Clinical Study Coordinator II – Enterprise

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to advance your career as Clinical Study Coordinator.

COURSE Content

Successfully complete the 8 competency modules below to obtain your VIARES Academy Certificate.

ALCOA-CCEa and source documents

ALCOA-CCEA Principles
Source DocumentsTypes
Correction Methods

Screen Visit

Schedule of Events
Informed Consent Form (ICF)
Informed Consent Process
Elements of an ICF
Medical History
Source Documentation
Concomitant Medication (ConMeds

Baseline Visit

Schedule of Events
Source Documents
Inclusion/Exclusion Criteria
Eligibility
ConMeds
Medical History

Day 2 Visit

Source Documentation
ConMeds
Medical History
Adverse Events (AE) and Serious Adverse Events

Day 3 Visit

Day 3 procedures
New AE/ConMeds
Medical History/AE/ConMeds reconciliation
Protocol Deviations

Day 7 Visit

Day 7 procedures
New AE/ConMeds
Medical History/AE/ConMeds reconciliation
Protocol Deviations

Day 14 Visit

Day 14 procedures
New AE/ConMeds
Medical History/AE/ConMeds reconciliation
Protocol Deviations

Day 28 Visit

Day 28 procedures
New AE/ConMeds
Medical History/AE/ConMeds reconciliation
Protocol Deviations

VIARES CERTIFICATE

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:

course title
contact hours
continuing education units (CEU)
your overall course score
date of completion
personal certificate verification code

We also show you how to best share your certificate on LinkedIn and other social media platforms.

Getting a certification as an advanced clinical study coordinator can provide several benefits, both for your career and for the clinical research industry as a whole. Here are some reasons why you might want to consider getting certified:

Professional credibility: Earning a certification demonstrates your commitment to professionalism and competence in the field of clinical research. Certification can also demonstrate to employers and colleagues that you have a high level of knowledge and expertise in your field.
Career advancement: Certification can increase your marketability and give you a competitive edge in the job market, as well as potentially increasing your earning potential. Many employers may prefer or require certification for advanced clinical study coordinator roles.
Industry recognition: Certification can also contribute to the standardization and recognition of the clinical research profession, helping to establish consistent standards and best practices in the field.
Continuing education: The certification program can help you stay up-to-date on the latest developments in the field and expand your knowledge and skills.
Personal and professional growth: Pursuing certification can be a challenging and rewarding experience, helping you to develop new skills and expand your knowledge, as well as contributing to your personal and professional growth.

Hear from our graduates

Magda

The Viares Clinical Research Academy Talent Program was an exceptional experience! I would never think that online learning can be so well developed and structured. As a person with no monitoring experience, the Academy helped me to

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understand and also built my confidence in the Clinical Research. I feel well prepared to get my first job in this field. Many thanks to Dietmar Eglhofer, the whole team and all amazing tutors who made this program so professional. It was a great opportunity to gain new knowledge and I would recommend it to anyone interested in the field of clinical trials.

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Nadia

VIARES Academy’s flexibility and content lay out are unique for a clinical research program. With practical examples, detailed follow up webinar, it creates reinforcement of modules allowing candidates to strengthen concepts and find real life

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solutions. I learnt so much on drug development, clinical operations & regulatory affairs even after being in academic research for six years and now look forward to build on more industry related skills. Thank you to all the tutors and administration.

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reviews curated by judge.me

WHY BECOME an advanced clinical study coordinator?

There are several reasons why you might consider becoming an advanced clinical study coordinator:

Impact on patient health: As an advanced clinical study coordinator, you would play a critical role in helping to bring new treatments and therapies to patients. By coordinating clinical trials, you would be contributing to the development of potentially life-saving treatments and helping to improve the quality of life for patients.
Career growth and advancement: As an advanced clinical study coordinator, you would have the opportunity to take on more complex and challenging studies, work with a wider range of stakeholders, and develop new skills and expertise. This could lead to career advancement opportunities, such as becoming a project manager or clinical research associate.
Job security: The demand for skilled clinical study coordinators is high, and this is likely to continue as the pharmaceutical industry grows. This means that there is likely to be job security and opportunities for career advancement in this field.
Competitive salary: Advanced clinical study coordinators are typically well-compensated, with salaries that are competitive with other healthcare professions. The salary of an advanced clinical study coordinator can vary depending on a number of factors, such as the location, level of experience, industry, and employer. According to data from the Bureau of Labor Statistics (BLS), the median annual wage for clinical research coordinators, which includes advanced clinical study coordinators, was $53,000 as of May 2020 in the United States. However, salaries can range from around $40,000 to over $80,000 per year, with many coordinators earning in the range of $50,000 to $70,000. Experienced coordinators, those with advanced degrees, or those working in the pharmaceutical industry may earn higher salaries. Overall, the salary of an advanced clinical study coordinator can be competitive, with potential for growth and higher compensation over time as you gain more experience and responsibility.
Flexibility: Many clinical study coordinators work in a variety of settings, including hospitals, research institutions, and pharmaceutical companies. This means that there may be opportunities to work in a setting that is convenient and fits your lifestyle.

Overall, becoming an advanced clinical study coordinator can be a rewarding and fulfilling career path with opportunities for growth, job security, and competitive compensation.

What are typical responsibilities of an advanced clinical study coordinator?

The responsibilities of an advanced clinical study coordinator can vary depending on the organization and the specific clinical trial or study they are working on. However, here are some typical responsibilities you might expect in this role:

Participant recruitment and enrollment: Developing and implementing strategies to recruit and enroll study participants, including advertising, outreach, and communication with potential participants.
Data collection and management: Overseeing the collection and management of study data, including ensuring that data is accurate, complete, and entered into study databases in a timely manner.
Participant communication: Communicating with study participants to provide information about the study, answer questions, and ensure that they are fully informed and comfortable with the study procedures.
Compliance and regulatory oversight: Ensuring that all study procedures are conducted in compliance with regulatory requirements and ethical guidelines, including obtaining informed consent from participants and reporting adverse events.
Study coordination: Coordinating study activities with other members of the study team, including principal investigators, research nurses, and other study coordinators.
Budget and resource management: Managing the study budget and resources, including tracking expenses, coordinating with vendors, and ensuring that the study is conducted within budget.
Quality control and assurance: Conducting regular quality control checks to ensure that the study is conducted according to protocol, and implementing corrective action as needed.
Documentation and reporting: Preparing study reports, including progress reports, safety reports, and final study reports, and ensuring that all documentation is complete and accurate.

Overall, the role of an advanced clinical study coordinator is to manage and coordinate all aspects of clinical studies, from study planning and design to study closeout. Effective coordination and communication with all stakeholders involved in the study, including study participants, principal investigators, and regulatory agencies, is essential to ensure the success of the study.

IS THIS THE BEST OPTION FOR ME?

To become an advanced clinical study coordinator, it’s typically necessary to have a background in a health-related field, such as nursing, pharmacy, or healthcare administration. Here are some of the qualifications and skills that are often required or preferred for this role:

Education: Many advanced clinical study coordinator positions require at least a bachelor’s degree, and some may require a master’s degree in a health-related field.
Experience: Previous experience in clinical research, healthcare administration, or a related field is typically preferred for advanced clinical study coordinator positions. This could include experience working as a clinical research coordinator or research assistant, or experience in healthcare project management.
Knowledge of regulations: Advanced clinical study coordinators must have a thorough understanding of the regulatory requirements for clinical research, including FDA regulations and International Conference on Harmonization (ICH) guidelines.
Organizational skills: Advanced clinical study coordinators are responsible for coordinating multiple aspects of clinical studies, including scheduling study visits, tracking participant data, and ensuring that all study activities are conducted according to protocol. Strong organizational skills and attention to detail are critical for success in this role.
Communication skills: Advanced clinical study coordinators must be able to communicate effectively with a wide range of stakeholders, including study participants, principal investigators, study sponsors, and regulatory agencies. This requires strong written and verbal communication skills.
Critical thinking and problem-solving: Advanced clinical study coordinators must be able to think critically and troubleshoot issues that arise during the course of a clinical study. They must be able to identify problems and implement solutions to keep the study on track and ensure participant safety.

Overall, a combination of education, experience, and specialized skills is required to become an advanced clinical study coordinator. However, there are many different pathways to this career, and some employers may have specific requirements or preferences depending on the type of studies they are conducting.

If you are not sure if this is the right training for you, we are happy to help you make the right decision. Email us at academy@viares.com and we will contact you.

clinical research online course - clinical study coordinator

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Clinical Study Coordinator II – Enterprise

€ 239,90

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€ 239,90

Clinical Study Coordinator II – Enterprise

COURSE Content

VIARES CERTIFICATE

Hear from our graduates

Magda

Nadia

WHY BECOME an advanced clinical study coordinator?

What are typical responsibilities of an advanced clinical study coordinator?

IS THIS THE BEST OPTION FOR ME?

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