• Study/Patient Coordination
  • 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.
  • Pre-screen and educate potential study participants on the study.
  • Analyze, understand, and be knowledgeable of the study protocol and the associated disease(s) in combination to be able to educate patients and their families on what participating in the study means for the patient
  • Interpret patient reported medical history and medication use to determine pre-screening qualification for a study
  • Manage participant referral portals and study specific applications in real time in accordance with GCP.
  • 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.
  • Perform protocol mandated visit activities while maintaining GCP compliance
• Documentation Management
  • Maintain all study documentation in accordance with ALCOA-C and across multiple study portals.
  • Collect sensitive data that is used to determine overall study effectiveness
  • Create and manage sensitive source documentation for multiple studies including maintaining document security, quality assurance, and secure transmission to clients in a remote environment
  • Enter data and resolve queries in EDC and other portals within appropriate time window defined by the study
  • Correctly identify, document, and report Adverse Events and Serious Adverse Events (AEs and SAEs)
  • Ensure all study trackers and systems are up to date daily
  • Support site compliance with subject safety reporting
• Study Project Management
  • 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.
  • Requires juggling multiple unique protocols of varying complexity
  • Host regular calls, acting as the subject matter expert and representative of Care Access, 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.
  • Facilitate communication between study site, CRA, and sponsor.
• Other Responsibilities
  • Build strong rapport with sites, participants, CRAs, and sponsor contacts.
  • Make decisions that optimize the experience within the study for the participant, PI, and other site staff.
  • Perform quality checks for self and others to ensure overall data integrity.
  • Complete ongoing trainings and adhere to system access guidelines.
  • Analyze and understand study protocols.

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)

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • Bachelor's Degree preferred, or equivalent combination of education, training and experience
• Minimum Experience:
  • At least 3 years of relevant clinical research experience
• Fluency in Spanish is a bonus
• CCRC preferred