Central Study Coordinator

Summary

Join Care Access as a Central Study Coordinator (CSC) and contribute to revolutionizing access to clinical trials. This remote role combines clinical research and project management, supporting one to four research sites concurrently. As a CSC, you will manage study work, build rapport with various stakeholders, and ensure high-quality participant experiences. Responsibilities include participant screening, consenting, visit facilitation, data management, and query resolution. The role requires strong clinical research experience, proficiency in various technologies, and excellent communication skills. Care Access offers competitive benefits, including paid time off, comprehensive health insurance, and a 401k retirement plan.

Requirements

• 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)
• At least 3 years of relevant clinical research experience
• Advanced communication skills both verbally and in writing
• Able to speak to all levels of an organization
• People mentoring abilities
• At least 4 years of relevant clinical research experience, and at least 1 year as a high performing CSC I

Responsibilities

• 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 Adverse Events and Serious Adverse Events (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
• 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

Preferred Qualifications

• CCRC preferred
• Fluency in Spanish is a bonus
• CCRC preferred
• Fluency in Spanish is a bonus

Benefits

• 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