The recent draft guidance on Risk Based Monitoring (RBM) suggests that sponsors consider this when determining the timing, types, frequency and extent of monitoring activities.

‘The research coordinator serves an important role in ensuring the quality of the investigation at the investigative site…. the research coordinator often recruits subjects, collects and evaluates study data, and maintains study records.’ No kidding!

The experience and qualifications of the research coordinator should be evaluated when selecting the site for study participation. How long have they been in their current role? What about the length of time in their prior roles? Generally, people stay in jobs longer if they have good relationships with their peers. Does their CV have typos and grammatical errors? This might suggest a lack of attention to detail.

Are they a member of the Association of Clinical Research Professionals (ACRP)?

Are they a certified clinical research coordinator (CCRC)?

Membership of a professional association and being certified demonstrates to me that this person is committed to their profession and that they have a willingness to learn and grow. They are the types of coordinators you want working on your study. Their contribution is what makes a site successful.

They schedule time with their Principal Investigator (PI) on a regular basis to discuss enrolment, review labs and evaluate Adverse Events. Documenting that they met, and action items taken, demonstrates PI oversight, something inspectors look for.

If, for some reason, between site selection and study start, a new coordinator has taken over the study and review of his/her CV suggests that they are inexperienced and not a certified research coordinator (CCRC), then an on-site visit should be planned sooner rather than later.

You need assurance that they have been trained on the protocol, that no tasks have been delegated inappropriately, that they are aware of reporting and data entry requirements.

Make sure your Monitoring Plan has a pool of visits to accommodate this type of scenario.

Empower CRAs to use their critical thinking skills when it comes to risk. That needs to be their mindset.