Clinical Research Coordinator
A clinical research coordinator manages clinical trials and studies related to human health. They plan, coordinate, and oversee clinical operations to ensure compliance with protocols and overall clinical objectives.
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Sample Job Descriptions for Clinical Research 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
A Junior Clinical Research Coordinator is responsible for supporting clinical trials and studies under the supervision of senior coordinators. The role involves assisting in the planning, management, and execution of research projects within a clinical setting, ensuring compliance with regulatory standards.
Required Skills
- Detail-oriented with strong analytical skills.
- Effective interpersonal and communication skills.
- Time management and the ability to prioritize tasks.
- Problem solving and critical thinking.
- Comfortable with handling confidential information.
- Aptitude for learning new software and protocols quickly.
Qualifications
- Bachelor's degree in life sciences, nursing, public health, or related field.
- Familiarity with clinical research processes and regulatory requirements.
- Ability to multitask and work effectively in a team.
- Strong organizational and communication skills.
- Proficiency in using electronic data capture systems and MS Office.
- Understanding of Good Clinical Practice (GCP) guidelines is a plus.
Responsibilities
- Assist with the coordination of clinical trials and study activities.
- Help with the recruitment, screening and enrollment of study participants.
- Ensure accurate data collection, documentation, and record keeping.
- Coordinate project meetings and facilitate communication between the research team and stakeholders.
- Support the preparation of reports and submissions to regulatory bodies.
- Monitor study participants and report any adverse events to senior staff.
- Maintain strict confidentiality of study participants and adherence to protocol.
- Assist with the management of study supplies and inventory.
Intermediate (2-5 years of experience)
Summary of the Role
The Clinical Research Coordinator is responsible for overseeing clinical trials and ensuring compliance with protocols, regulations, and standard operating procedures. This role involves managing study activities, ensuring data integrity, and facilitating communication between the study team, sponsors, and regulatory bodies. The ideal candidate will have a strong foundation in clinical research procedures and patient care.
Required Skills
- Strong organizational and project management skills.
- Excellent communication and interpersonal skills.
- High attention to detail and accuracy.
- Proficient in data management software and Microsoft Office.
- Ability to multi-task and prioritize in a fast-paced environment.
Qualifications
- Bachelor's degree in a life sciences, nursing, or related field.
- 2-5 years of experience in clinical research coordination or a similar role.
- Knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical trial processes.
- Previous experience with Institutional Review Board (IRB) submissions and regulatory compliance.
Responsibilities
- Coordinate the day-to-day activities of clinical research studies.
- Ensure compliance with study protocols, and monitor participants' health during the trial.
- Manage regulatory documentation and ensure all aspects of the study adhere to ethical standards and regulatory requirements.
- Liaise with medical staff, research investigators, and sponsors to ensure effective communication and problem resolution.
- Oversee data collection, data entry, and ensure the accuracy and confidentiality of participant data.
- Assist with the development of study materials, including informed consent documents, case report forms, and study protocols.
Senior (5+ years of experience)
Summary of the Role
The Clinical Research Coordinator will be responsible for overseeing clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate data. This role requires coordination with multiple stakeholders, including patients, healthcare professionals, and sponsors, to facilitate the successful execution and completion of clinical studies.
Required Skills
- Strong organizational and leadership skills with the ability to handle multiple tasks simultaneously.
- Excellent interpersonal and communication skills, both verbal and written.
- Proficient in data analysis, with a firm grasp of statistical methods and software.
- High level of attention to detail and accuracy.
- Ability to make critical decisions under pressure and problem-solving skills.
Qualifications
- Bachelor's degree in a life science, nursing, or related field required; Master's degree or higher is preferred.
- Certification as a Clinical Research Coordinator (e.g., CCRC, SOCRA) is highly desirable.
- Minimum of 5 years of experience coordinating clinical research studies, including managing complex and large-scale trials.
- Thorough understanding of GCP, ICH guidelines, FDA regulations, and other relevant regulatory standards.
- Experience with Electronic Data Capture (EDC) systems and clinical trial management software.
Responsibilities
- Coordinate and lead the planning, implementation, and execution of clinical trials in accordance with protocols and regulatory guidelines.
- Supervise clinical trial staff and provide guidance on study-related tasks.
- Ensure the protection of study participants by strictly adhering to safety and ethical standards.
- Manage study documentation and maintain detailed and accurate records for the duration of the clinical trial.
- Develop standard operating procedures (SOPs) and ensure that all trial activities are in compliance with these SOPs.
- Communicate regularly with sponsors, investigators, and other stakeholders to provide updates and resolve any issues that may arise.
- Monitor patient recruitment and retention, and implement strategies to achieve target enrollment.
- Prepare for and coordinate site visits from regulatory authorities or sponsors' representatives.
- Analyze data and assist in writing reports, abstracts, and manuscripts for publication.
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