New sites will often struggle to hire the right coordinator for their site. On the one hand they may be tempted to hire experienced coordinators who require greater payment, but on the other hand they may find it easier to hire an inexperienced coordinator and provide training. Alternatively, new sites can go through programs such as the CRA Academy which teach the basics of research and can prepare anyone to coordinate studies.
Sponsors should have possession of all regulatory documents before a study can begin. For this reason, sites seeking to start as soon as possible are advised to prioritize their submissions. Site owners should be especially concerned with completing and submitting these documents because any delays can mean a loss of revenue.
Investigator meetings serve as an opportunity to learn about the protocol and meet sponsor representatives. Anyone attending these meetings can also network vendors, site owners, PI's and other research professionals. One of the biggest goals for IM's is for the sponsor to provide training to research sites and answer any questions about the protocol.
Developing a protocol and finding suitable sites to conduct study related procedures is only the first step to getting a new medication out in the market. After a selection, an initiation visit must occur in order to prepare sites to screen their first patients. After each site reaches a screening or randomization milestone, sites must be monitored in order to prevent deviations, and identify any problems that sites may have encountered during patient visits.
Developing and executing a protocol is a long process that can take several years to complete. One of the first steps that sponsors must make involves meeting with the FDA in order to identify any major concerns that the study design must address. After finally getting approved by the FDA sponsors must get IRB approval and find sites that can provide clean data for analysis.
All sites, especially new ones will often struggle to find competent coordinators. Good talent is so hard to find that teaching employees to coordinate studies can be the best way to aquire good coordinators. Staff members who are successful coordinators are often highly adaptable and have the potential to become skilled CRA's.
It takes a great amount of skill to thoroughly review regulatory binders, which are loaded with essential documents. One of the many documents in the regulatory binder is the FDA form 1572 in which the PI informs the FDA that only qualified staff will be involved in the study. The regulatory binder also holds various logs, including the deviation, IP, training, and monitoring visit logs.
When it comes to research, nothing is more important than patient safety. An emphasis on patient safety should be central to any question about PI oversight, interview questions, SDV, etc. Even those who are new to research should be aware of the importance of putting the patient first.
Monitoring a clinical research site is requires a detailed understanding of the various essential documents that must be present in every investigator file. For this reason, highly trained CRA's can have a large earning potential. People interested in pursuing a CRA position can easily join the CRA Academy and learn about the various subjects discussed in this video which include remote monitoring, reporting an SAE and identifying problem sites.
In this video a future CRA shares her experiences in the CRA Academy. Because she was able to go to California to complete her internship hours, she was able to meet a CRA with 20 years of experience. After meeting the CRA, it has become evident that many successful CRA's have been coordinators prior to obtaining their position.
You can't become a good CRA overnight. Depending on your ability to learn new information and organize your workload properly, it may take almost a year to become a good CRA. Of course there are some who can quickly become great while others never do.
Monica, a clinical research coordinator, decided to participate in a clinical trial but was met with an underwhelming patient experience. After her negative experience she can safely assume that poor communication with patients can have a great impact on a site's enrollment goals. A possible explanation for these types of miscommunications may be that recruiters are not fully trained on all study requirements.
Very few people are prepared to open their own site. Those who manage to open one will find that they can substantially increase their income. Those who struggle to open a site may not be prepared to wait several months for a new study or wait almost a year before payment.
The responsibilities of a CRA extend beyond simply reviewing charts at various sites. A CRA must also verify a large amount of data in order to ensure the accuracy of the TMF. A consequence of verifying large amounts of patient data is that CRA's are required to write reports which document their findings and list pending action items.
As many people are aware, CRA positions pay very well but demand a lot. There are actually a few considerations to take into account before becoming a CRA including travel time, turnover, and workload. It is not uncommon for individuals who were initially looking for a CRA position to pursue a different position instead.
Site Selection Visits are designed match sponsors with sites that will carry out a trial with the least amount of difficulties and while enrolling the appropriate amount of patients. For sites who are in the middle of an SSV, it is important to be consistent with feasibility questionnaires when answering questions. The importance of enrollment cannot be understated so sites should be consistent and realistic, but should also be willing to set enrollment goals high.
Many people are interested in the CRA position because of the high pay rates and exposure to clinical research. However, CRA's must be able to manage a large number of emails and information from sponsors. The best CRA's must be highly organized and efficient in order to manage several sites at the same time.
Cancer is one of the most researched indications. Unfortunately, patients who are actively searching for potentially beneficial clinical trials are often unable to find such trials. Another obstacle that clinical trials face is that many patients are not confident in the quality of the trials.
Blockchain is an emerging technology that has the potential to disrupt many industries including clinical research. Systems like these can create a platform in which patients can easily be reached and pre-qualified, but issues about consent and being able to opt out of the system are must be addressed. Nevertheless, block chain technology be able to lower health costs and provide a way to monetize healthy behaviors.
Most pharmaceutical and CRO companies require CRA's to have at least 2 years of experience. While people who are interested in becoming a CRA might not like that fact, most CRA employers will appreciate the value of an experienced CRA. The savings from using an experienced CRA will then reduce some of the costs of running a clinical trial.