What does a Clinical Research Associate do?

A clinical research associate is responsible for assisting medical professionals in clinical trials and conducting research studies on medications and medical procedures. Clinical research associates monitor the research materials, ensuring its safety and reliability through trial procedures, writing comprehensive reports of results, and disseminating information across the concerned parties. They also provide recommendations on improving clinical processes, reiterating protocol requirements, and maintaining strict confidentiality of the trial subjects. A clinical research associate must have extensive knowledge of the medical industry, including its disciplines and principles, to perform duties accurately under minimal supervision.
Clinical research associate responsibilities
Here are examples of responsibilities from real clinical research associate resumes:
- Manage, schedule and train up to 15 CRAs.
- Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
- Manage site TMF to ensure communication requirements adherence
- Manage CRO and regional monitor to complete close out activities, including device accountability management.
- Manage regional academic and community base oncology practices as the primary contact for all communications and support.
- Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
- Study regulatory document (ICF, HIPAA) development/writing/editing/revising/resolution/implementation/correspondence for the IRB process.
- Assist oncology clinical research coordinators by copying medical records of research subjects per institutional protocols.
- Interact with IRB officials, project management and investigators to ensure compliance and accuracy of documentation.
- Provide project management and oversight of pharmaceutical company sponsor clinical research trials conduct in physician office.
- Perform complex clinical services, including phlebotomy, vital signs, specimen processing/shipping and administering of health questionnaires.
- Perform all preliminary diagnostic procedures including the intake and recording of vital signs, electrocardiograms, and phlebotomy.
- Ensure protection of study patients by verifying that inform consent procedures and protocol requirements adhere to applicable regulatory requirements.
- Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and ICH guidelines.
- Perform investigative site file reconciliation and review essential documents for accuracy, consistency and compliance with ICH guidelines and sponsor requirements.
Clinical research associate skills and personality traits
We calculated that 9% of Clinical Research Associates are proficient in Patients, Informed Consent, and CRA. They’re also known for soft skills such as Communication skills, Interpersonal skills, and Leadership skills.
We break down the percentage of Clinical Research Associates that have these skills listed on their resume here:
- Patients, 9%
Chart review of patients undergoing angioplasty procedures or other admitting diagnoses at the MedStar Washington Hospital Center per current review requirements/request.
- Informed Consent, 7%
Proofread FDA /Informed Consent Forms and collected soft copies of personnel certifications/disclosure agreements while maintaining all documentation within the company database.
- CRA, 6%
Served as a CRA with provider of outsourced development services to pharmaceutical and biotechnology industries.
- Clinical Trials, 6%
Support the site identification process and evaluate potential qualified investigators and clinical sites for suitability to participate in the clinical trials.
- Clinical Trial Management, 5%
Maintain clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor.
- Oncology, 4%
Develop and implement research policies and procedures and provide in-service training presentations to the Pediatric Hematology/Oncology nursing staff to ensure compliance.
"patients," "informed consent," and "cra" are among the most common skills that clinical research associates use at work. You can find even more clinical research associate responsibilities below, including:
Communication skills. To carry out their duties, the most important skill for a clinical research associate to have is communication skills. Their role and responsibilities require that "natural sciences managers must be able to communicate clearly with a variety of audiences, such as scientists, policymakers, and the public." Clinical research associates often use communication skills in their day-to-day job, as shown by this real resume: "conducted written and verbal communications with fda reviewers as needed: study close-out visits at sites and preparation for fda inspections. "
Interpersonal skills. Many clinical research associate duties rely on interpersonal skills. "natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals," so a clinical research associate will need this skill often in their role. This resume example is just one of many ways clinical research associate responsibilities rely on interpersonal skills: "maintained a strong positive rapport with study sites and demonstrated exceptional interpersonal skills. "
Leadership skills. This is an important skill for clinical research associates to perform their duties. For an example of how clinical research associate responsibilities depend on this skill, consider that "natural sciences managers must be able to organize, direct, and motivate others." This excerpt from a resume also shows how vital it is to everyday roles and responsibilities of a clinical research associate: "key responsibilities: assumed the following formal leadership roles: mentor, visit leader and interviewer of cra employment candidates. ".
Problem-solving skills. For certain clinical research associate responsibilities to be completed, the job requires competence in "problem-solving skills." The day-to-day duties of a clinical research associate rely on this skill, as "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." For example, this snippet was taken directly from a resume about how this skill applies to what clinical research associates do: "assisted with resolution of data queries - participated in 2 fda audits with successful results. "
Time-management skills. Another crucial skill for a clinical research associate to carry out their responsibilities is "time-management skills." A big part of what clinical research associates relies on this skill, since "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." How this skill relates to clinical research associate duties can be seen in an example from a clinical research associate resume snippet: "work under strict deadlines for conducting studies and submitting validating paperwork to the fda. "
The three companies that hire the most clinical research associates are:
- Laboratory Corporation of America Holdings121 clinical research associates jobs
- QuintilesIMS104 clinical research associates jobs
- Pharmaceutical Product Development
61 clinical research associates jobs
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Clinical research associate vs. Study director
Technically, a study director carries out scientific responsibilities for protocol design or study plan and approval. Study directors supervise the gathering, analysis, interpretation, documentation, and reporting of data results. They handle the matriculation of students with regard to data management system development. Working with the computer systems team is part of their duties so they will be able to establish a data management system in tracking the study participants. They also support the toxicology team or group on different project teams.
While similarities exist, there are also some differences between clinical research associates and study director. For instance, clinical research associate responsibilities require skills such as "patients," "cra," "clinical trials," and "clinical trial management." Whereas a study director is skilled in "toxicology," "study design," "data analysis," and "data interpretation." This is part of what separates the two careers.
Study directors tend to make the most money working in the health care industry, where they earn an average salary of $87,246. In contrast, clinical research associates make the biggest average salary, $73,702, in the pharmaceutical industry.study directors tend to reach similar levels of education than clinical research associates. In fact, study directors are 3.9% more likely to graduate with a Master's Degree and 4.7% more likely to have a Doctoral Degree.Clinical research associate vs. Senior program coordinator
A senior program coordinator is primarily in charge of spearheading and managing programs, ensuring everything runs smoothly and efficiently. Their responsibilities revolve around participating in setting goals and objectives, securing funding and sponsors, overseeing the workforce, and even establishing guidelines. They may also facilitate communication within the company and liaise with external parties. Furthermore, as a senior program coordinator, it is essential to lead and encourage the teams to reach goals, all while implementing the company's policies and regulations, including its vision and mission.
Each career also uses different skills, according to real clinical research associate resumes. While clinical research associate responsibilities can utilize skills like "patients," "cra," "clinical trials," and "clinical trial management," senior program coordinators use skills like "alumni," "excellent organizational," "powerpoint," and "sr."
In general, senior program coordinators achieve similar levels of education than clinical research associates. They're 1.1% more likely to obtain a Master's Degree while being 4.7% less likely to earn a Doctoral Degree.Clinical research associate vs. Laboratory manager
Laboratory managers provide accurate laboratory diagnosis through evaluating specimen procedures and coordinating with pathologists to validate laboratory findings. They are responsible for maintaining laboratory tools and equipment, ensuring the proper sterilization of instruments before and after use, organizing equipment based on its function, and immediately repairing or replacing defective items. A laboratory manager also secures the confidentiality of laboratory systems, keeping records of results, and releasing information to the appropriate personnel. Laboratory managers must have a broad knowledge of the scientific industry, as well as excellent analytical and critical-thinking skills.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a clinical research associate is likely to be skilled in "informed consent," "cra," "clinical trials," and "clinical trial management," while a typical laboratory manager is skilled in "lab equipment," "customer service," "chemistry," and "clinical laboratory."
Laboratory managers earn the best pay in the pharmaceutical industry, where they command an average salary of $90,911. Clinical research associates earn the highest pay from the pharmaceutical industry, with an average salary of $73,702.laboratory managers typically earn similar educational levels compared to clinical research associates. Specifically, they're 4.7% less likely to graduate with a Master's Degree, and 3.1% less likely to earn a Doctoral Degree.Clinical research associate vs. Study coordinator
Study coordinators oversee the entire process of clinical research from its inception to its completion. The coordinators make certain that human subjects are safe and well-protected. They identify the eligibility of the subject through clinical record screening and medical information extracting. It is their responsibility to maintain the regulatory documents based on the requirements of the Food and Drug Administration (FDA). They should develop skills and knowledge in clinical trials, study protocol, and patient care.
Types of clinical research associate
Updated January 8, 2025