Clinical Research Coordinator

Working Schedule

• Clinical Research Coordinators typically work full-time. Schedules may vary, with night or weekend work possible.

Typical Duties

• 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

Additional Responsibilities

• 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

Soft Skills

• Adaptability
• Analytical
• Attention to detail
• Collaborative
• Critical thinking
• Curiosity
• Deductive reasoning
• Diligence
• Ethical judgment
• Independence
• Interpersonal and communication skills
• Problem-solving ability
• Strategic planning
• Teamwork
• Time management

Technical Skills

Clinical Research Coordinators need technical skills related to the below:

• Clinical data management systems and software (e.g., Oracle Clinical, Medidata Rave, and SAS)
• Clinical trial management software (e.g., Oracle Clinical, Medidata Rave)
• Data interpretation
• Data privacy and security practices (such as encryption, access controls, and audit trails)
• 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
• Reporting tools (like SPSS and R)
• Statistical analysis
• Working with regulatory agencies

• 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.