Clinical Research Coordinator (CRC)

The Clinical Research Coordinator course is designed for those with basic to experienced researchers who are functioning as a study coordinator. It is also beneficial for those considering entry into this field or those who are relatively new to the conduct of clinical trials. This course is an extensive training program and provides many helpful tools and techniques that are directly applicable to their roles in clinical research. The curriculum is designed to provide a strong foundation in the role of CRC, Good Clinical Practices and medical ethics.

Independent clinical research companies arrived with the increased need for researchers to conduct clinical studies. Physicians most often serve as the Principal Investigators during the clinical phases of the trial and drug development. However, most committed physicians do not have the time to be fully involved in the clinical research process and therefore seek qualified staff to manage the research.

Clinical Research Study Coordinators (CRC), is the individual working for the Investigator or a University/academic institution who handles most of the patient follow up and administrative responsibilities of a clinical trial, is the liaison between the clinical trial investigative site and the sponsor of the clinical trial, and reviews all data and records before a Sponsor visit. The title of the CRC can be research nurse, trial coordinator, study coordinator, research coordinator, or clinical coordinator.

CRC’s are also responsible for the organization, coordination, and overall integrity of a research project. To ensure the safety of research participants and compliance with regulations, the Institutional Review Board (IRB) requires all interventional protocols to have a Study Coordinator. The duties of Study Coordinators are delegated by the Principal Investigator, such as, consenting of research subjects, ensuring accuracy of the data recorded, acting as liaison between the study sponsor and the Institution, acting as liaison between the Principal Investigator and the IRB and other Institutional officials and committees, and general oversight of conduct of protocols. CRC's receive direction from principal and co-investigators. Responsibilities may also include: protocol development, screening, recruiting and enrolling participants, consenting, collecting data, scheduling, dispensing study drugs and managing the use of devices, ensuring accuracy of documentation, and maintaining databases. The CRC’s are considered the ‘right-hand’ of the research physician.

There is a great need for certified and experienced professionals in the field of Clinical Research Study coordination. Agencies and Colleges offer these courses on a semester basis (3-4 months) with tremendous fees and cost to the applicants.

Clinical Research Study Coordinators have a very dynamic and challenging position that offers a host of opportunities for growth and career development. Salary ranges vary ($28,000 - $63,000) depending on education and years of experience.

Through extensive research and collaboration with Sponsors, Investigational Sites, and CROs, Academy of Clinical Research has created a unique training program to incorporate both industry specific knowledge and skills with practical clinical trial experience. This program is designed to provide training in International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) guidelines, investigative site coordination, knowledge and understanding of FDA regulations.

Academy of Clinical Research has designed the Essentials of Clinical Trial Management Certification course, to prepare the CRC in the following areas:

ESSENTIALS OF CLINICAL TRIAL MANAGEMENT

Introduction to Clinical Research
Phases of Clinical Trials
Good Science, Ethics, Research and the Law
Good Clinical Practice Guideline
Institutional Review Board and Subject Rights
Protocol Development
Basic Elements of the Protocol
Protocol Compliance
The Informed Consent Process
Elements of Informed Consent
Essential Documents
Source Documents
Electronic-Case Report Forms
Types of Visits
Adverse Events/Serious Adverse Events

Interactive Voice Control System
Subject Recruitment
Advertising
Academy Certification Exam

Our goal is to prepare students with the knowledge, understanding and skills to manage clinical trials INDEPENDENTLY.

Academy of Clinical Research is currently enrolling students for the Essentials of Clinical Trial Management course (Level I to Intermediate). This course is conducted by Research Scientists and Study Coordinators who have over 10 years of industry experience.

**Upon successful completion of the course, the student will receive two certificates. The certificates are for successfully completing the Academy of Clinical Research course in Clinical Research Coordinator training and a second certificate of completion in Good
Clinical Practice guidelines. **

Clinical Research Associate (CRA)

This course is designed to provide knowledge and training for Clinical Research Associate (CRA) to play a vital role in protecting the study participant and helping to reduce the time between drug development and marketing approval. CRAs have the responsibility to recruit investigators, initiate studies, monitor, close down clinical sites at the end of studies, monitoring that the physician adheres to Good Clinical Practices, and the study protocol.

Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial on behalf of a sponsor (pharmaceuticals, biologics, or biotech devices companies).

Pharmaceutical companies are presently seeking to reduce the development time necessary for their products to receive FDA approval for marketing. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. Inadequate monitoring can jeopardize the safety of the study participant and/or is a leading contributor to the delay in gaining drug approval. A well- trained and knowledgeable CRA plays a vital role in protecting the study participant and helping to reduce the time between drug development and marketing approval. The demand for knowledgeable and trained CRAs continues to grow, however the supply is limited.

A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.

CRAs have the responsibility for recruiting investigators, initiating studies, monitoring and closing down clinical sites at the end of studies. In addition, CRAs are expected to be able to write protocols, study design, design Clinical Report Forms and write Final Reports when studies are completed. Monitoring that the physician adheres to Good Clinical Practices and the study protocol; Performing study drug accountability; Verifying the documentation of the informed consent process for each study subject; Ensuring that non-serious and serious adverse experiences are properly documented and reported; Reviewing case report forms against the subject's medical record for completeness and accuracy; Ensuring the filing and maintenance of the required regulatory documents.

A CRA can work either in-house or in the field, requiring 50-70% travel with all expenses paid by the hiring company. A field monitor will visit multiple sites and interact with the study coordinator and the investigator conducting the trial.

Is there a large job market for Clinical Research Associates in the industry?

Yes, it is a continually expanding industry, especially due to a growing biotech industry. CRA's are on the forefront of this industry due to the serious impact they can have in the drug, device, and biologic approval process. Pharmaceutical companies, contract research organization, academic institution, or site management organization usually employs the CRA.

What is the starting salary for a CRA?

Salaries start at about $40,000 to $45,000. Some CRAs may receive a higher salary due to their background and education. After one year of experience the CRA will usually be able to transition into a position earning over $50,000. A CRA with 4 plus years experience can earn from $ 65,000 to over $100,000. Experienced CRAs have many flexible employment options (work from home, part-time, independent consultant, etc.)

Some of the subjects discussed during the training include but are not limited to the following:

Introduction to Clinical Trials
Trial Terminology
Foundation: Clinical Trails and different phases
What is a Protocol and Good Clinical Practice Guidelines
Investigational Product Development Process
Ethics (IRB), Research and the Law
The CRA
Data Management
Clinical Research Team Responsibilities
Clinical Trial Preparation-Essential Documents
Pre-Study Visits
Initiation Visits
Monitoring Visits
Closeout Visits
Adverse Event Analysis and Reporting
Serious Adverse Event Reporting
Academy Certification Exam

Academy of Clinical Research is currently enrolling students for the Essentials of Clinical Research Associate course (Level I to Intermediate). This course is conducted by Research Scientists and Study Coordinators who have over 10 years of industry experience.

**Upon successful completion of the course, the student will receive two certificates. The certificates are for successfully completing the Academy of Clinical Research course in Clinical Research Associate training and a second certificate of completion in Good Clinical Practice guidelines. **

Good Clinical Practice / International Conference on Harmonization

Our Physician-Principal Investigator education program is designed for practitioners who are transitioning into a research principal investigator and/or sub-investigator role within the clinical research industry. This program covers various topics critical to understanding the clinical research industry and the role of an investigator. The course covers the FDA regulations, Good Clinical Practice Guidelines, and other topics that are imperative to investigators such as; informed consent, investigator responsibilities, protocol compliance, adverse events/ serious adverse event documentation, protocol non-compliance, fraud and FDA inspections and audits

The standard to which clinical trials must conform is called Good Clinical Practice (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted.

Good Clinical Practice is a set of guidelines that must be followed when conducting clinical trials to ensure that the rights and well-being of the trial participants are protected and that the data generated in the trial is valid.

Good clinical guidelines have three properties.

First, they define practice questions and explicitly identify all their decision options and outcomes.
Second, they explicitly identify, appraise and summarize, in ways that are most relevant to decision-makers, the best evidence about prevention, diagnosis, prognosis, therapy, harm, and cost-effectiveness.
Third, they explicitly identify the decision points at which this valid evidence needs to be integrated with individual clinical experience in deciding on a course of action. Thus, the good ones don't tell you which decision to make, but identify the range of potential decisions and provide you with the evidence which, when added to your individual clinical judgment and your patient's values and expectations, will help you make your own decision in the best interest of your patient."
Description - This course is an extensive training program for clinical research coordinators and Investigators, and provides many helpful tools and techniques that are directly applicable to their roles in clinical research. The curriculum is designed to provide a strong foundation in Good Clinical Practices and medical ethics.

Site Staff and Hospital Training

Academy of Clinical Research realizes that your time is valuable. Therefore, our professionals are available to conduct the training of your staff, in compliance with FDA and GCP/ICH guidelines, at your location or at our headquarters, located in Irving, Texas. Our instructors will familiarize your staff in the proper conduct of clinical research studies/trials, compile documentation and test results necessary to adhere to Institutional Review Board and Good Clinical Practices procedures. We invite the opportunity to discuss various options available to facilitate the training of your staff.

This training course offers State of the Art knowledge and specific instructions on clinical site management. A successful completion will enable the students to qualify for certification as Clinical Research Coordinator (CRC).

Academy of Clinical Research instructors can come to your facility to conduct any of our clinical research training courses. In addition, the instructors can tailor our existing proprietary programs to better suit your needs and areas of focus within your organization.

Contract Review and Budget Negotiation

Physicians most often serve as Principal Investigators during clinical phases of the trial and drug development. However, most committed physicians do not have the staff or the time to become involved in the clinical research start up process. Even when they have the interest, these clinicians are faced with a complex process that includes: contacting the sponsor companies and finding studies relevant to their interest and expertise, accurate and timely completion of large amounts of paperwork, reviewing contracts and negotiating budgets and fees or training their staff to conduct the study which is an expensive and time consuming ordeal. Our highly skilled and knowledgeable staff is available to provide the clinical site with the consultation and expertise on proper trial management and submission of all trial related documents and clarification of issues and query management in a timely manner. Academy of Clinical Research staff can provide on site study coordinator training for your research management needs.

Audit Preparation

An audit is an integral part of this process and ensures the validity of research data from which conclusions are drawn. In order to maintain the integrity of the audit process, auditors are necessarily independent of the sites at which the data is generated. Thus, preparing for an audit, including the preparation of institutional records that verify reported data, is generally the responsibility of the institutional CRA. This preparation is crucial, since questions raised on audit often require a lengthy resolution process that can involve sanctions against the site. Academy of Clinical Research staff is available to prepare the clinical site for a successful audit.

Recruitment Assistance (CRC & CRA)

Academy of Clinical Research encourages Pharmaceutical Sponsors, Physicians, Clinical Research Organizations (CROs), Site Management Organizations (SMOs) and all other industry vendors/providers to hire our highly trained and motivated learners. The graduates are certified through the Academy of Clinical Research by displaying vast knowledge tested through extensive examination and by hands-on experience obtained at our associated clinical sites and hospitals. For a dedicated, skilled and qualified prospect, please contact us for more information.

Pre-Study Site Selection Visit

Based on Sponsor requirements and/or feasibility outcome, Academy of Clinical Research is staffed with highly qualified and experienced personnel to perform all pre-study visits. Our Project Managers and senior Clinical Research Associates will conduct the PSSV and discuss the possibility and suitability of all potential investigators and site staff. Academy of Clinical Research staff will recommend only the most suitable study sites to the Sponsors. This can drastically cut down on the cost and time for the sponsors.

SOPs and Regulatory Document Preparation

Trial specific regulatory/compliance and clinical advice and strategy at the early stages of product development can be critical to the ultimate approval of the product. Failure to address regulatory and compliance concerns early in the development program often results in delays in approval due to improperly designed studies, omitted studies, manufacturing oversights and other failures to meet key regulatory requirements. Timely submission of all trial related documents, including proper Standard Operating Procedures, could play a crucial part in the sponsors decision to accept the site for specific trials. Academy of Clinical Research professionals are highly versed in generating site specific SOPs, and proper completion and submission of all required regulatory file documents and logs.