This role requires an active RN license. 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:
Licensed RN in the state of Pennsylvania
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:
Able to navigate and troubleshoot a wide variety of technologies used for clinical research including recruitment platforms, IWRS, EDC, and other clinical trial software, and able to work across multiple platforms at the same time
Proficient with Microsoft Office applications (Word, Outlook, Teams, and Excel)
Demonstrate professionalism in all situations and work effectively with a diverse group of individuals
Understand when issues require escalation
Strong communication customer service abilities
Proficient in research terminology and basic medical terminology
Understand the overall clinical development paradigm and excellent working knowledge of government regulations, GCP, and ALCOA-C
Strong organization and time management skills
High attention to detail
Ability to work in a fast-paced environment
Critical thinker and problem solver
Ability to work effectively in a remote environment
Proper home office set-up including a private space for participant communication and high-speed internet (at minimum: 100MB up and 15 MB down, 5 GHz router)
CSC II includes all the above plus the following:
Advanced communication skills both verbally and in writing
Able to speak to all levels of an organization
People mentoring abilities
Certifications/Licenses, Education, and Experience:
At least 3 years of relevant clinical research experience
CCRC preferred
Fluency in Spanish is a bonus
Active Pennsylvania RN licensure
At least 4 years of relevant clinical research experience, and at least 1 year as a high performing CSC I
CCRC preferred
Fluency in Spanish is a bonus
Active Pennsylvania RN licensure
Benefits (US Full-Time Employees Only)
PTO/vacation days, sick days, holidays.
100% paid medical, dental, and vision Insurance. 75% for dependents
HSA plan
Short-term disability, long-term disability, and life Insurance
Culture of growth and equality
401k retirement plan
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