Clinical Research Coordinator II at Care Access

Poland (Remote)Full-timeRemotePhysician & Site Alliance-OUSPosted 30 days 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><h3>How This Role Makes a Difference</h3> <div> The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.  </div> <h3>How You'll Make An Impact</h3> <ul> <li>Coordination and Conduct of Clinical Trials <ul> <li> Study Planning and Scheduling: <ul> <li>Prioritizing tasks according to study protocol timelines.</li> <li>Managing scheduling conflicts between visits and procedures through close collaboration with Investigators, nurses, and the PSC.</li> </ul> </li> <li> Regulatory Compliance: <ul> <li>Adhering to FDA and ICH GCP guidelines in clinical trial conduct.</li> <li>Ensuring all study procedures are performed in accordance with Good Clinical Practice (GCP) standards.</li> <li>Maintaining knowledge of and compliance with internal Care Access SOPs in daily activities.</li> </ul> </li> <li> Collaboration with the Study Team and Participants: <ul> <li>Professional communication with the Principal Investigator (PI), study staff, and Sponsor/CRO representatives.</li> <li>Close cooperation with investigators and the study team, supporting investigators and nurses during patient visits, and ensuring patient documentation is prepared prior to visits.</li> <li>Maintaining participant relationships in alignment with protocol and ethical requirements.</li> <li>Training participants on study materials (e.g., paper or electronic diaries), supporting device usage, verifying entries, issuing and collecting diaries, etc.</li> </ul> </li> <li> Monitoring Quality and Safety: <ul> <li>Tracking quality metrics and visit outcomes.</li> <li>Supporting investigators in identifying and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) in line with protocol and procedures.</li> <li>Preventing protocol deviations and promptly resolving issues in documentation and study processes.</li> <li>Participating in selection, initiation, monitoring, and close-out visits; collaborating with monitors, analyzing findings from post-visit letters, implementing corrective actions, and confirming completion of all prior visit issues.</li> <li>Preparing the site for audits and inspections and participating in these activities.</li> <li>Controlling versions of key study documents (Investigator’s Brochure, protocol, manuals).</li> <li>Verifying investigators’ review and documentation of safety reports (SUSARs).</li> <li>Ensuring correct execution of informed consent forms (ICF) and proper documentation of the consent process.</li> </ul> </li> </ul> </li> </ul> <ul> <li>Clinical Trial Documentation <ul> <li>Data Registration and Verification: <ul> <li>Accurate and timely verification of data in both paper and electronic documentation (e-source, if applicable) and entering data into study systems (eCRF, IVRS, etc.).</li> <li>Ensuring completeness of data and adherence to protocol requirements.</li> <li>Managing the Investigator Site File (ISF), ensuring completeness, and obtaining necessary documents from team members.</li> <li>Preparing documentation for participant requests and, if electronic, delivering the package via PSC.</li> </ul> </li> <li> IMP Control and Compliance Monitoring: <ul> <li>Monitoring participant compliance, tracking returned medications, and notifying investigators of discrepancies.</li> <li>Responding to alerts from study systems (lab, IVRS, e-diaries) and confirming investigator acknowledgment.</li> <li>Supporting nursing staff in reporting issues to the CRO and responding to queries.</li> </ul> </li> <li> Query Resolution and Regulatory Support: <ul> <li>Resolving data queries within the designated timeframe.</li> <li>Collaborating with the regulatory team to prepare and archive study documents.</li> <li>Assisting with source documentation and CRF review, including transmitting requests for source creation, providing study documents, implementing and verifying corrections, and consolidating team feedback.</li> <li>Updating key study documents on the site OneDrive (protocol, ICF, CVs, GCP certificates).</li> </ul> </li> </ul> </li> </ul> <ul> <li>Study Start-Up Support <ul> <li>Submission Documentation Preparation: <ul> <li>Compiling and preparing all documents required by Sponsor/CRO. </li> <li>Ensuring all documents are correctly completed and compliant with guidelines. </li> <li>Verifying signatures and dates before submission. </li> </ul> </li> <li> Staff Documentation and CV Management: <ul> <li>Preparing investigator and study staff CVs using Sponsor/CRO templates (if applicable). </li> <li>Updating and verifying personal data and qualifications of the study team. </li> </ul> </li> <li> Coordination with Study Team and Sponsor/CRO: <ul> <li>Providing complete, accurate, and signed documentation to Sponsor/CRO. </li> <li>Collaborating with PI, study staff, and regulatory teams to ensure documentation compliance. </li> <li>Supporting preparation of all materials required for study start-up approval. </li> </ul> </li> <li> Document Quality Control: <ul> <li>Verifying completeness and compliance of documents with protocol and regulatory requirements. </li> <li>Ensuring documentation readiness for formal submission and archiving. </li> </ul> </li> </ul> </li> </ul> <ul> <li>Site Training and Preparation <ul> <li>Study-Specific Training: <ul> <li>Conducting timely trainings and clinical trial sessions, participating in Sponsor/CRO trainings and investigator meetings. </li> <li>Organizing and delivering training for study staff in accordance with protocol requirements. </li> <li>Ensuring all team members are trained, have system access, and possess current Sponsor/CRO-required certifications. </li> <li>Documenting staff training participation and archiving training materials. </li> <li>Mentoring of incoming CRCs (as needed) </li> <li>Training for new CRC</li> </ul> </li> <li>Site Preparation for SIV:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" 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">Verifying availability of all materials, equipment, and documents required for Site Initiation Visit (SIV).</li> <li data-leveltext="" data-font="Symbol" data-listid="11" 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">Coordinating SIV logistics with Sponsor/CRO and PI.</li> <li data-leveltext="" data-font="Symbol" data-listid="11" 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">Ensuring site readiness in accordance with protocol, regulatory requirements, and GCP standards before study initiation. </li> </ul> </li> <li>Protocol Review and Analysis:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" 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">Evaluating protocol feasibility, including amendments, with respect to logistics and ethical requirements.</li> </ul> </li> <li>Visit Reporting: <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Accurately reporting visits and procedures; ensuring proper entry of all participant visits and clinical procedures into the CCS system. </li> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Verifying data prior to financial reconciliation; ensuring additional procedures are documented correctly before submission for payment. </li> </ul> </li> <li>Study Logistics:  <ul> <li>Verifying availability of study materials and equipment: lab kits, IMP, specialized devices, system access (IVRS/EDC), passwords, and permissions, and providing technical support to investigators. </li> </ul> </li> <li>Site Operations Support: <ul> <li data-leveltext="" data-font="Symbol" data-listid="15" 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">Supporting site operations for non-study-specific activities (office work, equipment, resources) as agreed with the supervisor. </li> <li data-leveltext="" data-font="Symbol" data-listid="15" 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">Managing assigned equipment responsibly. </li> <li data-leveltext="" data-font="Symbol" data-listid="15" 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">Liaising with vendors during the study, coordinating participant visits scheduling, updating patient files with test results, and cooperation in resolving Sponsor queries. </li> <li data-leveltext="" data-font="Symbol" data-listid="15" 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">Providing backup support in the absence of the primary CRC. </li> <li data-leveltext="" data-font="Symbol" data-listid="15" 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">Creating study schematics in CCS</li> </ul> </li> <li>PSSV (Pre-Study Site Visit):  <ul> <li>Summarizing required documentation prior to PSV, participating in PSSV (on-site or remote) ; post-visit reporting and documentation preparation remain CRC responsibilities. </li> </ul> </li> </ul> </li> </ul> <ul> <li>Additional Technical Support: <ul> <li>Setting up email accounts and providing IT support for investigators; preparing initial CVs. </li> <li>Performing any other tasks as assigned by the supervisor. </li> <li>The above responsibilities are not exhaustive and may be expanded, reduced, or reassigned based on business needs and current circumstances </li> </ul> </li> </ul> <h3>How We Work Together</h3> <ul> <li>Location: Onsite within Poland</li> <li>Work Schedule for CRC:  <ul> <li>Mandatory 3–4 days on-site; remote work possible when no in-person activities are required (patient visits, monitoring, SIV, close-out, PSV, audit, work with medical documentation etc.). Workdays on-site and schedule changes will be agreed with Site Manager. </li> <li>Flexible on-site hours based on patient visit schedules; otherwise, fixed hours both on-site and remote.</li> </ul> </li> </ul> <h3>Benefits & Perks</h3> <ul> <li>Paid Time Off (PTO) and Company Paid Holidays</li> <li>Medical, dental, and vision insurance plan options</li> </ul><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:[email protected]">[email protected]</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>

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