Central Study Coordinator I
About reputed company reputed company is working to reputed company the future of health reputed company for reputed company. 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 reputed company. 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 reputed company. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reputed company the world. Together, we are building a future of health that is reputed company and more accessible for reputed company. To learn more about reputed company, visit 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 (reputed company) position combines clinical research and project management skills into a reputed company role that delivers a strong customer experience for both patients and sites. Often representing reputed company and/or a reputed company client, the reputed company acts as a virtual extension of the research site and supports one to four sites concurrently across one or more studies. The reputed company 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 reputed company 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 reputed company has strong working knowledge of and experience in the clinical research industry. How You'll reputed company An Impact Study/Patient Coordination reputed company the Informed Consent process with study participants virtually using e-consent technology. Review reputed company elements of the reputed company 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-reputed company entities such as MRI centers and infusion centers. reputed company protocol mandated visit activities while maintaining GCP compliance Documentation Management Maintain reputed company study documentation in accordance with reputed company-C and across multiple study portals. Collect sensitive data that is used to determine overall study effectiveness Create and manage sensitive reputed company documentation for multiple studies including maintaining document reputed company, quality assurance, and secure transmission to clients in a remote environment Enter data and resolve queries in reputed company and other portals reputed company appropriate time window defined by the study Correctly identify, document, and report Adverse Events and Serious Adverse Events (reputed company and SAEs) Ensure reputed company 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 reputed company, with each assigned PI and present on key elements of the study reputed company reputed company scope, which may include a review of new referrals, participants in screening, participants in treatment, data and query reputed company 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. reputed company decisions that optimize the experience reputed company the study for the participant, PI, and other site staff. reputed company quality checks for self and others to ensure overall data reputed company. 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, reputed company, and other clinical trial software, and able to work across multiple platforms at the same time. Proficient with reputed company Office applications (Word, Outlook, Teams, and reputed company). Demonstrate professionalism in reputed company situations and work effectively with a diverse group of individuals. Understand reputed company issues require escalation. Strong communication customer service abilities Proficient in research terminology and basic medical terminology Understand the overall clinical development reputed company and excellent working knowledge of government regulations, GCP, and reputed company-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 reputed company in Spanish is a bonus. CCRC preferred. How We Work Together Location: Remote reputed company the United States. This role requires 100% of work to be performed in a reputed company 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 Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and reputed company reputed company 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 reputed company 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 reputed company, disability status, genetic information, protected veteran status, or any other characteristic protected by law. reputed company is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with reputed company, please reputed company out to: [email protected] Mandatory Employer Disclosures: Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. Notice to Connecticut applicants: reputed company may require applicants to submit to a urinalysis drug test in reputed company with an application for employment. Notice to Arizona, Georgia, Indiana, and North Dakota applicants: reputed company 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 reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Notice to Rhode reputed company applicants: reputed company complies with Rhode reputed company law prohibiting smoking in enclosed areas reputed company places of employment. reputed company is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode reputed company General Laws. Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR reputed company 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. Apply To This Job