THE NEXT STEP IN YOUR CLINICAL RESEARCH CAREER
If you have passion for the clinical operations aspects of a study, the RLCRA role is perfect for you. It’s a more specialised role, managing local and regional clinical teams to adhere to study timelines and a primary support for Project Managers. Regional Lead CRAs at Novotech are leaders in the CRA team and are the regional, country, and site specific experts.
As a key support for PMs, RLCRA’s cover the clinical scope of the study. They are responsible for adhering to project timelines and milestones, providing information at the global level for the Sponsor and helping to bring the CRA and PM team closer together.
For example, the RLCRA will identify regional, country, and site-specific guidelines to help provide instruction to the study team of what is required. This also allows for the Sponsor to be informed correctly about what is expected at each site, and how this affects the overall timeline of the study at each site. As a result, the RLCRA is the go-to person for all regional, country, and local requirement expertise.
Novotech supports all our employees by providing job specific training with the Learning and Development Department. For RLCRAs, Novotech provides the training and guidance needed for completing role specific activities and support for career development planning. We take pride in cultivating an environment that welcomes career development and progression through ongoing learning and a supportive team. All RLCRA’s are not only supported by their PM’s, but by their study teams, to help them succeed in their roles.
WHY IS THE RLCRA IMPORTANT TO STUDY SUCCESS?
One of the biggest challenges in clinical trials are project timelines. One of the reasons Novotech can successfully adhere to project timelines is because of our RLCRAs.
RLCRA’s are responsible for managing milestones updates or any other update at the global level of the study. They do this by managing the Novotech local team to meet or reflect the milestones or updates at both the country and site level. How does this happen in reality?
- If an IRB submission planned target date is fixed at the study level, the RLCRA is responsible for managing the Novotech regional team to ensure that the task is completed by the target date.
- If there is a protocol or informed consent form amendment, the RLCRA would manage the Novotech regional team to update the country and site ICF’s accordingly and submit the updated documents to the appropriate Health Authority and Ethics committee within the timeline.
RLCRA’s are also responsible for providing the right information at the country and site level so that the information can be delivered and reflected in the global documents and instructions. For example, RLCRA’s develop study plans and collect the respective information of each region and reflect that information in each plan.
WHY IS RLCRA A VALUABLE STEP IN YOUR CLINICAL RESEARCH CAREER?
There are quite a few differences between a Senior CRA and a Regional Lead CRA, including with whom the Team member is communicating with, who performs site visits, and what the role is in the overall study.
For example, a SCRA is a country specific role and therefore the main point of contact for the site. The SCRA performs onsite visits, where the RLCRA does not.
A RLCRA is a regional role and does not communicate with the site directly but works closely with the PM as the main point of contact for the CRA team. This allows the RLCRA to help manage the CRA team and resolve site issues that do not need to be escalated to the PM. This not only helps you learn how to manage groups of people, but also problem solve at the project and site level. These are integral skills in project management and line management.
The required skills for the RLCRA role include a higher level of experience and greater skillset than a SCRA. This is because the RCRLA focuses on regional projects and are more involved in the clinical operations of the project by working closely with the CRA team.
As a RLCRA, you will learn the nitty gritty of project management in clinical operations and site management, while also understanding regional and country specific requirements, including the timelines associated with various regions. The gap in skills, knowledgebase, and experience between a SCRA and PM role is large, and the RLCRA role is a great bridge of that gap.
In fact, many RLCRA’s move onto a PM role or Clinical Operations Management. The RLCRA role helps bridge the gap on knowledge and expertise from a local level to a regional and global level.
Hyunjung
Regional Lead Clinical Research Associate (RLCRA), Korea
HyunJung recently joined Novotech as an RLCRA. She has 12 years of experience in clinical trials, making her a great fit for the role. HyungJung enjoys the new role because she is the PM's chief assistant and helping support studies in ensuring the study timelines are being met. She loves managing the sites and CRA team through internal follow up and facilitating cooperation with everyone on the project. HyunJung's favorite aspects of the role include the support of learning and development while on the job and through the learning and development department. "I really enjoy managing and being responsible for the site management of the study." HyunJung hopes to progress into a PM role in order to be a line manager. Through her experience as an RLCRA, she will gain team leadership management, that will aid her in supporting her team and give her the required skills for project management by bridging the gap between SCRA and PM roles.
Evon
Regional Lead Clinical Research Associate (RLCRA), Malaysia
Evon recently joined Novotech as an RLCRA. Evon has a background in Medical Bioscience and has more than 10 years of experience in clinical research. She is experienced in a range of therapeutics areas including oncology, hematology, cardiology, endocrinology, rheumatology, hepatology, respiratory, psychiatry and vaccines. As a Regional Lead Clinical Research Associate, Evon enjoys working with the team members from various countries because of the close communication and discussions, she has with the teams as part of her role duties. Another aspect she enjoys about the role is solving different issues and complexities that arise in studies across different countries. Her experience working with cross-functional teams enables her to focus on collaborative success. She strongly believes that we need to help and encourage one another along the way, taking advantage of a group collective energy to accomplish more in less time.