standards

Clinical Research Associate Job Description Template

We are looking for a dedicated Clinical Research Associate to assist with the design, execution, and maintenance of clinical trials.

The Clinical Research Associate’s responsibilities include creating and implementing research protocols, interpreting the data, writing reports, and ensuring all trials are conducted in compliance with the clinical protocol, and regulatory and ethical standards.

Our ideal candidate has experience in a clinical research environment, with a strong understanding of medical terminology, clinical trials, and research protocols.

Responsibilities

• Assist in the design and development of clinical research protocols
• Monitor clinical trials and studies to ensure compliance with protocol
• Coordinate with clinical investigators and staff to resolve queries and manage data
• Prepare and present detailed reports and documents for clinical trials and studies
• Conduct periodic site visits to ensure protocol adherence and integrity of collected data
• Ensure all adverse events are reported in a timely and accurate manner
• Maintain regulatory documentation according to the regulatory requirements
• Participate in the preparation and review of study reports and manuscripts

Qualifications

• Proven work experience as a Clinical Research Associate
• Knowledge of good clinical practices (GCP), FDA regulations and guidelines
• Excellent understanding of medical terminology, clinical trials, and research protocols
• Proficiency in data analysis and documentation
• Strong organizational and communication skills
• Ability to travel for monitoring visits
• Bachelor’s degree in Life Sciences, Nursing or a related field
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

Additional Information

• Job Title: Clinical Research Associate
• Work Environment: Clinical settings, with options for remote work. Travel is required for site visits and meetings with clinical investigators.
• Reporting Structure: Reports to the Clinical Research Manager or Clinical Operations Manager.
• Salary: Salary is commensurate with experience and qualifications, as well as market and business considerations.
• Pay Range: $60,000 minimum to $90,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

What Does a Clinical Research Associate Do?

Clinical Research Associates (CRAs) primarily work for pharmaceutical and biotechnological companies, contract research organizations, or government health departments.

They play a critical role in the research and development of new drugs, medical devices, and procedures.

They are responsible for setting up, monitoring, and completing clinical trials, which are tests or studies done to evaluate the effects of medical or surgical interventions on human subjects.

CRAs are responsible for ensuring the trials adhere to the trial protocol, are conducted ethically, and are in compliance with regulatory standards and guidelines.

They also ensure that data collected from the trials is accurate, complete, and verifiable from source documents.

Their job involves frequent travel to the clinical trial sites to monitor the progress of the trial, review the data collected, and to ensure the safety and wellbeing of the trial participants.

They are also involved in the design and writing of trial protocols, case report forms, and consent forms, and work closely with doctors, other healthcare professionals, and trial participants.

In addition, they may also liaise with regulatory authorities and ethics committees regarding the approval of trial protocols, amendments, and serious adverse event reports.

Their role is critical in the drug development process and contributes significantly to the advancement of medical science and patient care.

Clinical Research Associate Qualifications and Skills

Clinical Research Associates should have a set of skills and qualifications that align with the job description, including:

• Thorough knowledge of clinical research principles, regulations and procedures to ensure compliance with ethical, legal and safety requirements.
• Strong analytical and critical thinking skills to evaluate and interpret clinical data and identify any inconsistencies or deviations.
• Excellent attention to detail in order to accurately document and report results from clinical trials.
• Strong organizational and time management skills to manage multiple tasks, prioritize effectively, and meet deadlines.
• Effective communication skills to clearly and effectively interact with all levels of clinical staff and participants, and to write comprehensive reports.
• Interpersonal and team working skills to collaborate with a diverse team of professionals such as clinical investigators, medical specialists, and laboratory technicians.
• Problem-solving skills to address and resolve any issues or obstacles that may arise during the conduct of clinical trials.
• Ability to remain adaptable and resilient in high-stress situations or when dealing with unexpected results or challenges.

Clinical Research Associate Experience Requirements

For entry-level Clinical Research Associate positions, candidates usually need 1 to 2 years of relevant experience, which can be obtained through internships, part-time roles, or relevant healthcare positions.

These professionals may also gain experience in roles such as Clinical Research Coordinator, Clinical Data Analyst, or other healthcare-related roles.

Candidates with more than 2 years of experience often develop their clinical research skills and knowledge in entry-level Clinical Research Associate roles or similar positions, where they gain hands-on experience in clinical trial procedures, regulatory requirements, and data management.

Those with more than 5 years of experience may have some leadership experience in their background and are usually ready for roles such as Senior Clinical Research Associate or Clinical Trial Manager.

They may also have completed advanced training or certifications related to clinical research or the specific field of study.

Additionally, many employers prefer candidates with a background in life sciences, nursing, or medical sciences.

Advanced degrees such as a Master’s or PhD in a relevant field can also substitute for some experience requirements.

Clinical Research Associate Education and Training Requirements

Clinical Research Associates (CRA) typically require a bachelor’s degree in life sciences, medical sciences, nursing, or related field.

They also need to have a good understanding of clinical research processes, medical terminologies, and regulatory standards.

Familiarity with Good Clinical Practice (GCP) is also essential.

Many employers prefer candidates with a master’s degree in a health-related field or an equivalent combination of education and experience.

Courses in biostatistics, clinical trials design, and ethics are particularly beneficial for this role.

Some positions may require CRAs to have certification from organizations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

This certification typically requires a combination of education, experience, and a passing score on an examination.

Continuing education is crucial in this field as regulatory guidelines and medical knowledge continually evolve.

Advanced coursework or training in clinical data management, ethics, and patient safety can prove highly beneficial.

Work experience in clinical research is highly valued, which can be obtained through internships, cooperative programs, or direct employment in healthcare facilities or research laboratories.

The role also demands excellent communication, attention to detail, organizational skills, and the ability to handle multiple tasks simultaneously.

Clinical Research Associate Salary Expectations

A Clinical Research Associate can expect an average salary of $76,506 (USD) per year.

The actual earnings can vary significantly depending on factors such as the level of experience, education, the employing company, and the location of the job.

Clinical Research Associate Job Description FAQs

What skills does a clinical research associate need.

A Clinical Research Associate should possess excellent analytical and organizational skills to effectively manage the research process.

They must have strong attention to detail to ensure the accuracy of data and should have excellent written and verbal communication skills to clearly present findings.

Moreover, they should have a deep understanding of clinical trial processes and be able to work collaboratively with various medical professionals.

Do Clinical Research Associates need a degree?

Yes, a bachelor’s degree in life sciences or a related field is typically required for entry-level positions.

However, a master’s degree or a Ph.D. is often preferred, especially for more senior roles.

Clinical Research Associates also require extensive training in clinical practices, ethics, and regulations.

What should you look for in a Clinical Research Associate resume?

When reviewing a Clinical Research Associate’s resume, look for a degree in life sciences or a related field, and any additional qualifications or certifications in clinical research.

You should also look for experience in clinical trials, including study design, data collection and analysis, and report writing.

Proficiency in using clinical research software and familiarity with FDA regulations and Good Clinical Practice (GCP) guidelines is also important.

What qualities make a good Clinical Research Associate?

A good Clinical Research Associate is a critical thinker, able to analyse complex data and identify trends or patterns.

They are meticulous, ensuring that every detail of the research process is accurately documented and reported.

They are also ethical, ensuring that all research is conducted in line with established protocols and guidelines.

Good Clinical Research Associates are also proactive, able to anticipate and resolve issues before they become problems.

What are the daily duties of a Clinical Research Associate?

A Clinical Research Associate’s daily duties typically include designing and implementing clinical trials, collecting and analyzing data, conducting site visits, and ensuring compliance with protocol.

They monitor progress of studies, ensuring they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

They may also spend time liaising with doctors or consultants, writing reports, and presenting findings.

There you have it.

Today, we’ve delved deep into the intricacies of what it truly means to be a Clinical Research Associate .

It’s not just about conducting research.

It’s about shaping the future of healthcare, one research study at a time.

With our comprehensive Clinical Research Associate job description template and real-world examples, you’re now ready to take that leap.

But why settle there?

Dig deeper with our job description generator . It’s your essential tool for developing laser-focused job listings or honing your resume to perfection.

Every research study contributes to the bigger picture.

Let’s shape the future of healthcare. Together.

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The Job Description of a Clinical Research Associate

Clinical research associates are also referred to as CRAs. They are responsible for organizing and administering clinical trials of a current or new drug to assess and determine the risks and the benefits associated with using them. Clinical research associates are often employed by clinical contract agencies and pharmaceutical companies. There are many things that a clinical research associate needs to handle, and we will discuss them in this article.

Their responsibilities

The key responsibilities that a clinical research associate has to carry out in their course of duty include:

 Writing reports

 Progress monitoring during the trial duration

 Collection and authentication of forms that are used for data collection

 Giving the clinicians instructions about how trials are to be conducted

 Designing different trial materials as well as providing different study centers that have sufficient quantities

 Setting up the trial centers and then disbanding them

 Identifying the clinicians and briefing them

 Writing down the procedures of the drug trials

The employers

Typical employers include:

 The academic departments in hospitals

 Clinical contract houses and agencies (CROs)

 Pharmaceutical companies

Available vacancies are usually advertised in the national newspapers, online, specialist agencies, and very specific journals. This field is very competitive, therefore it can be useful for applicants to have the relevant analytical and scientific techniques. In addition, pharmaceutical research, medical sales, nursing, or laboratory work knowledge can be very useful in clinical research associate positions.

The process of recruitment involves an interview, which is very technical. You will need to be trained to get the kind of qualifications that are necessary to excel in this area. To achieve this, you need to be qualified in life sciences or medical sciences. To learn more about clinical research professional courses, visit CCRPS .

Unveiling the Role of Clinical Research Associates

Clinical Research Coordinator : Dive into the responsibilities and skills required for effective clinical research coordination.

Pharmacovigilance Certification : Explore the essential aspects of pharmacovigilance to ensure drug safety and regulatory compliance.

CRA (Clinical Research Associate) : Delve into the core responsibilities and duties of a Clinical Research Associate in managing clinical trials.

ICH-GCP : Understand the principles and guidelines outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP).

Clinical Trials Assistant Training : Acquire the foundational knowledge and skills necessary to support clinical trial operations effectively.

Advanced Clinical Research Project Manager Certification : Elevate your expertise in clinical research project management with advanced certification training.

Advanced Principal Investigator Physician Certification : Gain advanced certification tailored for Principal Investigator Physicians involved in clinical research studies.

Medical Monitor Certification : Explore the critical role of medical monitoring in ensuring the safety and integrity of clinical trials.

Different Categories of Clinical Research Jobs Available as Careers

Understanding the scope of clinical research and what it entails.

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What is a Clinical Research Associate ?

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Clinical Research Associate Job Description Template

Job overview, clinical research associate responsibilities & duties.

• Monitor clinical trials to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements
• Perform site selection, initiation, monitoring, and closure visits in accordance with study plans
• Review and verify case report forms (CRFs) for accuracy, completeness, and consistency with source documents
• Conduct source document verification to ensure data integrity
• Liaise between the sponsor and clinical trial sites to address issues and ensure smooth study progress
• Ensure timely reporting and resolution of adverse events
• Maintain up-to-date study documentation and records
• Assist in the preparation and submission of regulatory documents
• Provide training to site staff on the study protocol and best practices
• Ensure proper storage and handling of investigational products at clinical sites
• Foster strong relationships with site investigators and staff
• Prepare and present monitoring visit reports to the sponsor
• Assist in the development and review of study protocols and informed consent forms

Clinical Research Associate Qualifications & Skills

• Previous experience as a Clinical Research Associate or similar role
• Advanced degree in a related field, such as a Master's or PhD
• Familiarity with electronic data capture (EDC) systems
• Proficiency in multiple languages
• Experience working in various therapeutic areas
• Strong understanding of regulatory requirements and guidelines
• Certification from recognized clinical research organizations, such as SOCRA or ACRP
• Excellent communication and interpersonal skills
• Bachelor's degree in life sciences, health sciences, or a related field
• Minimum of 1-3 years of experience in clinical research or a related field
• Knowledge of clinical trial processes, GCP, and regulatory requirements
• Strong attention to detail and organizational skills
• Ability to work independently and manage multiple tasks effectively
• Excellent analytical and problem-solving abilities
• Proficiency with Microsoft Office Suite and clinical trial management systems (CTMS)
• Willingness to travel for site monitoring visits
• Strong written and verbal communication skills
• Ability to build and maintain strong working relationships with study sites and team members

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