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.
The best entry level positions for research naive people who are trying to enter the research industry are at the site level. It doesn’t matter if the position is interning for free, entering data, or helping the site with recruitment. Each site has different needs and may be able to offer some type of experience which can then be added to your CV.
More people are becoming aware of the benefits of being a CRA. However, few people consider other job opportunities in clinical research that can better suit their personal strengths. Jobs such as Project Manager allow people to work on a study while exercising a high level of organization and logistic expertise.
This video includes a live instruction from The CRA Academy. During this lesson topics such as Corrective Action Preventive Action plans are discussed. The purpose of this lesson is to prepare CRA students for what to expect during situations where CAPA plans or site trainings are required.
Having experience in the research industry can be the most important resource for those of you who want to open your own site. For most, the best way to get experience will be to take an entry level position at a research site. As always, the positions that will help get you the experience you need are clinical research coordinator, research assistant or at least recruitment.
Sponsors typically have access to a wide array of vendors that can provide various research related services. Some of the vendors are able to help sponsors keep track of analytics such as query resolution rates for sites. Site owners should be aware of this information and expect it to affect whether or not a site is selected for any given study.
Job a applicants should be prepared to demonstrate an understanding of research related concepts during interviews. This is because many employers may ask questions relating to IRB's or CFR's and expect competent answers. Simply having a degree will not guarantee a job when the applicant lacks an understanding in research.
Switching PI in the middle of a studies can be dangerous and may cost you a study. One way to prevent this from getting out of hand is to have a Sub-I that can take over studies if needed. SItes that don’t have access to physicians should regularly seek local physicians that might be interested in clinical research.
No one in the industry will tell you what you need to do in order to improve your site. Because of this, site owners who are looking for ways to make their sites more profitable should take more active roles in their sites. Site owners should also encourage their staff to go above and beyond what is expected, as doing so can benefit the site.
2019 is a good year to set resolutions but it is also a good year to expand your talents. For sites this means adding new nurses or Sub-I’s that can help enter new indications and reach a wider study supply. For coordinators this means obtaining QA experience and adding it your CV in order to become a better CRA candidate.
Landing your first CRA job will take a lot of dedication. You must first submit as many applications as possible. Even after you land your first job, you might still need need additional support from sources such as the CRA Academy.
Whether you are a site owner, a coordinator, or a CRA, planning out your goals for the year is an important step towards progressing. This webinar focuses on several goals such as obtaining a Sub-I or acquiring studies which all site owners need to address. The focus for this webinar is on strengthening a research site but some of the ideas presented may be significant to employees and other research professionals.
The CRA Academy can provide students with unexpected experiences which can be added to the student’s CV. Such experiences can give students the exposure they need to land a desirable position. With enough experience CRA students can easily branch out into other research related positions that are related to clinical research.