Clinical Trials Coordinator

Position Overview

We are seeking a highly organized and detail-oriented Clinical Trials Coordinator to join our dynamic team and play a pivotal role in the execution and management of clinical trials and research initiatives. In this critical position, you will serve as the backbone of our clinical operations, ensuring seamless coordination between investigators, sponsors, and participants while maintaining the highest standards of regulatory compliance and data integrity. Your expertise will be instrumental in advancing medical research and contributing to groundbreaking discoveries that improve patient outcomes.

Key Responsibilities

The Clinical Trials Coordinator will be responsible for a wide range of activities essential to the successful implementation of clinical trials. Your core duties will include:

• Protocol Implementation and Coordination: Oversee the day-to-day operations of clinical trials by ensuring adherence to approved research protocols, institutional guidelines, and regulatory requirements. Act as a liaison between the investigative team, sponsors, and regulatory bodies to facilitate smooth trial execution.
• Documentation and Compliance Management: Maintain meticulous records of all trial-related documentation, including study protocols, informed consent forms, case report forms, regulatory submissions, and participant records. Ensure compliance with Good Clinical Practice (GCP) guidelines, ICH standards, and institutional policies to uphold the integrity and validity of the research.
• Stakeholder Collaboration: Foster strong relationships with principal investigators, clinical research associates, sponsors, contract research organizations (CROs), and other key stakeholders. Facilitate effective communication to resolve issues, address concerns, and ensure alignment on trial objectives and timelines.
• Participant Engagement and Management: Support the recruitment, screening, enrollment, and retention of study participants. Coordinate scheduling for study visits, procedures, and follow-up assessments while ensuring participants receive clear instructions and support throughout the trial. Collect and document high-quality data in compliance with study protocols and regulatory standards.
• Data Collection and Quality Assurance: Assist in the collection, verification, and entry of clinical data into electronic data capture (EDC) systems or other designated platforms. Monitor data for accuracy, completeness, and timeliness, and report any discrepancies or adverse events to the appropriate personnel for resolution.
• Regulatory and Ethical Oversight: Assist in preparing and submitting regulatory documents, including Investigational New Drug (IND) applications, Institutional Review Board (IRB) submissions, and annual reports. Ensure that all trial activities comply with ethical principles, regulatory requirements, and institutional policies.

Qualifications and Experience

To excel in this role, you must possess the following qualifications and experience:

• Education: A Bachelor’s degree in a relevant field such as healthcare, life sciences, clinical research, pharmacy, nursing, or a closely related discipline. Advanced degrees or certifications in clinical research (e.g., CCRP, SOCRA) are a plus.
• Professional Experience: A minimum of three years of hands-on experience in clinical trials, clinical research, or a related healthcare environment. Prior experience in a hospital, research center, or academic medical setting is highly desirable, as it demonstrates familiarity with the complexities of clinical research operations.
• Technical Proficiency: Strong working knowledge of clinical trial management systems (CTMS), electronic data capture (EDC) tools, and Microsoft Office Suite (Word, Excel, PowerPoint). Familiarity with regulatory databases and compliance frameworks is beneficial.
• Soft Skills: Exceptional organizational, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced environment while maintaining attention to detail and a commitment to accuracy. Proficiency in written and verbal English is required; additional language skills are a valuable asset.
• Personal Attributes: A proactive mindset, ethical integrity, and a passion for advancing medical research. Demonstrated ability to work collaboratively in a team-oriented setting while exercising independent judgment when necessary.

If you are a motivated professional with a passion for clinical research and a commitment to excellence, we invite you to apply and become an integral part of our mission to drive innovation in healthcare.