Clinical Research Coordinator
Job description
About the role
The owns the complete lifecycle of participant engagement for our clinical trials, managing every touchpoint from initial outreach through final follow-up with meticulous attention to detail. This professional is responsible for maintaining the integrity and efficiency of the participant recruitment funnel, ensuring that metrics are not only tracked but actively analyzed to drive continuous improvement in conversion rates. They act as the primary human interface between the trial and the participant, building trust and providing clear, compassionate guidance throughout the study journey. The role involves vigilant oversight of safety reporting, where any adverse event is documented and escalated with precision to protect participant welfare and regulatory compliance. You will partner closely with scientific and regulatory teams to ensure that all study documentation, including protocols and informed consent forms, is accurate, current, and aligned with current standards. Additionally, this position supports the regulatory submission process, preparing materials for Institutional Review Boards and ensuring that all documentation meets the strictest ethical and legal requirements. Finally, you will contribute to the development of participant-facing materials, ensuring that recruitment and consent documents are clear, accessible, and fully compliant with Good Clinical Practice guidelines to uphold the highest standards of trial quality.
Key facts
What you'll do
Coordinate the end-to-end participant recruitment process, managing outreach, prescreening, eligibility assessment, and informed consent procedures with high reliability.
Maintain dynamic and real-time recruitment metrics dashboards, analyzing trends and bottlenecks to optimize the efficiency of the participant pipeline.
Serve as the central and reliable point of contact for all trial participants, addressing inquiries and providing timely, accurate information regarding study procedures and expectations.
Assist in the systematic capture and reporting of adverse events, ensuring that all safety data is recorded thoroughly and submitted according to established protocols.
Support the creation and maintenance of core clinical study documents, including case report forms, standard operating procedures, study protocols, and informed consent templates.
Facilitate the preparation and submission of regulatory and ethics committee materials, including documentation for IRB review and ongoing compliance tracking.
Develop and refine participant recruitment strategies and educational content, ensuring all materials adhere strictly to Good Clinical Practice guidelines and regulatory requirements.
Perform administrative oversight of study timelines, ensuring that participant scheduling, assessments, and follow-ups are coordinated seamlessly to keep the study on track.
Collaborate with cross-functional teams to gather necessary data and insights, contributing to the overall scientific integrity and operational success of the clinical program.
Ensure that all participant interactions reflect the highest standards of professionalism, empathy, and ethical conduct, reinforcing trust in the research process.
Track and manage study supplies and documentation flow, maintaining organized records that support audit readiness and data transparency.
Provide support during study initiation and close-out activities, including site training materials development and final study reporting tasks.
Monitor recruitment progress against targets, identifying areas where interventions are needed and proposing actionable solutions to the study team.
Assist in the translation of complex study procedures into clear participant instructions, ensuring comprehension and compliance with trial protocols.
Requirements
Hold a Bachelor's degree in a STEM field or a closely related discipline that provides a foundational understanding of scientific principles.
Possess at least 2 years of professional experience in a role that involves direct interaction with clinical trial participants or a similar regulated environment.
Have documented experience in writing clear, accurate, and high-quality clinical documentation, such as protocols, case report forms, or standard operating procedures.
Demonstrate a working knowledge of basic medical terminology and clinical research concepts to effectively communicate with study teams and understand trial designs.
Exhibit strong organizational skills, with the ability to manage multiple tasks, deadlines, and participant schedules in a fast-paced environment without compromising accuracy.
Show a proven history of exceptional contribution in previous roles, where your work has positively impacted team objectives and study outcomes.
Maintain the highest level of integrity and sound professional judgment in all interactions, ensuring confidentiality and compliance with ethical standards.
Be comfortable working within a framework of Good Clinical Practice, regulatory requirements, and institutional review board procedures to ensure the validity and protection of study data.