Clinical Study Coordinator Job Description [Updated for 2025]

In the evolving field of healthcare, the role of Clinical Study Coordinators is becoming increasingly critical.

As medical research advances, the need for competent professionals who can facilitate, monitor and manage clinical trials grows exponentially.

But what exactly does a Clinical Study Coordinator do?

Whether you are:

• A job seeker trying to understand the intricacies of this role,
• A hiring manager aiming to delineate the perfect candidate,
• Or simply fascinated by the dynamics of clinical research coordination,

You’ve come to the right place.

Today, we provide a customizable Clinical Study Coordinator job description template, designed for effortless posting on job boards or career websites.

Let’s dive right into it.

Clinical Study Coordinator Duties and Responsibilities

Clinical Study Coordinators (also known as Clinical Research Coordinators) oversee the daily operations of clinical trials.

They are responsible for ensuring that the study is conducted in accordance with the study protocol, standard operating procedures, good clinical practice, and the applicable regulatory requirements.

The duties and responsibilities of a Clinical Study Coordinator include:

• Coordinating and managing the daily operations of clinical trials
• Developing and implementing protocols for clinical studies
• Screening and enrolling eligible study participants and ensuring they understand the study protocol
• Monitoring and documenting patients’ responses to treatments and updating patient records
• Performing data collection, entry, and validation
• Ensuring compliance with study protocol, regulatory requirements, and good clinical practice guidelines
• Communicating with the ethics committee, study sponsors, and investigators
• Managing and reporting adverse events and serious adverse events
• Preparing study-related documentation, such as informed consent forms, case report forms, and protocol amendments
• Coordinating and attending study meetings and training sessions
• Ensuring the protection of patients’ rights and confidentiality

 

Clinical Study Coordinator Job Description Template

Job Brief

We are seeking an organized and competent Clinical Study Coordinator to plan and oversee all aspects of our clinical trials.

Responsibilities include coordinating and monitoring study activities, recruiting and consenting participants, ensuring compliance with protocols, and maintaining detailed records of study activity.

The ideal candidate will have a background in life sciences and good knowledge of research methods.

They will be detail-oriented, have strong communication skills, and be committed to protecting the rights, safety and well-being of all study participants.

 

Responsibilities

• Coordinate and execute a variety of clinical research studies in accordance with study protocols
• Recruit, screen and consent study participants
• Collect, process and maintain patient and research data in accordance with regulatory standards
• Coordinate study-related procedures, tests and visits for study participants
• Assist in the preparation and submission of regulatory documents
• Monitor study activities to ensure compliance with protocols and all relevant local, federal, and international regulations
• Coordinate and manage study supplies and equipment
• Prepare progress reports for study investigators and sponsors
• Maintain strict confidentiality and comply with all HIPAA regulations

 

Qualifications

• Bachelor’s degree in life sciences or related field
• Previous experience in clinical research coordination
• Knowledge of federal and local regulations and policies pertinent to research involving human subjects
• Excellent organizational and communication skills
• Proficiency in data management programs and computer skills
• Certification as a Clinical Research Coordinator (CCRC) is preferred
• Ability to manage multiple priorities and projects while working as part of a team

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Clinical Study Coordinator
• Work Environment: Clinical or hospital setting with some remote work possible. Some travel may be required for study-related activities.
• Reporting Structure: Reports to the Clinical Research Manager or Principal Investigator.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $45,000 minimum to $75,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Clinical Study Coordinator Do?

Clinical Study Coordinators, also known as Clinical Research Coordinators, are integral members of the medical research team.

They are typically employed by hospitals, medical research institutions, or pharmaceutical companies.

They oversee the daily operations of clinical trials and studies, ensuring that each phase is conducted in accordance with regulatory standards and protocols.

This includes managing the recruitment and enrollment of study participants, conducting pre-screening interviews, and ensuring informed consent is obtained.

Clinical Study Coordinators also monitor the health and safety of study participants, coordinate and schedule study visits and procedures, and collect, process, and manage patient data and study documents.

They act as liaisons between the clinical site and the study sponsor, maintaining regular communication and reporting any adverse events or study deviations.

They may also assist in the development of study protocols, case report forms, and other study-related documents.

It is their responsibility to ensure that the clinical trial is ethical, safe, and accurate, and they play a crucial role in advancing medical knowledge and patient care.

 

Clinical Study Coordinator Qualifications and Skills

A Clinical Study Coordinator should have the skills and qualifications that align with the responsibilities of the job role, such as:

• Strong knowledge of clinical research processes and medical terminology to understand the study requirements and coordinate the research effectively.
• Excellent organizational and planning skills to manage multiple studies, keep track of study progress, and ensure all research activities are carried out as per schedule.
• Exceptional communication skills to liaise with clinicians, researchers, and patients, clearly explaining study protocols, and addressing any questions or concerns that may arise.
• Good interpersonal skills to work effectively with various stakeholders including patients, medical professionals, and research team members.
• Attention to detail to ensure accurate data collection, record-keeping, and reporting in compliance with regulatory standards.
• Problem-solving skills to quickly identify and address issues that could potentially impact the progress of the study.
• Understanding of ethical guidelines and regulations related to clinical research to ensure studies are conducted ethically and legally.
• Ability to cope with stressful situations and high-pressure deadlines, showing resilience and adaptability.

 

Clinical Study Coordinator Experience Requirements

Clinical Study Coordinators are typically expected to have at least 2 to 3 years of experience in a clinical research setting.

This experience may be gained through roles such as Clinical Research Assistant or Clinical Research Associate.

In these roles, individuals gain experience in areas such as patient recruitment, data management, and regulatory compliance, all of which are essential to the role of Clinical Study Coordinator.

Further, it is common for Clinical Study Coordinators to have experience in coordinating clinical trials, including ensuring the appropriate consents are obtained, managing study documentation, and overseeing the progress of the study.

Candidates with more than 5 years of experience in clinical research and study coordination may be considered for senior or supervisory roles.

This often includes experience in managing multiple clinical trials simultaneously and leading teams.

Additional experience in specific therapeutic areas or with certain types of trials (e.g., Phase I-IV, device trials) may also be beneficial or required for certain Clinical Study Coordinator roles.

Similarly, experience with specific clinical trial software or electronic data capture systems may be advantageous.

Moreover, some roles may require or prefer Clinical Study Coordinators to have a nursing or medical background, further adding to their practical experience in the clinical field.

 

Clinical Study Coordinator Education and Training Requirements

Clinical Study Coordinators typically require a bachelor’s degree in a health-related field such as nursing, biology, or public health.

Some coordinators may hold a master’s degree in a relevant discipline, such as clinical research or health administration.

Training in clinical research practices, legal and ethical issues in human subjects research, and the principles of good clinical practice (GCP) are also essential for this role.

Many universities offer certificate programs in clinical research coordination that cover these topics.

In terms of certification, becoming a Certified Clinical Research Coordinator (CCRC) is highly desirable.

The Association of Clinical Research Professionals offers this certification, which requires a minimum of two years of experience in clinical research coordination and a passing score on an examination.

Clinical Study Coordinators also need to have strong organizational and communication skills, as well as a sound understanding of medical terminology.

Additionally, experience in patient care or medical research can be beneficial.

Continuing education is important in this field to stay updated with the latest research methodologies and ethical guidelines.

 

Clinical Study Coordinator Salary Expectations

The average salary for a Clinical Study Coordinator is approximately $60,088 (USD) per year.

However, the actual earnings can differ based on factors such as the level of experience, qualifications, geographical location, and the specific healthcare facility.

 

Clinical Study Coordinator Job Description FAQs

What skills does a Clinical Study Coordinator need?

Clinical Study Coordinators need excellent organizational and project management skills to manage multiple studies at a time.

They should have strong communication and interpersonal skills for liaising between patients, research teams, and stakeholders.

In addition, they must have a good understanding of medical terminologies, research methodologies, and ethical guidelines.

 

Do Clinical Study Coordinators need a degree?

Yes, Clinical Study Coordinators generally need a bachelor’s degree in a health-related field.

Some roles may require a master’s degree or specific certifications.

In many cases, employers prefer candidates with a background in nursing or clinical research.

 

What should you look for in a Clinical Study Coordinator’s resume?

A Clinical Study Coordinator’s resume should demonstrate a strong background in clinical research.

It should also display their experience in managing and coordinating clinical studies, working with research teams, patient recruitment, ethical compliance, and data management.

Any additional certifications related to clinical research or project management would be a plus.

 

What qualities make a good Clinical Study Coordinator?

A good Clinical Study Coordinator is highly organized, detail-oriented, and able to manage multiple tasks and deadlines.

They should also possess a strong ethical compass and empathy to deal with patients effectively.

Moreover, they should be good team players and have the ability to communicate complex medical information in a simple, understandable manner to various stakeholders.

 

What are the daily duties of a Clinical Study Coordinator?

On a typical day, a Clinical Study Coordinator may be involved in planning and coordinating clinical trials, recruiting and screening participants, collecting and managing patient data, ensuring compliance with ethical guidelines, liaising with research staff, doctors, and patients, and reporting study results to stakeholders.

 

Is it difficult to hire Clinical Study Coordinators?

Hiring Clinical Study Coordinators can be challenging as the role requires a unique combination of skills and experience.

It requires a candidate with a strong clinical background, project management skills, and an understanding of research ethics.

Therefore, finding candidates who meet all these requirements can be demanding.

 

Conclusion

So there you have it.

Today, we’ve given you an inside look at what it truly entails to be a Clinical Study Coordinator.

And guess what?

It’s not just about managing research protocols.

It’s about shaping the future of healthcare, one clinical study at a time.

With our comprehensive Clinical Study Coordinator job description template and real-world examples, you’re fully equipped to take the next step.

But why end your journey here?

Go further with our job description generator. It’s your next step towards creating meticulously detailed job listings or refining your resume to excellence.

Remember:

Every clinical study contributes to a larger healthcare advancement.

Let’s shape that future. Together.

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