Clinical Research Associate

About the role

We are looking for CRAs located in the East Coast and/or Chicago area.

Responsibilities

• 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.
• Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.
• 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.
• 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.
• Aids 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.
• 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.

Requirements

• 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.
• Able to work in an environment of remote collaborators.
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.

Compensation

USD $85,000 - 125,000 commensurate with experience