Central Clinical Services enables decentralized and hybrid clinical trials by providing staff who virtually support patients and sites. The Central Study Coordinator (CSC) position combines clinical research and project management skills into a singular role that delivers a strong customer experience for both patients and sites. The CSC acts as a virtual extension of the research site and supports one to four sites concurrently across one or more studies. The CSC is accountable for study delivery at the patient level, including screening, consenting, and conducting protocol mandated study visits, and is expected to coordinate daily work using patient centric practices and a quality-first approach. The CSC also serves as a project manager for their assigned studies with their assigned PIs, helping their sites to stay on top of study deliverables in line with sponsor and CRO expectations. As such, this role will also manage monitoring visits, data management, and query resolution for their assigned sites, and ensure ongoing inspection readiness. This is a mid-to-senior level individual contributor role with the expectation that the CSC has strong working knowledge of and experience in the clinical research industry.
What You’ll Be Working On
Duties include but are not limited to:
Manage study work for each assigned site as delegated by the PI, collaborating with multiple sites and site teams concurrently to deliver the highest quality work with each participant for each site.
Build strong rapport with sites, participants, CRAs, and sponsor contacts.
Host regular calls with each assigned PI and present on key elements of the study within CSC scope, which may include a review of new referrals, participants in screening, participants in treatment, data and query progress and issues, upcoming monitoring visits, etc.
Prepare meeting agendas and circulate meeting minutes, follow-up on action items for self and teammates.
Make decisions that optimize the experience within the study for the participant, PI, and other site staff.
Facilitate communication between study site, CRA, and sponsor.
Pre-screen and educate potential study participants on the study. Manage participant referral portals and study specific applications in real time in accordance with GCP.
Perform the Informed Consent process with study participants virtually using e-consent technology. Review all elements of the ICF with the participant and assess their understanding to ensure the protection of human participants in clinical research. Complete signatures using the e-consent platform and register participants in IWRS.
Schedule, prepare for, and facilitate participant visits in accordance with the study protocol. This may include overseeing the required scheduling, logistics, technology requirements, and communication applications for participants, central raters, investigators, and other study-related entities such as MRI centers and infusion centers.
Maintain all study documentation in accordance with ALCOA-C.
Enter data and resolve queries in EDC and other portals within appropriate time window defined by the study.
Perform quality checks for self and others to ensure overall data integrity.
Complete ongoing trainings and adhere to system access guidelines.
Correctly identify, document, and report AEs and SAEs
Analyze and understand study protocols.
Support site compliance with subject safety reporting.
Ensure all study trackers and systems are up to date daily.
Additional duties and responsibilities may be assigned as needed.
CSC II includes all the above plus the following:
Manage and deliver special projects for the team.
Support and guide others on understanding of the protocol and GCP.
Train, mentor, and coach other CSCs on study conduct and CSC processes.
Identify solutions to issues with study processes, proactively identify and implement process improvements.
Autonomously evaluate competing activities and decide on priorities based on guidance provided by manager and study team.
Physical and Travel Requirements
This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
What You Bring
Knowledge, Skills, and Abilities: