
Care Access · USA Remote
About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians acros...
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and
clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to
care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they
need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities
worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put
people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical
research and health services reach the world. Together, we are building a future of health that is better and more accessible for
all.
To learn more about Care Access, visit www.CareAccess.com [http://www.careaccess.com/].
Reporting to the Sr. Director of Study Feasibility & Clinical Partnerships, the Associate Director and Director of Study
Feasibility & Clinical Partnerships provides strategic leadership for protocol and site feasibility across the Care Access Site
Network and oversees the end-to-end lifecycle of clinical vendor partnerships that support Care Access objectives. This role is
responsible for shaping and advancing feasibility strategy, ensuring robust site evaluation, and driving the identification,
sourcing, qualification, onboarding, negotiation, and performance management of key vendors.
In close partnership with cross-functional teams, including Business Development, SSU, Finance, and Site Operation, this position
guides data-driven feasibility assessments across the site network, leads cost-effective procurement strategies, strengthens
contractual and operational frameworks, ensures regulatory and organizational compliance, and cultivates high-impact,
high-performing vendor partnerships that enable successful study execution and organizational growth.
Strategic Team Supervision and Development
collaborative, high-performing team environment.
alignment, high performance, and seamless study execution.
processes, and best-practice SOPs to enhance operational efficiency and effectiveness
Clinical Trial Feasibility and Vendor Acquisition and Management Strategy
objectives, protocol requirements, and operational needs.
assess feasibility across the Care Access Site Network, identify appropriate vendor scope, and ensure alignment of feasibility
and vendor capabilities with study needs for optimal execution.
allocation to support efficient and effective study execution.
across development operations.
management practices, escalation pathways, and performance improvement approaches.
support governance discussions and continuous improvement activities.
performance data, issue trends, and operational inputs
timelines, or study deliverables.
Cross-Functional Collaboration and Strategic Input
operational strategies with broader organizational objectives.
strategic decision-making.
Other Responsibilities
Practice.
stakeholders.
CROs.
requirements, staff needs, and company initiatives. During onboarding and training, additional travel may be required.
The expected pay range for this role is $120,000 - $160,000 USD per year for full time team members.
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or
conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an
application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in
and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of
employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places
of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT,
PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER
WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
#LI-Remote
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a
team representing the communities we 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 are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to,
and will not be discriminated against on the basis of, 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.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
[TalentAcquisition@careaccess.com]
About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit www.CareAccess.com [http://www.careaccess.com/]. HOW THIS ROLE MAKES A DIFFERENCE 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. Often representing Care Access and/or a Care Access client, 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. HOW YOU'LL MAKE AN IMPACT * 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. THE EXPERTISE REQUIRED 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 HOW WE WORK TOGETHER * Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment. * Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected pay range for this role is $75,000 - $95,000 USD per year for full time team members. BENEFITS & PERKS (US FULL TIME EMPLOYEES) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match #LI-Remote Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we 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 are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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. If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com [TalentAcquisition@careaccess.com]
Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. Who we are looking for: Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune programs. The ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The successful candidate will report to the Vice President, Clinical Operations. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects. Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry, and an understanding of clinical drug development and clinical trials operations are essential. Key areas of responsibilities: * Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives * Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs * Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan * Support the selection, oversight, and management of CROs and other vendors * Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team * Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate * Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations * Assist in forecasting clinical trial material and ancillary supplies * Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures * Ensure timely review of protocol deviations and assess the impact on study data * Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders * Perform and document study level Sponsor Oversight of outsourced clinical activities * Communicate study status, cost, and issues to ensure timely decision-making by senior management * Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct * Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma * Support program level deliverables/activities at the discretion of the Head of Clinical Operations * Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise * Oversee or conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs and ensure all appropriate documents are filed * Participate and respond to Quality Assurance and/or regulatory authority inspection audits * Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in conjunction with CRO and appropriate internal stakeholders * Manage the clinical trial budget and provide financial reporting and projections to Finance * Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and Outsourcing as necessary Qualifications: * BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred * Minimum of 8 years of experience in clinical research with at least 5 years of managing trials in the biotech/pharma industry and/or prior CRO experience * Experience in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's and/or Myasthenia Gravis experience preferred * Experience working on late-stage studies (Phase II, III) * Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail * Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, and proven effectiveness in a fast-moving and growing biotech environment * Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials * Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required * Ability/willingness to travel as required * Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry The salary range for this position is expected to be between $195,000 and $220,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.
About Inizio Ignite: Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Company Descriptor Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward. About the team: We have recently established a new Scripting Team in India, based in Gurgaon. This hub is part of the global Operations team and sits within the Data Management & Dashboard Delivery (DMD) capability. The team supports ad hoc, tracking and syndicated quantitative studies as the business transitions from an outsourced vendor model to a stronger blended / in-house delivery model. The team scripts and maintains online questionnaires for healthcare professionals, patients and other key stakeholders. By integrating complex logic, customized routing, validation checks and robust testing, the team ensures high-quality data capture and supports downstream data processing, analytics, dashboarding, reporting and insight generation. As the team scales, the priority is to strengthen scripting quality, technical governance, capability-building and readiness for more complex programming requirements. Your primary role: The Scripting Senior Manager - SME is a senior Subject Matter Expert role within the Scripting department, reporting to the Associate Director, Data Management & Dashboard Delivery (DMD). The role provides the highest level of in-house scripting expertise for India DMD and acts as the technical authority, escalation point and quality owner for complex survey programming. This role is critical to scaling the scripting function and de-risking the transition from outsourced delivery to a blended / in-house model. It combines hands-on complex scripting with technical governance, quality ownership, team coaching, process development, capability-building and stakeholder advisory. The successful candidate will help build confidence that the India team can deliver increasingly complex scripting requirements to the required quality standard while reducing dependency on external vendors. This will include: * Acting as the senior technical SME for the Scripting department, providing expert oversight across complex online survey programming, advanced logic, routing, validation, quotas and respondent experience. * Providing hands-on scripting and programming of high-complexity online surveys using the Confirmit platform, including custom logic, advanced routing, validations, quality controls and troubleshooting. * Exploring emerging survey technology, AI-enabled research tools and automation opportunities, with the ability to assess which solutions can practically improve scripting quality, speed and scalability. * Acting as the escalation point for complex scripting issues, technical risks and quality concerns across ad hoc, tracking, Pathfinder, Ignite, syndicated and other quantitative study types. * Providing upfront technical review of complex questionnaires to identify scripting risks, confirm feasibility and recommend efficient survey design solutions * Supporting the transition from an outsourced model to a blended / in-house model by assessing scripting complexity, identifying readiness gaps, highlighting capability or resourcing risks and capturing lessons learned as work moves in-house. * Building and delivering an upskilling plan for the scripting team, with particular focus on complex programming requirements such as conjoint exercises, segmentations, advanced routing, trackers and syndicated study complexity. * Providing technical guidance, mentoring and quality feedback to Scripting Senior Managers, Managers and Executives; line management may be included where required as the team scales. * Partnering closely with Research, Project Management, Data Processing, Dashboarding and Analytics teams to ensure scripting design supports accurate downstream data flow, tabulation, dashboarding and reporting. * Advising internal stakeholders on scripting best practice, feasibility, risks, options and solutions, translating technical considerations clearly for non-technical audiences. Your skills and experience: * More than 11 years of experience in a senior scripting role within a market research agency, with evidence of operating at SME / technical lead level; healthcare / life sciences market research experience is strongly preferred. * Deep proficiency in Confirmit's scripting platform, including authoring, complex logic implementation, deployment, testing, troubleshooting and quality control. * Strong practical knowledge of JavaScript, HTML and CSS for customizing survey functionality, layout and respondent experience. * Experience using AI or automation tools to improve survey scripting, QC, documentation, code review or workflow efficiency. * Proven experience scripting complex quantitative research studies, ideally including trackers, syndicated studies, conjoint exercises, segmentations, complex routing, quotas and validation requirements. * Strong understanding of quantitative research methodologies, questionnaire structures, healthcare market research standards and the downstream implications of scripting decisions for data processing, analytics, dashboarding and reporting. * Experience establishing, maturing or improving an in-house scripting function, ideally including process design, quality frameworks, documentation, training plans and transition from outsourced delivery. * Demonstrable experience mentoring, coaching and developing scripting team members, including quality feedback, capability-building and support for complex technical problem solving. * Strong analytical judgement, problem-solving ability and the confidence to identify, escalate and resolve quality, feasibility or delivery risks. * Excellent communication skills, with the ability to explain technical issues, options and implications to non-technical stakeholders in an international environment. Ideal profile: * You are a hands-on technical expert who can operate as the senior SME, quality owner, escalation point, coach and trusted advisor to senior stakeholders. * You are comfortable sitting above the standard Senior Manager role, providing expert challenge, guidance and technical assurance without losing the ability to get hands-on when needed. * You are proactive, dedicated and enthusiastic, with a can-do attitude and a strong ownership mindset. * You demonstrate a high level of accuracy and attention to detail, as well as strong organisation and prioritization skills. * You are comfortable working in a scaling team where processes are still being built and where ambiguity needs to be turned into clear ways of working. * You are collaborative and able to build effective relationships across Research, Project Management, DMD, Data Processing, Dashboarding, Analytics and UK stakeholder groups. * You communicate ideas, risks and issues in a clear, practical and solution-focused way. * You are motivated by the opportunity to build a new scripting capability, strengthen in-house delivery and develop others. * Experience developing reusable scripting templates, code libraries, macros, checklists, QC frameworks or automation tools that reduce manual effort and improve the TAT Life at Research Partnership: We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide: - A comprehensive training and development programme for all staff, from entry level apprentice to senior management. - Opportunities for international travel and collaboration. - A relaxed and friendly working environment. Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.