The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, Clinical Trial Coordinators, Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor.
Work with sites to adapt, drive and track subject recruitment in line with project needs and expectations.
Provide protocol and study related training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol.
Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.
Ensures that the informed consent process is properly conducted and documented for every participant, in line with applicable requirement and standards.
Exhibits meticulous care in upholding the privacy of all subjects/participants.
Escalates quality issues appropriately per the escalation pathway.
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols. Confirms IP has been dispensed an administered to participants in compliance with the study protocol. Leverages expertise in GCP, local regulations and Alira Health procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed.
Routinely reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness.
Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations.
Performs quality checks on regulatory documents per ALCOA+ principles, collecting copies for TMF filing. Supports audit readiness by submitting documents to the TMF, utilizing the filing index and medidata as necessary.
Supports research sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirms approvals.
Develops an in-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.
Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations.
Assists in set up/collection of site-specific ethics documents and site contract negotiation.
Provides monthly billing information to finance team, as required
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor
Consistently prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines. Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment progress and safety events collected. Â
Ensures integrity of source records and case report forms through review and verification for accuracy and completeness.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Completes consistent review of CRF queries, working closely with site staff and data management to resolve CRF queries on discrepant data.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Collaborates with study team members for project execution and performs additional duties and tasks as assigned.
Dedicated and results oriented with a bachelor’s degree in a relevant field (sciences, nursing, medical preferred).
Experience in the pharmaceutical, health care, biotech, medtech or CRO industries.
Experience in computer software and the ability to adapt to technology.
Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity.
Excels in organizational and time management skills, enabling effective multitasking in fast-paced environments while managing priorities, organizing time efficiently, and solving complex problems.
Team-oriented and flexible, able to prioritize shifting demands and opportunities.
Possess strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes.
Willing and able to travel up to 85% to support site visits and project needs, approximately 5-12 days of monitoring per month as appropriate for region of assignment.
Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.
Skilled at establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.
Strong command of English, and the local language as necessary, both written and verbal.
Ability to work in an environment of remote collaborators.
EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
