How This Role Makes a Difference

How You'll Make An Impact

• Coordination and Conduct of Clinical Trials
  
  • Study Planning and Scheduling:
    • Prioritizing tasks according to study protocol timelines.
    • Managing scheduling conflicts between visits and procedures through close collaboration with Investigators, nurses, and the PSC.
  • Regulatory Compliance:
    • Adhering to FDA and ICH GCP guidelines in clinical trial conduct.
    • Ensuring all study procedures are performed in accordance with Good Clinical Practice (GCP) standards.
    • Maintaining knowledge of and compliance with internal Care Access SOPs in daily activities.
  • Collaboration with the Study Team and Participants:
    • Professional communication with the Principal Investigator (PI), study staff, and Sponsor/CRO representatives.
    • Close cooperation with investigators and the study team, supporting investigators and nurses during patient visits, and ensuring patient documentation is prepared prior to visits.
    • Maintaining participant relationships in alignment with protocol and ethical requirements.
    • Training participants on study materials (e.g., paper or electronic diaries), supporting device usage, verifying entries, issuing and collecting diaries, etc.
  • Monitoring Quality and Safety:
    • Tracking quality metrics and visit outcomes.
    • Supporting investigators in identifying and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) in line with protocol and procedures.
    • Preventing protocol deviations and promptly resolving issues in documentation and study processes.
    • 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.
    • Preparing the site for audits and inspections and participating in these activities.
    • Controlling versions of key study documents (Investigator’s Brochure, protocol, manuals).
    • Verifying investigators’ review and documentation of safety reports (SUSARs).
    • Ensuring correct execution of informed consent forms (ICF) and proper documentation of the consent process.

• Clinical Trial Documentation
  • Data Registration and Verification:
    • 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.).
    • Ensuring completeness of data and adherence to protocol requirements.
    • Managing the Investigator Site File (ISF), ensuring completeness, and obtaining necessary documents from team members.
    • Preparing documentation for participant requests and, if electronic, delivering the package via PSC.
  • IMP Control and Compliance Monitoring:
    • Monitoring participant compliance, tracking returned medications, and notifying investigators of discrepancies.
    • Responding to alerts from study systems (lab, IVRS, e-diaries) and confirming investigator acknowledgment.
    • Supporting nursing staff in reporting issues to the CRO and responding to queries.
  • Query Resolution and Regulatory Support:
    • Resolving data queries within the designated timeframe.
    • Collaborating with the regulatory team to prepare and archive study documents.
    • Assisting with source documentation and CRF review, including transmitting requests for source creation, providing study documents, implementing and verifying corrections, and consolidating team feedback.
    • Updating key study documents on the site OneDrive (protocol, ICF, CVs, GCP certificates).

• Study Start-Up Support
  • Submission Documentation Preparation:
    • Compiling and preparing all documents required by Sponsor/CRO.
    • Ensuring all documents are correctly completed and compliant with guidelines.
    • Verifying signatures and dates before submission.
  • Staff Documentation and CV Management:
    • Preparing investigator and study staff CVs using Sponsor/CRO templates (if applicable).
    • Updating and verifying personal data and qualifications of the study team.
  • Coordination with Study Team and Sponsor/CRO:
    • Providing complete, accurate, and signed documentation to Sponsor/CRO.
    • Collaborating with PI, study staff, and regulatory teams to ensure documentation compliance.
    • Supporting preparation of all materials required for study start-up approval.
  • Document Quality Control:
    • Verifying completeness and compliance of documents with protocol and regulatory requirements.
    • Ensuring documentation readiness for formal submission and archiving.

• Site Training and Preparation
  • Study-Specific Training:
    • Conducting timely trainings and clinical trial sessions, participating in Sponsor/CRO trainings and investigator meetings.
    • Organizing and delivering training for study staff in accordance with protocol requirements.
    • Ensuring all team members are trained, have system access, and possess current Sponsor/CRO-required certifications.
    • Documenting staff training participation and archiving training materials.
    • Mentoring of incoming CRCs (as needed)
    • Training for new CRC
  • Site Preparation for SIV:
    • Verifying availability of all materials, equipment, and documents required for Site Initiation Visit (SIV).
    • Coordinating SIV logistics with Sponsor/CRO and PI.
    • Ensuring site readiness in accordance with protocol, regulatory requirements, and GCP standards before study initiation.
  • Protocol Review and Analysis:
    • Evaluating protocol feasibility, including amendments, with respect to logistics and ethical requirements.
  • Visit Reporting:
    • Accurately reporting visits and procedures; ensuring proper entry of all participant visits and clinical procedures into the CCS system.
    • Verifying data prior to financial reconciliation; ensuring additional procedures are documented correctly before submission for payment.
  • Study Logistics:
    • 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.
  • Site Operations Support:
    • Supporting site operations for non-study-specific activities (office work, equipment, resources) as agreed with the supervisor.
    • Managing assigned equipment responsibly.
    • Liaising with vendors during the study, coordinating participant visits scheduling, updating patient files with test results, and cooperation in resolving Sponsor queries.
    • Providing backup support in the absence of the primary CRC.
    • Creating study schematics in CCS
  • PSSV (Pre-Study Site Visit):
    • Summarizing required documentation prior to PSV, participating in PSSV (on-site or remote) ; post-visit reporting and documentation preparation remain CRC responsibilities.

• Additional Technical Support:
  • Setting up email accounts and providing IT support for investigators; preparing initial CVs.
  • Performing any other tasks as assigned by the supervisor.
  • The above responsibilities are not exhaustive and may be expanded, reduced, or reassigned based on business needs and current circumstances

How We Work Together

• Location: Onsite within Poland
• Work Schedule for CRC:
  • 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.
  • Flexible on-site hours based on patient visit schedules; otherwise, fixed hours both on-site and remote.

Benefits & Perks

• Paid Time Off (PTO) and Company Paid Holidays
• Medical, dental, and vision insurance plan options