Clinical Trial Coordinator
A Clinical Trial Coordinator oversees the administration and implementation of clinical trials, ensuring compliance with protocols, regulatory requirements, and managing patient enrollments and data.
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Sample Job Descriptions for Clinical Trial Coordinator
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
The Clinical Trial Coordinator will support clinical research studies by managing the coordination and administration of trial activities. They will ensure compliance with protocols and overall clinical objectives.
Required Skills
- Strong organizational and communication skills.
- Ability to multitask and manage multiple responsibilities concurrently.
- Detail-oriented with a high degree of accuracy.
- Proficient in Microsoft Office Suite and clinical trial management systems.
Qualifications
- Bachelor's degree in life sciences or related field.
- Prior experience in clinical research is a plus.
- Knowledge of regulatory guidelines and clinical terminology.
- Understanding of Good Clinical Practices (GCP) and International Conference on Harmonisation (ICH) guidelines.
Responsibilities
- Assist in the preparation and management of research protocols and informed consent forms.
- Coordinate the recruitment and consent of study participants.
- Schedule patient visits and ensure accurate documentation and record-keeping.
- Communicate with the clinical research team to ensure trial activities adhere to compliance and regulatory standards.
- Participate in data collection and management, coordinating closely with the data management team.
- Assist with preparing reports and presentations for stakeholder updates.
- Maintain inventory of study supplies and ensure all materials are available as needed for study procedures.
Intermediate (2-5 years of experience)
Summary of the Role
The Clinical Trial Coordinator is responsible for managing and overseeing the daily activities involved in clinical trials. This role ensures that all clinical trials are conducted according to the study protocol, compliance standards, and regulatory requirements. The candidate will serve as a key liaison between clinical investigators, sponsors, and participants.
Required Skills
- Strong organizational and project management skills.
- Excellent communication and interpersonal skills, with an ability to engage effectively with clinical staff, patients, and other stakeholders.
- Detail-oriented with a high degree of accuracy.
- Proficiency in data management software and electronic data capture systems.
- Ability to problem-solve and make decisions quickly.
- Knowledge of medical terminology and the capability to understand and follow study protocols.
Qualifications
- Bachelor's degree in life sciences, nursing, public health, or related field.
- 2-5 years of experience in clinical trial management or related field.
- Certification in clinical research coordination (e.g., SOCRA, ACRP) is preferred.
- Familiarity with Good Clinical Practice (GCP) and relevant regulatory guidelines.
Responsibilities
- Coordinate the daily operations of clinical trials, including patient recruitment, scheduling, data collection, and follow-up.
- Ensure all clinical trial activities comply with regulatory requirements.
- Monitor the progress of clinical trials and provide regular updates to the investigators and sponsors.
- Manage study-related documentation, including consent forms, case report forms, and regulatory submissions.
- Liaise with ethics committees and regulatory bodies to obtain necessary approvals.
- Provide support and education to patients and their families regarding study participation.
- Work with the finance team to manage the trial budget and ensure all financial aspects are handled according to the protocol.
- Resolve any issues that arise during the trial promptly and efficiently.
Senior (5+ years of experience)
Summary of the Role
As a Senior Clinical Trial Coordinator, you will oversee the administration and progress of clinical trials in accordance with protocol guidelines and regulatory requirements. This role involves managing study-related activities, ensuring compliance with Good Clinical Practice (GCP), and maintaining effective communication with stakeholders including sponsors, investigators, and participants.
Required Skills
- Strong leadership and management skills
- Excellent organizational and multitasking abilities
- Effective communication and interpersonal skills
- Proficient in clinical trial management software
- Keen attention to detail and problem-solving aptitude
Qualifications
- Bachelor's degree in life sciences, nursing, or related field
- 5+ years of experience coordinating clinical trials
- Certification in Clinical Research Coordination (e.g., CCRC, ACRP-CP)
- Comprehensive understanding of clinical trial processes and regulatory requirements
- Proven ability to work with cross-functional teams
Responsibilities
- Develop and oversee study protocols and standard operating procedures (SOPs)
- Monitor trial progress to ensure compliance with regulatory standards
- Manage communication with regulatory authorities, sponsors, and ethics committees
- Coordinate and train study staff on trial procedures and documentation
- Ensure patient safety and adherence to study protocol
- Manage the collection, processing, and analysis of study data
- Address and resolve any issues that may arise throughout the trial
- Prepare and submit regular progress reports
- Oversee budgeting and resource allocation for the trial
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