Clinical Research Specialist Job Description

Clinical Research Specialist Job Description, Skills, and Salary

Get to know about the duties, responsibilities, qualifications, and skills requirements of a clinical research specialist. You can use our job description template in this article to produce your own. We also provide you with information about the salary you can earn as a clinical research specialist.

 

Who is a Clinical Research Specialist?

Clinical research specialists are leaders in their area, they develop and manage initiatives that progress health and therapy. Clinical research professionals’ overarching goal is to enhance human health, frequently through clinical research studies. Clinical research professionals often work in offices and laboratories. This is a high-level role that calls for exceptional communication abilities, substantial professional knowledge, the capacity to lead people, and clinical data management and analysis capabilities. In the ever-evolving world of medicine, those who investigate how to become clinical research specialists may find themselves on a fulfilling road.

Specialists in clinical research organize and design clinical studies. Many of the modern scientific breakthroughs depend on what they do. Specialists in clinical research typically collaborate with clinical technicians and interns in laboratories. They may examine data as part of their tasks, compare it to the corpus of existing knowledge, and formulate new ideas. Clinical research professionals work in the medical field and, as their name indicates, handle anything from designing to evaluating new medications. To comprehend how bacteria affect health, researchers also cultivate and examine bacterium cells. You may create protocols and research tools as a clinical research professional, manage research teams, and write reports based on your results. Complex problem-solving, time management, and decision-making abilities are necessary for the position.

 

Conical Research Specialist Job Description

Below are the clinical research specialist job description examples you can use to develop your resume or write a job description for your employee. Employers can also use it to sieve out job seekers when choosing candidates for interviews.

The duties and responsibilities of a clinical research specialist include the following;

  • Coordinate with other researchers, such as study coordinators and research coordinators.
  • Work with patients to inform them of the study’s participation requirements and any possible dangers they could encounter.
  • Monitor medical records to make sure that all data is being collected by the study’s procedure.
  • Assemble research materials for transmission to other locations for future research.
  • Conduct quality control checks on study protocols, devices, and processes, maintaining the integrity of research data.
  • Arrange site inspections to make sure the research is being carried out appropriately and the following procedure.
  • Examine scientific literature to find potential new research ideas.
  • Help to organize clinical studies, including participant recruiting, data gathering, and study follow-up.
  • Collect information from medical records and physical exams to make sure participants satisfy study enrollment requirements.
  • Contribute to grant preparation and writing.
  • Lead recruiting, informed consent, and enrolment of participants;
  • Create posters and oral presentations.
  • Data input, administration, cleansing, modification, and analysis;
  • Create data-gathering instruments.
  • Review patient medical records for data extraction.
  • Submit research as abstracts to conferences, and as complete articles to journals.
  • Study design.
  • Lead primary data gathering.
  • Create and maintain research documentation.
  • Write drug trial techniques (procedures).
  • Select and brief suitable study investigators (clinicians).
  • Set up and disband trial research centers.
  • Create testing materials and provide study sites with adequate amounts.
  • Give physicians guidance on how to perform the studies.
  • Gather and validate data collection forms (also known as case report forms).
  • Monitor progress during the length of the trial.
  • Write reports.

 

Qualifications

  • 5+ years in the domain of clinical research.
  • 5+ years in IRB clinical research application processes.
  • Related expertise in Pharmaceutical/Biotechnology or Contract Research Organization (CRO) is desirable.
  • 5+ years in Phase I, II, III, and IV clinical studies investigator-started trials preferably.
  • Certification in Clinical Research (SOCRA or ACRP) (SOCRA or ACRP).
  • Phlebotomy certification CA is preferable.

 

Essential Skills

  • Regulatory Filings: Regulatory filing is the process of submitting documentation to regulatory bodies, such as the Food and Drug Administration or the Institutional Review Board. This guarantees that research meets all standards and norms for safety and ethics. As a clinical research professional, you may be responsible for ensuring your company’s study conforms to these criteria.
  • Data Collection & Analysis: Data collection and analysis is the process of documenting information on a study’s participants, including their demographics, medical history, health status, and any other characteristics that may be important to the research. Clinical research professionals utilize this data to assess the success or failure of therapies and procedures so they may offer suggestions for future studies. They also evaluate the data to identify if there are any patterns or trends that might help them enhance their processes in the future.
  • Time Management: Time management is the ability to organize and execute work in a manner that guarantees you fulfill deadlines. As a clinical research professional, time management skills are vital since they enable you to finish your job on schedule and ensure projects operate successfully. For example, if you’re working with an external customer that requires information from you by a specific date, it’s crucial to manage your time properly so you can send the needed data before the deadline.
  • Protocol Development: Protocol development is the process through which clinical research professionals build and execute study plans. Protocols are vital because they guarantee that all components of research, including data-gathering techniques, stay constant. This uniformity helps researchers to correctly interpret data and guarantees that individuals get equitable treatment.
  • Attention to Detail: Clinical research professionals must be able to pay strict attention to detail while assessing data, documenting information, and interpreting outcomes. This is because they may need to discover any discrepancies or flaws in the data that might impact the integrity of the research. They also employ their attention to detail while monitoring patient development during the trial time so they can evaluate whether the therapy was beneficial.
  • Organization: The organization may keep track of various activities and commitments. Clinical research professionals employ organizational skills while arranging their work, monitoring data, and reporting outcomes. It’s crucial to be able to manage your time properly so you can finish assignments on time and meet deadlines. You may also need to complete papers or keep records for each project you’re working on.
  • SOP Development: SOPs are the guidelines that clinical research experts follow to maintain uniformity in their work. They construct SOPs for each part of their profession, including how they conduct research, track data, and report findings. Having a good grasp of SOPs helps them to generate these papers fast and properly. It also guarantees that other members of their team understand how to accomplish their tasks.
  • Analytical Skills: Clinical research professionals utilize their analytical abilities to examine data and make educated conclusions regarding the effectiveness of a project. They also examine the safety of new pharmaceuticals by examining possible hazards and benefits for patients who get therapy with the medication and those who do not. Clinical research professionals may also need to assess complicated medical information, such as patient health records or test results, to ensure that all relevant information is included in a study.
  • Vendor Management: A clinical research professional has to know the many suppliers that their organization works with. This involves understanding what each vendor delivers, how much it costs and why a corporation may pick one over another. Having this information enables you to make educated judgments when dealing with suppliers and negotiating contracts. It also helps you learn which providers are ideal for your organization’s requirements.
  • Problem Solving: Problem-solving is the ability to notice and handle difficulties. As a clinical research professional, you may face problems in your job that demand problem-solving abilities. For example, if an experiment isn’t functioning as intended, you may need to troubleshoot to figure out why and how to solve it. This may help you improve procedures and create solutions for future projects.
  • Clinical Trial Management: Clinical research professionals may also need to manage clinical trials, which are investigations that examine the safety and efficacy of novel pharmaceuticals or treatment procedures. They could be responsible for drafting protocols, which are comprehensive instructions on how a study should be run, as well as managing funds, verifying compliance with regulations, and assessing data from completed studies.
  • IRB Submissions: IRB submissions are the paperwork clinical research professionals send to Institutional Review Boards or IRBs. These boards assess and approve research procedures before researchers may begin their investigations. Clinical research experts employ these abilities while making proposals for new research initiatives and continuing current ones. They also guarantee that all of their documentation is in place so they don’t breach any restrictions.
  • Communication: Communication is the capacity to present information in a manner that others can comprehend. Clinical research professionals must be able to interact with their colleagues, supervisors, and clients effectively. This involves being able to explain technical topics in layman’s terms and listening closely to directions from your superiors so you can follow them appropriately.
  • Patient Recruitment: Patient recruitment is the process of obtaining and securing participants for clinical studies. Clinical research professionals generally need to recruit a big number of individuals, thus they may employ many ways to identify volunteers. For example, they could publish adverts on social media or send emails to prospective volunteers. They also need to encourage individuals to engage in their trials, which requires them to explain the relevance of clinical research and offer information on the study.
  • Site Monitoring: Site monitoring is the capacity to analyze a study’s progress and ensure that it continues to accomplish its aims. Clinical research professionals employ site monitoring when they analyze their company’s initiatives, as well as when they collaborate with customers who are conducting studies on their own. This talent demands attention to detail and an ability to spot possible flaws before they become serious problems.
  • Project Management: Project management abilities are vital for clinical research professionals since they typically handle many projects at once. This needs them to have the capacity to prioritize activities, distribute duties and manage deadlines. They also utilize project management software to monitor their work, which needs attention to detail and a grasp of how this software works.

 

How to Become a Clinical Research Specialist

  • Earn a Bachelor’s Degree in a Health-Related Field: The first step to becoming a clinical research expert is to get a bachelor’s degree from an approved institution. The route of study may vary, but degrees relating to health science give a firm starting point. Many persons who earn clinical research specialist positions begin their path with a bachelor’s degree in nursing, health science, biology, or a comparable field. A four-year degree sets the framework for additional education and entry-level experience. It also enhances important abilities that a clinical research expert must learn, such as communication, research and analysis, organization, and the ability to operate as part of a team.
  • Earn a Postgraduate Degree: To develop into a leadership capacity such as a clinical research expert, it is virtually usually essential to get a postgraduate degree. Through advanced study, persons interested in doing clinical research enhance their understanding of implementation and evaluation, and frequently have the chance to use these abilities throughout research stages. For example, an online Master of Science in Nursing equips students with a range of advanced abilities in research, analysis, leadership, and more.
  • Gain Experience in the Field: Many job-seekers who desire to become clinical research experts spend many years in similar occupations, where they gather the necessary expertise. Aspiring professionals sometimes begin their careers in a clinical research assistant job. Working in a research environment under the guidance of an expert gives significant insight that is valuable later on in a clinical research capacity.

 

Where to Work as a Clinical Research Specialist

Clinical research specialists operate in a range of contexts, including hospitals, pharmaceutical businesses, and research organizations. They normally work regular business hours, however, they may be forced to work nights or weekends to fulfill deadlines or attend meetings. Clinical research professionals may also travel to attend conferences or visit other research institutions. The task may be difficult since clinical research professionals must pay strict attention to detail and be able to perform effectively under pressure.

 

Clinical Research Specialist Salary Scale

The average clinical research specialist’s income in the USA is $59,540 per year or $30.53 per hour. Entry-level occupations start at $47,210 per year while most experienced professionals get up to $80,750 per year.

The average clinical research specialist in the United Kingdom is £40,927 per year or £20.99 per hour. Entry-level occupations start at £34,628 per year while most experienced professionals earn up to £55,000 per year.

The average clinical research specialist in Canada is $64,841 per year or $33.25 per hour. Entry-level occupations start at $52,865 per year, while most experienced professionals earn up to $84,377 per year.

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