Đèn chiếu điểm
Clinical Coordinator, Clinical Program Coordinator, Clinical Program Manager, Clinical Research Administrator, Clinical Research Coordinator, Clinical Research Manager, Clinical Research Nurse Coordinator, Clinical Trial Coordinator, Clinical Trial Manager, Research Coordinator
It takes several years and vast amounts of expensive research and development (R&D) to bring a new medical drug to market. This R&D is done at research sites where teams of experts are assigned to conduct trials and collect data to determine if a drug is effective and safe. At the heart of such operations are a principal investigator and a Clinical Research Coordinator (aka CRC).
CRCs manage several key aspects of the clinical trials process. Collaborating with other researchers and healthcare professionals, they establish trial protocols, recruit volunteers to participate, collect and manage data, prepare detailed documentation, and maintain compliance with regulatory standards.
Through meticulous planning, coordination, and execution of clinical trials, Clinical Research Coordinators help innovative medical solutions receive approval. Thus, their work directly contributes to the development of new treatments and therapies, making a significant impact on the healthcare industry and patient outcomes!
- Playing a pivotal role in the development of new therapies and treatments
- Advancing medical research to improve patient care and outcomes
- Contributing to the body of scientific knowledge in healthcare
Lịch làm việc
- Clinical Research Coordinators typically work full-time. Schedules may vary, with night or weekend work possible.
Nhiệm vụ điển hình
- Oversee clinical trial operations from start to finish
- Collaborate with healthcare professionals and researchers to establish protocols, including administration and data collection guidelines
- Establish realistic goals for each trial phase
- Recruit and screen trial volunteers via interviews and medical record reviews
- Organize suitable study spaces, equipment, and supplies
- Schedule activities that volunteers need to complete
- Order, label, store, and ship collection samples
- Take volunteer vital signs and perform other procedures, as applicable
- Advise on dosage modifications based on unique patient attributes
- Collect, code, and analyze study trial data
- Manage documentation such as progress notes, side effect or adverse event reports, compliance forms, and other records
- Record and report adverse events to oversight agencies
- Ensure compliance with established protocols and regulatory guidelines
- Coordinate funding requests and manage budgets
- Provide support and updates to trial participants
- Support quality assurance evaluations. Address any trial-related problems
- Keep stakeholders updated on the progress
- Work with investigators to consolidate study findings for external presentation
Trách nhiệm bổ sung
- Review research journals and take professional development courses to keep up with advancements
- Train staff on policies and protocols
- Coordinate site visits and manage incoming questions
- Liaise with laboratories and investigators, as needed
- Create and distribute materials to solicit volunteers
- Administer trial medications or issue trial medical devices for participant use
- Share participant figures with statistical centers
Kỹ năng mềm
- Khả năng thích ứng
- Phân tích
- Chú ý đến chi tiết
- Hợp tác
- Tư duy phản biện
- Sự tò mò
- Deductive reasoning
- Siêng năng
- Phán đoán đạo đức
- Độc lập
- Kỹ năng giao tiếp và ứng xử giữa các cá nhân
- Khả năng giải quyết vấn đề
- Lập kế hoạch chiến lược
- Teamwork
- Quản lý thời gian
Kỹ năng kỹ thuật
Clinical Research Coordinators need technical skills related to the below:
- Hệ thống và phần mềm quản lý dữ liệu lâm sàng (ví dụ: Oracle Clinical, Medidata Rave và SAS)
- Clinical trial management software (e.g., Oracle Clinical, Medidata Rave)
- Giải thích dữ liệu
- Thực hành bảo mật và quyền riêng tư dữ liệu (như mã hóa, kiểm soát truy cập và theo dõi kiểm toán)
- Electronic health records
- Healthcare regulations and compliance standards
- Institutional Review Board submissions
- Knowledge of Good Clinical Practice guidelines
- Medical terminology and clinical procedures understanding
Project management - Regulatory compliance and documentation
- Các công cụ báo cáo (như SPSS và R)
- Phân tích thống kê
- Làm việc với các cơ quan quản lý
- Academic research institutions
- Biotechnology firms
- Contract research organizations
- Government health agencies
- Pharmaceutical companies
Clinical Research Coordinators should love research and be committed to developing more effective interventions such as pharmaceuticals and medical technologies.
Their work demands vigilance, precision, and the ability to manage complex logistics. But these professionals don’t just deal with equipment and data. They’re dealing with real patients who volunteered to be part of an experimental testing process! Oversights or errors could put volunteers at risk, so clinical trials must be conducted efficiently, ethically, and with special attention to participant safety.
The world of clinical research is embracing technological advancements like electronic data capture systems to streamline data collection and management, reducing errors and speeding up analysis times.
The use of real-world data and real-world evidence is revolutionizing study designs and providing deeper insights into treatment effectiveness and safety in real-world settings.
The trend of personalized medicine is also impacting clinical research due to its focus on targeted therapies based on individual genetic profiles. This requires more intricate study designs and specialized coordination but can lead to better patient outcomes and care paradigms.
Individuals attracted to this career likely had a keen interest in science and health from an early age. They may have enjoyed science fairs, running STEM-related experiments at home, or volunteering in healthcare settings.
- Clinical Research Coordinators usually need a bachelor’s degree in biology, nursing, public health, health sciences, microbiology, or a related area
○ In addition, relevant work experience in clinical research or healthcare is required
○ Many positions require a thorough background check that may include criminal history, employment history, drug screening, and a credit check
- Common college courses include:
○ Biomedical Ethics
○ Biostatistics
○ Clinical Data Management
○ Clinical Research Methods
○ Clinical Trial Design and Implementation
○ Epidemiology
○ Ethics in Clinical Research
○ Good Clinical Practice Guidelines
○ Health Economics and Outcomes Research
○ Patient Recruitment and Retention Strategies
○ Pharmacology
○ Quality Assurance in Clinical Research
○ Regulatory Affairs
○ Risk Management in Clinical Trials
- A popular, optional certification is the Association of Clinical Research Professionals’ Certified Clinical Research Coordinator (CCRC)
○ To sit for the CCRC exam, applicants need either:
◘ 3,000 hours of verifiable work experience related to human subject research, or;
◘ 1,500 hours of verifiable work experience and a clinical research degree from a CHEA-accredited institution
○ Other Association of Clinical Research Professionals credentials include:
◘ Certified Clinical Research Associate
◘ Certified Principal Investigator
- Optional certifications from other organizations include:
○ Society of Clinical Research Associates - Certified Clinical Research Professional
○ Public Responsibility in Medicine and Research - Certified IRB Professional
○ Research Administrators Certification Council - Certified Pre-Award Research Administrator
○ Research Administrators Certification Council - Certified Research Administrator
- Not all Clinical Research Coordinators hold a bachelor’s degree, but at least 60% do.
- Look for programs featuring:
○ Curricula that offer comprehensive coverage of clinical research principles;
○ Internship opportunities with hospitals, research institutions, or pharmaceutical companies;
○ Faculty with real-world experience in clinical trials and research;
○ High-quality facilities with the latest research tools and technologies;
○ Connections with the clinical research industry for potential employment opportunities!
- Consider the program's cost and the availability of financial aid or scholarships.
- Focus on STEM courses, especially biology, human anatomy and physiology, microbiology, genetics, chemistry, organic chemistry, biochemistry, algebra, geometry, pre-calculus or calculus, statistics, physics, health sciences, biotechnology, computer science, data science, and psychology
- Knock out Advanced Placement courses to prepare for college
- Participate in science clubs, fairs, and research projects, particularly ones that may involve statistical software and data analysis
- Get a feel for the subject matter through short introductory courses via Coursera, Udemy, edX, and other sites
- Volunteer or seek part-time work in healthcare settings to understand patient care
- Engage in internships or job-shadowing opportunities in clinical research settings
- Follow clinical research news, blogs, and journals to stay informed on industry trends
- Network with professionals in the field for guidance and mentorship
- Lưu lại những thành tích, dự án và kỹ năng của bạn vào sơ yếu lý lịch
- Decide who you want to serve as your references. Ask for their permission to give out their contact information
- Hãy đến trung tâm hướng nghiệp của trường để được hỗ trợ chuẩn bị sơ yếu lý lịch và thực hiện các buổi phỏng vấn thử
- Apply for entry-level positions, volunteer roles, internships, work placements, or clinical research apprenticeships to gain real-world experience
- Review job postings on Indeed, Glassdoor, and other portals
- Note the keywords in job ads. Try to incorporate them into your resume where possible
- Common keywords might include:
○ Adverse Event Reporting
○ Budget Management
○ Clinical Protocols
○ Clinical Research
○ Clinical Trial Management Systems
○ Data Collection Methods
○ Electronic Data Capture Systems
○ Ethical Standards
○ Informed Consent Process
○ IRB Submissions
○ Patient Screening
○ Pharmacovigilance (i.e., drug safety)
○ Protocol Development
○ Quality Assurance
○ Regulatory Compliance
○ Study Design and Implementation
- Take a look at the Clinical Research Coordinator resume templates for ideas
- Review Clinical Research Coordinator interview questions such as “Have you ever made a mistake with entering data into a database? How did you realize it, and what did you do to correct it?”
- Practice your replies in mock interviews with friends
- Be familiar with the clinical research technologies, terminology, and trends
- Dress appropriately for interviews!
- Seek advice from mentors and supervisors about career progression
- Continue learning through professional development courses or by earning certifications like the Association of Clinical Research Professionals’ Certified Principal Investigator
- Consider knocking out a graduate degree
- Volunteer to take on more complex simulation projects and leadership roles
- Build relationships with fellow researchers and healthcare professionals
- Specialize in an emerging area of clinical research like gene therapy
- Stay active in professional organizations such as the Association of Clinical Research Professionals
- Contribute to forums, blogs, and journals. Present at seminars and conferences
- Nếu cần thăng tiến, hãy cân nhắc việc di chuyển để tìm kiếm việc làm tại các tổ chức lớn hơn
Trang web
- Hiệp hội Quản lý Thông tin Y tế Hoa Kỳ
- Hiệp hội Tin học Y khoa Hoa Kỳ
- Hiệp hội Thống kê Hoa Kỳ - Ban Dược phẩm sinh học
- Association of Clinical Research Professionals
- Hiệp hội các nhà phân tích chăm sóc sức khỏe chuyên nghiệp
- Biocomplexity Institute of Virginia Tech
- Tin sinh học
- BioInformatics Inc.
- Hiệp hội Tiêu chuẩn Trao đổi Dữ liệu Lâm sàng
- Nghiên cứu lâm sàng: Truy cập mở
- Clinical Research Society
- Thử nghiệm lâm sàng
- ClinicalTrials.gov
- Ủy ban công nhận về giáo dục quản lý thông tin và tin học y tế
- Genedata
- Hiệp hội chăm sóc sức khỏe và phân tích dữ liệu
- Hiệp hội Hệ thống Quản lý và Thông tin Chăm sóc Sức khỏe
- Khoa học dữ liệu sức khỏe
- HLA Informatics Group
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- International Society for Computational Biology
- Hiệp hội quốc tế về nghiên cứu kinh tế dược và kết quả
- Hiệp hội Thống kê sinh học lâm sàng quốc tế
- Tạp chí nghiên cứu tiền lâm sàng và lâm sàng
- Tạp chí của Hiệp hội Quản lý Dữ liệu Lâm sàng
- Mathematical Biosciences Institute
- Hiệp hội các tổ chức dữ liệu y tế quốc gia
- National Center for Biotechnology Information
- National Center for Genome Resources
- Hiệp hội chăm sóc sức khỏe quốc gia
- National Institute of General Medical Sciences
- National Institutes of Health
- NIH Intramural Research Program
- Open Bioinformatics Foundation
- Quan điểm trong nghiên cứu lâm sàng
- Project Management Institute
- Qlucore
- Seqera Labs
- Hiệp hội quản lý dữ liệu lâm sàng
- Society of Clinical Research Associates
- Hiệp hội thử nghiệm lâm sàng
- Strand Life Sciences
- Translational Genomics Research Institute
- Thử nghiệm
Sách
- Essential Concepts in Clinical Research: Randomised Controlled Trials and Observational Epidemiology, by Kenneth Schulz PhD and David Grimes MD
- Foundations of Clinical Research: Applications to Evidence-Based Practice, by Leslie Portney DPT PhD
- Principles and Practice of Clinical Research, by John Gallin MD (Editor), et. al.
Clinical Research Coordinators are essential to the process of conducting medical trials, but there is a limited number of positions available at any given time. If you’re interested in exploring some alternative career paths, consider the following options:
- Nhà thống kê sinh học
- Clinical Data Manager
- Clinical Nurse Specialist
- Data Manager for Clinical Research
- Health Informatics Specialist
- Health Specialties Teacher
- Medical and Clinical Laboratory Technologists
- Quản lý dịch vụ y tế và sức khỏe
- Nhà khoa học y tế
- Medical Writer
- Natural Sciences Manager
- Pharmaceutical Sales Representative
- Public Health Analyst
- Quality Assurance Analyst
- Regulatory Affairs Specialist
- Nhà khoa học nghiên cứu
- Social Science Research Assistant
- Water Resource Specialist
Nguồn cấp tin tức
Việc làm nổi bật
Các khóa học và công cụ trực tuyến
Kỳ vọng về mức lương hàng năm
Người lao động mới bắt đầu với mức lương khoảng 45.000 đô la. Mức lương trung bình là 60.000 đô la mỗi năm. Người lao động có nhiều kinh nghiệm có thể kiếm được khoảng 78.000 đô la.