Just as our leading researchers and physicians must innovate to deliver cutting edge therapeutic interventions, we must also innovate when it comes to study conduct. Dedicated Clinical Research Coordinators deliver solutions to challenges at site and work collaboratively with the team to achieve timely completion of the trial.
What makes a Dedicated Clinical Research Coordinator the ideal solution for sites seeking to conduct clinical trials?
Recognises the many competing challenges for the site staff and seeks to integrate the study requirements seamlessly within the wider clinical setting.
Collaborates with other departments as necessary eg. Pathology, Imaging
Liaises with other key stakeholders (Sponsor, Clinical Research Organisation and Human Research Ethics committee, site, and patients).
Evaluates new protocols, achieves site selection, completes required documents including feasibility, study budget and contracts.
Coordinates administrative and clinical aspects of a clinical trial under the supervision of, and as delegated by the Principal Investigator.
Attends investigator meeting, sponsor initiation and ongoing monitoring visits.
Undertakes training as necessary and ensures a backup coordinator is equally trained.
Conducts patient visits according to protocol.
Ensures the collection and entry of quality data and resolves queries.
Prioritises patient recruitment and retention
Works flexibly attending site only as needed and working remotely otherwise, keeping costs as low as practicable. (May be included in budget from Sponsor)
Acquires equipment and maintains required documentation such as Temperature logs.
Completes closeout and archive at study end.
“I have worked with Louretta on and off over the past 12 years – Louretta was and still is the study coordinator on many of the clinical trials that I have monitored in my capacity as a CRA.
Louretta is always very responsive to emails and last-minute requests, has an excellent eye for detail and is well liked by all the study participants – I have never heard of a complaint against her work or her care of study participants – she works well with Investigators, Sponsors and other study coordinators and is always prepared to go that one step further that is so critical in the clinical trial setting.The role of a study coordinator is not often a 9 to 5 job so having a coordinator like Louretta involved makes it so much easier – often these patients require additional time and support, and many will want additional reassurance which Louretta willingly provides.Many of the clinical trials that she has worked on have had trouble recruiting but Louretta seems to have a knack for enrolling study participants at an excellent rate and especially in first in human studies which typically are not easy to recruit for – I wish her the best of luck and am grateful of the opportunity of working with her! ”