CCRPS

• Get and keep a certification for clinical research coordinators to make sure they are competent and know the relevant regulations. • Develop and carry out protocols for clinical research studies following Good Clinical Practices (GCP) guidelines. • Be responsible for collecting, organizing, analyzing, and reporting data from the study. • Get approval from the Institutional Review Board (IRB) before starting a study. • Find patients for trials, do screening tests, schedule appointments, get their permission, and enroll them in clinical studies. • Look at patients’ medical records to see if they qualify for trials. • Write informed consent documents that meet protocol requirements and regulatory guidelines. • Making sure that clinical research is done according to the approved plan and rules • Working with study sponsors, principal investigators, regulatory agencies, institutional review boards (IRB), and other people to make sure that all protocol requirements are met • Creating and carrying out trial protocols, including data collection and documentation procedures • Getting permission from participants for participation in clinical trials • Finding eligible participants for clinical trials based on inclusion/exclusion criteria • Organizing various aspects of the clinical trial such as scheduling visits and arranging investigative activities • Collecting data from people who are using the thing being tested to see if it is safe and works well. • Writing reports to the person in charge of the test summarizing what has happened so far. • Answering questions from the people funding the test about things that have gone wrong during the clinical trial. • Keeping accurate records of all study-related information such as forms from patients, case report forms, drug accountability logs, lab test results, etc. • Knowing about Good Clinical Practice (GCP) guidelines and local/international laws governing clinical research operations

The average salary of a Clinical Research Coordinator (CRC) can range from $45,000 to $90,000 per year, depending on geographic location, experience and qualifications. Clinical Research Coordinators who obtain certification through organizations such as CCRPS or SOCRA may be able to command higher salaries.

• Excellent communication and interpersonal skills: Clinical Research Coordinators must be able to communicate effectively with all people involved in the research study, including staff, sponsors, and participants. They must also have the ability to build trust and rapport with these individuals. • Strong organizational skills: Clinical Research Coordinators are responsible for organizing and managing different aspects of a clinical trial. This includes creating timelines, setting budgets, recruiting participants, scheduling meetings, monitoring progress against milestones, etc. • Knowledge of Good Clinical Practices (GCP): GCP is a set of international ethical principles that govern how a clinical trial is conducted. As a Clinical Research Coordinator, you must have knowledge of GCPs in order to ensure the quality and safety of the data collected during the study. • Regulatory compliance: Clinical Research Coordinators must stay up-to-date on any changes in regulations governing clinical trials. They must be familiar with government regulations such as HIPAA and other laws related to patient privacy and conduct of clinical research studies. • Project Management Skills: Clinical Research Coordinators need solid project management skills to plan and execute duties related to a given study. This can include developing protocols, training staff members on protocol procedures, coordinating site visits by sponsors/monitors etc. • Attention to detail: It is essential for Clinical Research Coordinators to pay attention to detail when conducting data entry or reviewing forms; small errors can lead to inaccuracies in results or discrepancies between paperwork and actual data gathered during the study process. • Computer proficiency: Computers play an integral role in carrying out clinical research activities. Therefore it’s crucial for Clinical Research Coordinators to have good computer proficiency - knowledge of Microsoft Office Suite applications is a plus! • Ability to work independently: Although they may receive guidance from principal investigators or sponsors regarding protocols or procedures while managing various aspects of a study, it’s important for them to be able take initiative when needed and take charge accordingly without constant supervision from others. • Critical Thinking Skills: To evaluate situations quickly and employ problem solving strategies when needed; this allows them propose solutions based on best practices or current standards applicable for the particular situation at hand • Ability To Follow Instructions Correctly: Be able to correctly understand instructions from sponsors/investigators then translate those instructions into actionable tasks efficiently • Understanding Of Statistical Concepts And Data Analysis Techniques : The ability understand statistical concepts related medical terminology; this helps facilitate accurate interpretation of results • Knowledge Of Medical Terminology : Understanding medical terms used during reports associated with studies enables them better understand requirements then allow them provide support more accurately • Experience With Electronic Data Capture Systems : Familiarity working electronic data capture systems often used manage administrative tasks associated with studies; this saves time ensure accuracy completion tasks

•Clinical research coordinators have many different career paths available to them, depending on their education level and experience in the field. • Drug development is a common career path for clinical research coordinators. In this role they would be responsible for coordinating with medical professionals to create and continue trials for new drugs or treatments. • Regulatory affairs is another common career path for clinical research coordinators. In this role they would be responsible for researching applicable regulatory requirements regarding clinical trials and making sure that those standards are met throughout the entire process. • Data management is another highly sought after area of work within this field. Clinical research coordinators who specialize in data management are generally tasked with collecting data from studies conducted by various institutions around the world and organizing it into a cohesive system so that it can be analyzed more easily