CRC Training course:
the PI is responsible for the conduct of the trial, “it has been said that the
CRC is the heart and soul of the research study and that, ultimately, it is the
CRC who carries forward the research goals, thereby playing a significant role
in the success of the research study. Most importantly, CRCs are often involved
in essential duties that have been traditionally performed by the PI, such as
conducting the informed consent process and ensuring compliance with the
The CRC’s primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the CRC has many other responsibilities. Although not inclusive, some of the CRC's responsibilities include:
- Document adverse events;
- Prepare or review documents submitted to the institutional review board (IRB);
- Protocol review or study procedures planning;
- Participate in conducting subject visits;
- Maintain source documents;
- Prepare for and participate in study visits with monitor, sponsor, auditors, etc.;
- Participate in consent process;
- Writing the informed consent document;
- Developing a detailed cost analysis;
- Negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency);
- Subject recruitment;
- Patient care;
- Preparing the case report form (CRF);
- Submitting CRFs and other data to the Sponsor/CRA as necessary; and
- Study close-out.
Upon completion of the course, participants will be able to:-
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Code, evaluate, or interpret collected study data.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Record adverse event and side effect data and confer with investigators regarding the reporting of
- events to oversight agencies.
- Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Maintain contact with sponsors (CRAs) to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
With the knowledge and job skills gained as a result of your study, you can help to meet the ever-growing demand for trained CRCs to develop exciting new therapeutics for the 21st century in the biotechnology, pharmaceutical and medical device industries.
The CRC certificate is recognized internationally in all the countries that are signatories to the ICH-GCP guidelines for clinical trials. This includes USA, Canada, Israel, Germany, Switzerland, Italy, UK, France, EU countries, Russia, Ukraine, Czech Republic, China, Spain, India, Japan, Hong Kong, Australia, New Zealand, Singapore, South Africa and many others.
Job Placement Assistance:
- As a graduate you will receive assistance to update your resume to include your new qualifications.
- Your resume will have industry-specific terminologies that will guarantee that you get interviews.
- Graduates are routinely referred to employers who contact us regularly when looking to hire CRCs.
- Our graduates are given lifetime access to our exclusive Clinical Research jobs database.
- Recruiters and Employers post their entry-level and other CRC jobs to our exclusive jobs database.
• 100% Online, Self-Paced Training, Start Anytime from Anywhere.
• Average completion time - 2 to 4 Weeks.
• Actual completion time varies depending on your pace of study.