The Clinical Trials Guru is releasing a new book for people who are new to clinical research. New site owners may benefit from from this book, as it explains what sponsors look for in sites. A major quality being patient enrollment which will go a long way in maintaining a healthy relationship between sites and sponsors.
Clinical research has come a long way from the days were patients were enrolled in studies either without consent or complete disclosures. Three major events which helped change the way research is conducted are the Nuremberg Code, Declaration of Helsinki, and The Belmont Report . These major events should not be forgotten as they are integral components for protecting patient rights.
Successful businesses must be able to guarantee that there is a minimal viable product that is available for customers. In research, the minimum viable product is simply a study and a physician. Of course, that is only a minimum requirement and a site should be able to go above and beyond a sponsor’s expectations.
Being an employee doesn’t mean that you will be restricted to a stagnant position. It is therefore advised to treat whatever position you find yourself in as a business. Coordinators for example, can easily find networking opportunities that can lead to self employment through CRA positions, consulting, or quality assurance.
Well seasoned site owners now that it isn’t wise to rely on a single PI. Using sites such as LinkedIn can serve as an excellent resource for recruiting new physicians who can serve as PI or Sub-I’s. LinkedIn can help narrow the search for potential physicians to those in the nearby area.
This video delivers a true life example of a person that started with no research experience but is currently a clinical research coordinator. During his first attempts to enter the research field, he was told he couldn’t be a CRC because he didn’t have enough experience. After being an intern at a local research site, this CRC has quickly accumulated a wealth of research related knowledge and he is ready to take his first steps as a monitor.
The Clinical Trials Guru answers questions during this video and is accompanied by a knowledgeable research coordinator. During the conversation topics such as monitors look for in order to complete a successful SIV are discussed. This conversation takes into consideration both a monitor and a research coordinator’s point of view.
This video serves as a personal note about what it be like to have a fresh new start in the research industry. One of the fist things to do is to focus on networking with sponsors and other research professionals. One way to find key sponsor and CRO personel through https://clinicaltrials.gov/.
Most private sponsored research uses Central IRB’s to approve documents relating to advertisements, protocol approvals, and ICF’s. Having a central IRB is preferred because it allows the sponsors to distribute approved documents more efficiently. Central IRB’s also streamline the study startup phase for each site which in turn allows sites to recruit quicker.
Taking your first steps into the clinical research industry is not as difficult as it might seem at first. This video demonstrates that it is indeed possible to start a career in clinical research by offering a site assistance with recruitment. In this case, the lack of experience in clinical research was leveraged as a way to relate to patients who are not typically familiar with clinical research.
Site management requires a high level of organization in order to ensure that the site can be profitable. Keeping track of study leads, current studies, PI’s, Sub-I’s, and patients are major pieces of information site directors need to address. Tools such as hubspot and excel can be used in unicence to better suit a site’s needs.
Research sites can offer a large amount of experience which can be accessed by interning at sites. In this video, a Clinical Trials Assistant wants to be a CRA but lacks site closure experience. One option that this Clinical Trials Assistant has is to leverage their experience opening sites by offering help to sites in exchange for experience watching a site closure.
Every site that has gone through a sponsor audits can testify that these audits are very stressful. The best thing to do is to prepare ahead of time by having your QA personnel review the sponsor’s charts and paying attention to important documents such as the ICF. Be aware that even though your site is the one being audited, asking your CRA for assistance is greatly encouraged as their work will also be reviewed.
This video provides helpful tips for different members of the research community. Those who are working to get past their entry level position are advised to expand their skill set by offering assistance with tasks that are beyond their comfort zones in order to provide value to their company. Site owners on the other hand are advised to monitor their business closely and provide assistance to any struggling site as needed.
Universities are starting to develop programs for students interested in a degree in clinical research. Universities are in a unique position in which they can attract a large population of students and prepare them for a career in public or private research. Although there are only a few universities considering such programs, their potential to impact the research industry is guaranteed.
Failure to screen an adequate amount of patients within a specified time frame may prompt a sponsor to close a site. Sponsors may warn sites to at the very least pre-screen patients. Other requests that sponsors will make include asking a site to develop a new recruitment plan, meet with recruitment staff, or request that the site updates the sponsor on their weekly recruitment efforts.
A CRA must constantly watch pay extra attention to details. As this video explains, data reconciliation is a major part of a CRA's duties. Focusing on data reconciliation can uncover deviations and queries that the site must address immediately.
All sites whether they are new or old should always know where their next studies will come from. Sites should take advantage of the study surplus this year which is promising to be a year with many study opportunities. Recruiters are a smart investment for sites who don’t have a large patient database but want to be ready for their next studies.
Running a successful research site doesn’t happen overnight. In fact most new sites can go months without seeing income from any studies even after their first site initiation visit. Once a site is finally able to manage several studies, the site can be more selective when choosing which studies to accept.
This video offers an insightful conversation from a new study coordinator’s perspective on different monitoring styles. Monitors who practice a hands off monitoring style can be easier to work with but can actually set your site up for danger in the event of an FDA audit. Because of this, it is important to ask questions from your monitor and review your charts regularly.