Clinical Research Associate Job Description: Top Duties and Qualifications

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A Clinical Research Associate, or CRA, is responsible for organizing and overseeing clinical studies or trials to contribute to advances in the medical community. Their duties include contacting individuals to participate in trials, reviewing medical histories of each participant before approval and writing reports to determine the overall success of a new drug, procedure or medical device.

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Clinical Research Associate Duties and Responsibilities

A competent Clinical Research Associate should be able to perform various duties and responsibilities. Proper fulfillment of a Clinical Research Associate’s duties and responsibilities brings success to your company. Clinical Research Associates should assist in organizing and monitoring the different stages of clinical trials. The following are other duties and responsibilities a Clinical Research Associate should be able to execute:

  • Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study
  • Collect and authenticate data collection forms otherwise known as case report forms
  • Screen potential study participants through medical record reviews, interviews and follow-ups with healthcare providers
  • Coordinate with ethics committees to safeguard the rights, safety and wellbeing of all research subjects and research activities
  • Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms
  • Prepare final reports, occasional manuscripts or publication, New Drug Applications (NDAs) and Biological License Applications (BLAs)
  • Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate
  • Oversee research, technical and administrative staff, to include training, hiring, goal setting and distribution of workload

What Does a Clinical Research Associate Do?

Clinical Research Associates typically work for research facilities, clinical agencies and pharmaceutical companies to coordinate clinical trials. They work closely with other clinical research professionals to test new drugs, procedures and biotechnology that could benefit modern medical practices and patient ailments. Their job is to analyze the potential risks of the trial and consult with other professionals to determine what safety protocols to use. 

They may also be responsible for establishing and maintaining relationships with data management facilities to provide study or trial results.

Clinical Research Associate Skills and Qualifications

A Clinical Research Associate will have certain skills and qualifications. Including this category in your description can help you attract a high quality Clinical Research Associate. Skills and Qualifications prove that an individual is capable of performing at a job. Here as some skills and qualifications to look for in your Clinical Research Associate:

  • Strong written and oral communication skills
  • Ability to build effective relationships with trial center colleagues and staff
  • Superior problem solving, deductive reasoning and decision-making skills
  • Good time management and ability to prioritize tasks and accomplish set goals efficiently
  • Knowledge of statistical data collection, validation, editing and analysis techniques
  • Ability to provide technical guidance, advice and support to professional staff where needed
  • Knowledge of laboratory certification processes and standards
  • Excellent attention to detail and ability to maintain detailed and accurate records

Clinical Research Associate Salary Expectations

The national average salary for a Clinical Research Associate is $79,359. This salary is subject to variation depending on size of a company and its geographical location. Before coming up with a favorable salary for your Clinical Research Associate, ensure you confirm with other companies in your location. 

Clinical Research Associate Education and Training Requirements

Education and training requirements are an essential part of your job description. These requirements indicate that a Clinical Research Associate has sufficient knowledge and training to excel at the job. A Clinical Research Associate should have a bachelor’s degree in life sciences such as biochemistry, biology, microbiology and pharmacology. Alternatively, they may have a graduate or a postgraduate degree in medical sciences like immunology, anatomy, physiology and medicine. A Clinical Research Associate may also be proficient with scientific software like InferMed MARCO Electronic Data Capture or StataCorp Stata.

Clinical Research Associate Experience Requirements

A Clinical Research Associate’s experience requirements are necessary to prove their expertise in the profession. A Clinical Research Associate should have extensive experience in clinical data work, clinical laboratory work, nursing, academic or pharmaceutical research and medical sales. They may also have experience serving as clinical coordinators or clinical trials administrators. A Clinical Research Associate should also have experience in dealing with medical research software.

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Frequently asked questions about Clinical Research Associates

 

What is the difference between a Clinical Research Associate and a Clinical Research Coordinator?

The difference between a Clinical Research Associate and a Clinical Research Coordinator is that Clinical Research Coordinators hold more senior positions and a broader scope or responsibilities. For example, Clinical Research Coordinators oversee the process of reviewing applications for clinical trials and have the authority to approve or deny those applicants based on their qualifications. They also determine the budget for the clinical trial and set ethical standards for the trial to promote safety.

In contrast, Clinical Research Associates help Coordinators look through applications and contact qualified applicants to confirm their availability. During the clinical trial, Associates record participants’ reactions to pharmaceutical drugs and assist Coordinators in conducting on-site tests to add to reports later on.

 

What are the daily duties of a Clinical Research Associate?

On a typical day, a Clinical Research Associate reviews their email and voicemail to check for responses from approved participants regarding upcoming clinical trials. They travel from their office to the site of ongoing clinical trials to talk with participants, observe the behaviors and record any changes to their health. Clinical Research Associates also interact with medical professionals to gain their perspective on a pharmaceutical drug or new device. Once back in their office, Clinical Research Associates review their note and add them to an ongoing report for future review and publication.

 

What qualities make a good Clinical Research Associate?

A good Clinical Research Associate has excellent interpersonal communication, enabling them to connect and effectively communicate with people from various backgrounds. Clinical Researchers Associates also need to have excellent written communication to compose reports after each clinical study or trial. They have a passion for medical research, which inspires them to observe clinical trials and compile information highlighting the need for a particular drug or device in medicine. Further, a good Clinical Research Associate should have an ethical mindset. This ensures they uphold safety protocols and advocate for better procedures on behalf of the study participants.

 

Who does a Clinical Research Associate report to?

A Clinical Research Associate typically reports to the Clinical Research Coordinator to organize clinical trials or studies. Clinical Research Associates may also report directly to the Clinical Research Manager or Clinical Research Director in the absence of a Coordinator.

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