Clinical Research Associate

Benefits

Qualifications

• •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
• •Quality focused; Proven ability to be careful, thorough, and detail-oriented
• •Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• •Able to manage priorities, organize time and solve problems
• •Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• •Ability to travel
• •Ability to manage stress
• •Professional, trustworthy and disciplined
• •Ability to problem-solve unstructured or ambiguous challenges
• •Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
• •Excellent communication and interpersonal skills with customer service orientation
• •Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
• •Self-starter who thrives in a collaborative, yet less structured team environment
• •Knowledge of clinical research, ICH GCP and local regulations
• •Knowledge of Regulatory and Ethical requirements
• •EU: Adequate English
• •24 more items(s)

Responsibilities

• •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, in-house CRAs, Associate 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
• •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
• •30 more items(s)