What does a study coordinator do?

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.
Study coordinator responsibilities
Here are examples of responsibilities from real study coordinator resumes:
- Manage and analyze EKG and sleep data collect from subjects in confidential database.
- Establish and maintain strong community partnerships to achieve HIV prevention objectives.
- Conduct consent discussions and other study procedures per protocol and CFR and GCP guidelines.
- Maintain strict patient confidentiality according to HIPPA regulations, GCP and ICH , 21 CFR and other regulatory documentation.
- Maintain accurate IRB, regulatory and study documentation to insure compliance with protocol and good clinical practice guidelines.
- Coordinate day-to-day study activities including data collection and statistical analysis, protocol development/implementation, IRB relations, and staff development.
- Coordinate and conduct pharmaceutical clinical research studies, working collaboratively with patients, pharmaceutical companies, institutional review boards and physicians.
- Participate in NIH monthly training meetings.
- Provide quarterly reports to the NIH.
- Coordinate and monitor regulatory procedures for clinical research per FDA standards.
- Maintain regulatory binders and study documentation in accordance with FDA regulations.
- Develop and write individual protocols, establish research procedures, develop and maintain breast oncology group databases.
- Educate patients on medical procedures and detail requirements while organizing and coordinating medical research to bring new pharmaceuticals to market.
- Prepare monitoring plan and approve IVRS specifications.
- Research current medical research requirements and laws, specifically HIPPA requirements.
Study coordinator skills and personality traits
We calculated that 14% of Study Coordinators are proficient in Patients, Informed Consent, and IRB. They’re also known for soft skills such as Communication skills, Interpersonal skills, and Leadership skills.
We break down the percentage of Study Coordinators that have these skills listed on their resume here:
- Patients, 14%
Coordinated and conducted pharmaceutical clinical research studies, working collaboratively with patients, pharmaceutical companies, institutional review boards and physicians.
- Informed Consent, 9%
Coordinated visits including proper recording of medical histories, eligibility criteria, and informed consent.
- IRB, 7%
Coordinated day-to-day study activities including data collection and statistical analysis, protocol development/implementation, IRB relations, and staff development.
- Data Collection, 5%
Performed patient eligibility evaluations, registrations, data collection, query resolution, and completed routine internal quality control audits.
- FDA, 5%
Maintained all required documentation for the Study protocol and for FDA regulations ensuring accurate completion of all technical requirements.
- Clinical Trials, 4%
Recognized by sponsoring agencies for clinical trial recruitment and enrollment success, protocol adherence, data integrity, and effective communication.
Most study coordinators use their skills in "patients," "informed consent," and "irb" to do their jobs. You can find more detail on essential study coordinator responsibilities here:
Communication skills. To carry out their duties, the most important skill for a study coordinator 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." Study coordinators often use communication skills in their day-to-day job, as shown by this real resume: "coordinated communication, meetings, and travel between all consortium sites and coordinating center actively involved in ide submissions to fda"
Interpersonal skills. Another soft skill that's essential for fulfilling study coordinator duties is interpersonal skills. The role rewards competence in this skill because "natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals." According to a study coordinator resume, here's how study coordinators can utilize interpersonal skills in their job responsibilities: "demonstrated excellent interpersonal skills ensuring smooth collaboration with cros, quintiles, rps & inventive health. "
Leadership skills. This is an important skill for study coordinators to perform their duties. For an example of how study coordinator 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 study coordinator: "developed expertise with project management systems utilized within clinical trials and provided leadership and guidance to others utilizing these systems. ".
Problem-solving skills. study coordinator responsibilities often require "problem-solving skills." The duties that rely on this skill are shown by the fact that "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." This resume example shows what study coordinators do with problem-solving skills on a typical day: "performed pharmacovigilance by reporting all adverse events of test articles and procedures in accordance with the fda and ensure proper resolution. "
Time-management skills. Another common skill required for study coordinator responsibilities is "time-management skills." This skill comes up in the duties of study coordinators all the time, as "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." An excerpt from a real study coordinator resume shows how this skill is central to what a study coordinator does: "support at site ensuring patient recruitment according to protocol and completion on time of ecrf. "
The three companies that hire the most study coordinators are:
- CVS Health16 study coordinators jobs
- University of Rochester15 study coordinators jobs
- University of Washington13 study coordinators jobs
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Study coordinator vs. Research nurse
A research nurse specializes in conducting studies and scientific research for healthcare and medical development. They may work for medical facilities, private clinics, learning institutions, and government agencies. It is their duty to design research strategies and procedures, gather and analyze samples through various scientific methods, coordinate with other experts, and develop treatment and healthcare plans to optimize patient services and outcomes. Moreover, a research nurse typically works with a team of researchers, which requires an active communication line while adhering to the organization's policies and regulations.
While similarities exist, there are also some differences between study coordinators and research nurse. For instance, study coordinator responsibilities require skills such as "clinical trials," "patient care," "excellent interpersonal," and "clinical practice." Whereas a research nurse is skilled in "research projects," "clinical care," "direct patient care," and "patient safety." This is part of what separates the two careers.
Research nurses tend to make the most money working in the pharmaceutical industry, where they earn an average salary of $61,182. In contrast, study coordinators make the biggest average salary, $50,589, in the health care industry.On average, research nurses reach lower levels of education than study coordinators. Research nurses are 5.1% less likely to earn a Master's Degree and 2.2% less likely to graduate with a Doctoral Degree.Study coordinator vs. Clinical research associate
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.
Each career also uses different skills, according to real study coordinator resumes. While study coordinator responsibilities can utilize skills like "research data," "patient care," "institutional review," and "medical history," clinical research associates use skills like "cra," "ich," "site management," and "regulatory submissions."
Clinical research associates may earn a higher salary than study coordinators, but clinical research associates earn the most pay in the pharmaceutical industry with an average salary of $73,702. On the other hand, study coordinators receive higher pay in the health care industry, where they earn an average salary of $50,589.clinical research associates earn similar levels of education than study coordinators in general. They're 0.7% less likely to graduate with a Master's Degree and 2.2% more likely to earn a Doctoral Degree.Study coordinator vs. Clinical research assistant
Clinical research assistants are responsible for assisting with scientific studies and monitoring clinical trials. Other duties and responsibilities include ensuring compliance with clinical trial procedures and protocols, finding research subjects, and collecting and analyzing data. In addition, they are responsible for overseeing clinical site activities and preparing documentation, presentation, and correspondence on findings. They are also expected to prepare informed consent for clinical trials and conduct audits on research trials. The skills and qualifications required for this role include a bachelor's degree in psychology, science or related field, previous work experience, and excellent communication skills.
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from study coordinator resumes include skills like "home health," "nursing home," "glp," and "efficacy," whereas a clinical research assistant is more likely to list skills in "research projects," "coordinators," "phlebotomy," and "literature searches. "
Clinical research assistants earn the highest salary when working in the health care industry, where they receive an average salary of $42,184. Comparatively, study coordinators have the highest earning potential in the health care industry, with an average salary of $50,589.When it comes to education, clinical research assistants tend to earn similar degree levels compared to study coordinators. In fact, they're 4.5% less likely to earn a Master's Degree, and 0.8% less likely to graduate with a Doctoral Degree.Study coordinator vs. Clinical research manager
A clinical research manager is responsible for leading a clinical research team in conducting clinical trials for medical purposes. Clinical research managers conduct scientific investigations, following critical methods and procedures within the budget goals and discussed timeframe. They monitor the adequacy of laboratory tools and equipment, request purchase orders, and ensure the authenticity of the materials for the accuracy of findings. A clinical research manager also enforces strict safety standards and protocols during clinical trials to avoid potential hazards and chemical contamination.
Types of study coordinator
Updated January 8, 2025











