Clinical Research Associate

📋 Description

• • As a Clinical Research Associate (CRA) at Alira Health, you will be an integral and highly motivated member of our global Clinical team, driving the success of clinical trials through meticulous site monitoring and expert guidance.
• • This role offers the unique opportunity to work independently while collaborating with a dedicated team, fostering innovation and initiative across different time zones and physical locations.
• • You will be responsible for conducting comprehensive site monitoring visits, including selection, initiation, ongoing monitoring, and close-out phases, ensuring strict adherence to contracted scopes of work, Alira Health Standard Operating Procedures (SOPs), and critical regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
• • Your responsibilities extend to potentially performing or liaising with Central Monitoring activities, acting as a key conduit between investigative sites and central monitoring teams to ensure data integrity and operational efficiency.
• • A significant aspect of your role will involve actively working with clinical sites to adapt strategies, drive, and meticulously track subject recruitment, aligning with project timelines and expectations to meet study objectives.
• • You will be the primary point of contact for training assigned sites on protocol specifics and study-related procedures, establishing and maintaining clear lines of communication to manage ongoing project expectations, address emerging issues, and ensure smooth study progression.
• • Evaluating the quality and integrity of practices at study sites is paramount, ensuring the proper conduct of the protocol and upholding the highest standards of clinical trial execution.
• • You will collaborate seamlessly with cross-functional teams and fellow CRAs, contributing to a unified effort to maintain exceptional standards in clinical trial conduct and data quality.
• • Ensuring the informed consent process is conducted ethically and documented accurately for every participant, in strict accordance with applicable requirements and standards, is a core duty.
• • You will exhibit unwavering dedication to upholding the privacy and confidentiality of all subjects and participants throughout the trial lifecycle.
• • Proactively escalating any quality issues or concerns according to the established Alira Health escalation pathway is crucial for maintaining compliance and mitigating risks.
• • Conducting thorough investigational product (IP) inventory and accountability checks, evaluating storage conditions, and verifying access protocols are essential tasks.
• • You will meticulously evaluate IP dispensing and administration to participants, ensuring compliance with the study protocol and leveraging your expertise in GCP, local regulations, and Alira Health procedures to guarantee proper IP labeling, relabeling, transportation, release, return, or destruction.
• • Routinely reviewing the Investigator Site File (ISF) for audit readiness, ensuring its accuracy and completeness, is a key responsibility.
• • You will reconcile the ISF with the Trial Master File (TMF), ensuring all essential documents are filed in accordance with local guidelines and regulations, maintaining a comprehensive and accessible study record.
• • Performing quality checks on regulatory documents, adhering to ALCOA+ principles, and collecting copies for TMF filing will be part of your duties.
• • Supporting audit readiness by submitting documents to the TMF, utilizing filing indexes and systems like Medidata as necessary, is critical for regulatory compliance.
• • You will support research sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm necessary approvals are obtained.
• • Developing and maintaining an in-depth knowledge of ICH GCP, ISO 14155 guidelines, and specific local regulatory requirements is essential for success in this role.
• • Verification and review of safety events (Adverse Events - AE, Serious Adverse Events - SAE, etc.), including reconciliation of concomitant medications and medical history, are vital to confirm accurate reporting in accordance with the protocol and relevant regulations.
• • Assisting in the setup and collection of site-specific ethics documents and supporting site contract negotiations will be part of your collaborative efforts.
• • Providing monthly billing information to the finance team, as required, ensures efficient financial management of the study.
• • For monitoring stand-alone projects, you will manage the study budget and act as the primary referent for the sponsor, demonstrating leadership and financial acumen.
• • Consistently preparing accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and Clinical Monitoring Plan timelines is a key deliverable, detailing site-specific concerns, follow-up actions, corrective measures, protocol deviations, enrollment progress, and safety events.
• • Ensuring the integrity of source records and case report forms through meticulous review and verification for accuracy and completeness is fundamental to data reliability.
• • Participating in internal, client/sponsor, scientific, and other relevant meetings as required, contributing your expertise and insights.
• • Completing consistent review of Case Report Form (CRF) queries, working closely with site staff and data management to resolve discrepancies and ensure data accuracy.
• • Conducting audit preparation at study sites as needed, ensuring sites are prepared for regulatory inspections.
• • Working collaboratively with other CRAs to maintain consistency across sites and promote a positive, productive team atmosphere.
• • Collaborating with all study team members for effective project execution and performing additional duties as assigned to ensure overall study success.