That's why there's such a high demand for clinical research coordinators CRCs to run the clinical trials that test new drugs, treatments and medical devices. If you're interested in becoming a research coordinator, there are plenty of jobs out there for you. You can work with innovative technology and use the job as a stepping stone to even bigger career opportunities. That's because of the opportunities that are out there right now - not to mention the cool technology and the cures that they're coming up with," said Michael Mazza , a divisional practice lead based in the Philadelphia area.
We asked Mazza and Lacy Preddie , an account recruiting manager, more questions about this hot career path. CRCs recruit patients and conduct the day-to-day operations for clinical trials. Most coordinators work in research hospitals. Although it varies by employer, applicants are typically required to have a bachelor's degree in clinical research management, medical technology, public health or nursing.
Or maybe I was reviewing patient records to locate potential candidates, updating study logs, or ordering supplies. Regardless of the specific duties I was performing each day, my hours were long and my days were hectic. According to the NIH , the number of registered clinical research studies has increased by nearly 40 percent since Source: ClinicalTrials. So this represents a major disparity between the number of trials CRCs report that they can safely and effectively manage and the number of trials they are actually assigned.
Almost one-quarter revealed that they were dissatisfied with their jobs, and many more reported only moderate job satisfaction.
Not surprisingly, turnover rates among CRCs are high, with more than half leaving their positions within three years and citing heavy workload burnout as the primary reason.
Why are protracted hours and chaotic schedules so common among CRCs? Willingness to be challenged Seeks ways to overcome obstacles Exceeds minimal expectations. Over the lifetime of a clinical trial, an experienced CRC is responsible for coordinating and implementing many study-related activities. A key attribute of a successful study is the organizational capabilities of its CRC. Serious complications can result when records e. These complications can result in institutional review board IRB sanctions, funding withdrawal, probation, administrative suspension or termination, and unusable data.
Anticipating problems can help prevent potential punitive actions. Study Start-Up: There are a variety reasons why a study may fail to launch in a timely manner.
The CRC is typically responsible for facilitating study start-up activities to ensure that a study begins within the projected timeframe. A great CRC will develop and implement organizational techniques, such as a checklist to prioritize and complete tasks. These tasks include engaging stakeholders, creating budget projections, identifying study staff, determining space needs, and ensuring timely submission of documents.
Appropriate time management during start-up activities can decrease delays in recruitment, help the site meet its study goals, and increase overall study efficiency.
Timely start-up also avoids fiscal pitfalls that may have a negative impact on sponsors. The stricter the eligibility of a research study, the more difficult it can be to find appropriate participants.
A great CRC will be well organized and will establish a quick mental checklist using a methodical approach. To enhance navigating eligibility, a great CRC might create a laminated quick-reference pocket guide for easy elimination of ineligible participants during the screening process.
If a prospective participant is more than 40 years old, then the CRC can quickly move to the next potential participant to screen. Minimize Participation Burden: Historically, participant travel, financial hardships, and other logistical concerns have been barriers to recruitment into clinical trials. A well-versed CRC understands the importance for participants to be adherent to their study appointments.
A great CRC will seek alternative means of transportation, visit locations, and investigate reimbursement options for the participants to help offset potential travel and financial burden and to better facilitate logistical issues that might otherwise disrupt study participation. Ensure Data Monitoring Accuracy: The CRC collects and inputs data from many sources; therefore, data must be accurate, reliable, and verifiable. One of the crucial data points of a clinical trial is reporting adverse events AEs , serious adverse events SAEs , and safety issues in a timely manner.
A well-organized CRC may create electronic medical record alerts e. Clinical Trials Awareness: Having a clear understanding of other competitive trials allows the CRC to better navigate or facilitate recruitment strategies. A great CRC will be aware of competing clinical trials within the same geographical and therapeutic areas involving the same target population.
In addition to being knowledgeable of other projects current or upcoming , a great CRC should be a resource for individuals interested in opportunities for participating in clinical trials. Former research participants often inquire about other projects for which they may qualify—especially studies that fall within a health condition of interest.
First impressions matter, and can develop into relationships lasting the duration of each trial; this fact alone can increase patient retention rates. In addition to recruiting subjects, one of the primary responsibilities of a CRC is to help them navigate the various research entities involved in studies e.
Therefore, the CRC must create a relationship of trust and dependability as a research case manager for the participant. R apport: It is advantageous for CRCs to build rapport with potential participants who express interest in studies. Addressing participant questions, translating study jargon, and achieving a mutual understanding about the purpose of the study before proceeding with the informed consent can establish a solid relationship foundation.
This safe zone creates an atmosphere in which participants can share their personal or health information relative to studies, communicate concerns about being research subjects, and discuss any other barriers that may prohibit their participation. By establishing a strong rapport with participants, CRCs become a trusted point-of-contact for studies. A ccountability: The PI is ultimately accountable for the overall conduct of a study, while the CRC is generally responsible for day-to-day operations.
A good CRC supports the PI in ensuring the safety and well-being of the study participant, and is often the link among the PI, study participants, other study team members e. The CRC customarily oversees the proper execution of, and adherence to, an approved protocol by ensuring accurate and timely study data collection, and by maintaining the highest standards of regulatory compliance.
Coordinators are responsible for ensuring the trial meets all regulations including those regarding safety, government rules and regulations, and company or hospital ethics. The patients are kept track of by the coordinator in terms of health and progress, and the results are reported to the company. Coordinators may need to find funding for their research, whether through private funds or grants.
Clinical research coordinators have to not only apply for and attain the grants and funding for the research, they must also figure out an amount for the funding they require. Cost analysis is a large part of this job, as the coordinator must put together a budget that includes how much the research will cost, as well as payroll, travel for both professionals and subjects , supplies, technology including internet, fax, and telephone costs , pharmacy costs, and other costs that will affect the budget of the trial.
In order to find subjects for the trials, clinical research coordinators must decide if there are enough willing participants that fit the description of patients necessary for the trials.
Once this has been determined, the coordinators agree to take on the project and hire their research team.
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