Central Study Coordinator I

United StatesRemote1d ago

About the role

<div class="content-intro">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 <a href="http://www.careaccess.com/">www.CareAccess.com</a>.</div><div> <h3>How This Role Makes a Difference</h3> <div> 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.    </div> <div> <h3>How You'll Make An Impact</h3> <div> Study/Patient Coordination  <ul> <li>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.  </li> <li>Pre-screen and educate potential study participants on the study.  </li> <li>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 </li> <li>Interpret patient reported medical history and medication use to determine pre-screening qualification for a study </li> <li>Manage participant referral portals and study specific applications in real time in accordance with GCP. </li> <li>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.  </li> <li>Perform protocol mandated visit activities while maintaining GCP compliance </li> </ul> Documentation Management  <ul> <li>Maintain all study documentation in accordance with ALCOA-C and across multiple study portals.  </li> <li>Collect sensitive data that is used to determine overall study effectiveness </li> <li>Create and manage sensitive source documentation for multiple studies including maintaining document security, quality assurance, and secure transmission to clients in a remote environment </li> <li>Enter data and resolve queries in EDC and other portals within appropriate time window defined by the study </li> <li>Correctly identify, document, and report Adverse Events and Serious Adverse Events (AEs and SAEs)   </li> <li>Ensure all study trackers and systems are up to date daily </li> <li>Support site compliance with subject safety reporting </li> </ul> Study Project Management  <ul> <li>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. </li> <li>Requires juggling multiple unique protocols of varying complexity </li> <li>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. </li> <li>Prepare meeting agendas and circulate meeting minutes, follow-up on action items for self and teammates. </li> <li>Facilitate communication between study site, CRA, and sponsor.  </li> </ul> Other Responsibilities <ul> <li>Build strong rapport with sites, participants, CRAs, and sponsor contacts.  </li> <li>Make decisions that optimize the experience within the study for the participant, PI, and other site staff.  </li> <li>Perform quality checks for self and others to ensure overall data integrity.  </li> <li>Complete ongoing trainings and adhere to system access guidelines. </li> <li>Analyze and understand study protocols.   </li> </ul> </div> <h3>The Expertise Required</h3> <div> Knowledge, Skills, and Abilities:  <ul> <li>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.  </li> <li>Proficient with Microsoft Office applications (Word, Outlook, Teams, and Excel).  </li> <li>Demonstrate professionalism in all situations and work effectively with a diverse group of individuals.  </li> <li>Understand when issues require escalation.  </li> <li>Strong communication customer service abilities   </li> <li>Proficient in research terminology and basic medical terminology   </li> <li>Understand the overall clinical development paradigm and excellent working knowledge of government regulations, GCP, and ALCOA-C   </li> <li>Strong organization and time management skills   </li> <li>High attention to detail   </li> <li>Ability to work in a fast-paced environment.  </li> <li>Critical thinker and problem solver.  </li> <li>Ability to work effectively in a remote environment.  </li> <li>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) </li> </ul> </div> <div> <h3 class="text-body text-muted">Certifications/Licenses, Education, and Experience</h3> </div> <div> <ul> <li>Minimum Education: <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Bachelor’s Degree preferred, or equivalent combination of education, training and experience.  </li> </ul> </li> <li>Minimum Experience: <ul> <li>At least 3 years of relevant clinical research experience    </li> </ul> </li> <li>Fluency in Spanish is a bonus.  </li> <li>CCRC preferred. </li> </ul> </div> <h3>How We Work Together</h3> </div> </div> <div> <ul> <li>Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.</li> <li>Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.</li> <li>Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.</li> </ul> The expected pay range for this role is $75,000 - $95,000 USD per year for full time team members. <h3>Benefits & Perks (US Full Time Employees)</h3> <ul> <li>Paid Time Off (PTO) and Company Paid Holidays</li> <li>100% Employer paid medical, dental, and vision insurance plan options</li> <li>Health Savings Account and Flexible Spending Accounts</li> <li>Bi-weekly HSA employer contribution</li> <li>Company paid Short-Term Disability and Long-Term Disability</li> <li>401(k) Retirement Plan, with Company Match </li> </ul> </div><div class="content-conclusion">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: <a href="mailto:TalentAcquisition@careaccess.com">TalentAcquisition@careaccess.com</a> 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: 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. </div>

Perks & benefits

401k
Vision Insurance
Paid Time Off
Pension Matching

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