Monitoring clinical trials at a high level requires a unique set of traits, skills, and abilities. While monitors often have diverse backgrounds and experiences, there are specific attributes that characterize great monitors and separate them from the rest of the pack. The following list identifies those attributes and explains why each is instrumental to clinical monitoring. This list is not ranked in any particular order and is not meant to be all inclusive; please share your thoughts!
- Flexibility: This is critical in order to adapt to constantly changing travel arrangements, shifts in job priorities and/or responsibilities (often based on sponsor or site needs), and the ability to work effectively with new personnel both at the site and sponsor. In addition, great monitors possess the adaptability to work successfully both individually and within a team as well as remotely and on-site. Flexibility is also required when working with multiple sponsor and sets of SOPs.
- Dynamic Working Style: Closely related to flexibility, great monitors are as dynamic as the clinical trials that they monitor. Each day brings new priorities, opportunities, and challenges in protecting data integrity and patient safety. The monitor must thrive in this type of work environment and be comfortable with a routine that often changes on a daily basis.
- Effectively Balancing Multiple Priorities: Highly skilled monitors know how to effectively manage time in order to attend to the most pressing needs without drowning in those that can wait until a later time. This can be difficult when working with multiple projects, sponsors, and deadlines, but developing this skill is essential to optimal job performance.
- Attention to Detail: Being detail-oriented would seem fairly obvious, but the importance of this can’t be understated. This skill is not only required for comprehending data, medical records, study protocols, regulatory documents, and conducting product accountability, but also in communication with study teams, physicians, and even in coordinating travel arrangements.
- Top Notch Preparation: Monitors must always be adequately prepared and well-organized for any site visit, training session, study meeting, or other type of interaction with colleagues, sites or sponsor representatives. In addition, while on site, preparation must be made to ensure maximum efficiency of the visit and use of investigator/study team time.
- Excellent Communication Skills: Outstanding verbal and written communication skills are necessary to effectively interact with colleagues both within and outside of your company. This is also important when writing reports, conducting training sessions, or delivering presentations at study meetings or outside events. In addition, the monitor must be comfortable corresponding with study support teams. These teams include supervisors, project specialists, project managers, clinical specialists, medical monitors, physicians, and many others. The monitor isn’t necessarily expected to have the answer to every question, but should know the appropriate person to contact in any situation.
- Familiarity with Applicable Regulations: Great monitors have an excellent working knowledge of CFR, ICH, GCP, and other applicable regulations. In addition, these monitors base their guidance and instructions provided to site personnel on these regulations. Additionally, a skilled monitor will have a thorough understanding of any additional rules and regulations that are unique to the site and/or IRB.
- Ability to Consume Information Efficiently: This is a skill that often increases with job experience and is undoubtedly a characteristic of a top-level monitor. During a site visit, it is not uncommon to be required to review hundreds of pages of medical records in order to verify trial data. The monitor may also be required to process large numbers of emails, site action items, or study documents. It is important to be able to quickly and effectively focus on the important information without completing losing sight of peripheral matters.
- Skilled in Training: This is often overlooked but is a critical characteristic of a great monitor. This is necessary for training physicians, study coordinators, and junior monitors. In addition, during site visits, the monitor must be skilled in training or re-training site personnel to avoid duplication of noted problems and increase future compliance.
- Highly Developed Interpersonal Skills: This ability has a profound effect on the link between sponsors, investigators, and patient safety. A great monitor will have the ability to effectively work with all personality types and will be able to navigate such relationships in a manner that produces results and desired outcomes. It is also important for the monitor to have a clear understanding of the dynamics of a monitor-coordinator relationship. The monitor must work collaboratively and respectfully with the research coordinator in order to achieve mutual goals and build rapport.
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