Central Study Coordinator

What We Do 

Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. 

Who We Are 

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.  

Position Overview 

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.   

• CSC I: 
• 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.

• 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.

• This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. 

• CSC I: 
• 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.

• CSC I: 
• At least 3 years of relevant clinical research experience 
• CCRC preferred.
• Fluency in Spanish is a bonus.

• CSC II: 
• 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.

• 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

Diversity & Inclusion 

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.  

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the 

physicians and caring for patients. 

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. 

Care Access is unable to sponsor work visas at this time. 

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.