Yearly Archives: 2024

The more things change, the more they stay the same, especially when it comes to the clinical trial site selection process. Despite all the technological advances since the dawn of industry-sponsored research, sponsors are still facing many of the same challenges when trying to predict which sites will perform the best on their study.

It’s difficult enough sometimes to find qualified and motivated candidates for clinical research job openings who are following all the rules. So, when competition gets so cutthroat that an entire shadow network of fake references springs up to help foist illegitimate new hires on short-staffed or over-eager employers via skullduggery, caution should be the hiring manager’s byword. 

Like a first date for those seeking significant others in the realm of clinical research, the site qualification visit (SQV) by a monitor representing a potential study sponsor or contract research organization can make or break a relationship, says Lisa Ince, CCRC, CCRA, FACRP, a Project Manager I in oncology trials with the Clinical Solutions division of Syneos Health. 

The ability to move from intentions to actions in support of diversity, equity, and inclusion in clinical research is vital to opening more trials to underrepresented populations, and formulating a diversity action plan according to regulatory guidance is key to the process.

In a forthcoming peer-reviewed article for ACRP’s Clinical Researcher journal, Anthony Chew, a clinical trial operations professional and recent graduate of the MS program in Medical Product Development Management at San Jose State University, describes CRAs as serving as “the primary liaison between the sponsor and the site by monitoring and verifying data to ensure accuracy and adherence to protocols. They collaborate with investigators, conduct site visits [including for site feasibility/selection and validation/qualification purposes followed by study initiation and ongoing monitoring], and maintain strict documentation to guarantee the integrity of a trial.”