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Job Description Summary
The Lead CRA is an important member of the Alira Health Clinical team. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with the Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.Job Description
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.
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 or trends appropriately per the escalation pathway.
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols. Confirms IP has been dispensed and 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.
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.
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.
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.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
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.
Provides monthly billing information to the finance and project management team, as needed.
Performs CRA training and mentoring to more junior level CRAs.
May co-monitor and perform Evaluation Visits for more junior level CRAs.
Provides guidance, oversight, and feedback to the study team to ensure adherence to project scope, study plans, timelines, and budget requirements.
Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan or adjusted as necessary to align with the project requirements. Monitors site and CRA performance to maintain SDV rates within study goal range, directing CRAs to perform additional visits when thresholds are not met.
Oversees CRAs in the execution of ongoing site management activities, including reviewing Electronic Data Capture (EDC) queries, resolving follow-up items and responding to site staff inquiries in a timely manner.
Can serve as a line manager with direct reports, with accountability for CRA annual performance reviews, continued career progression, Key Performance Indicators (KPIs) and study/site assignments.
Ensure CRAs are working with sites to drive, track and report on subject recruitment in line with project needs and expectations.
Provide protocol and study related training to assigned CRA and establish regular lines of communication to manage ongoing project expectations and issues.
Evaluate the quality and integrity of CRA performance through monitoring visit report review. Review will ensure evidence of adequate CRA oversight and site management per the Clinical Monitoring Plan (CMP), Alira Health SOPs and ICH GCP. Specifically, adequate oversight of IP and accountability, routine review of ISF and audit readiness, clear and adequate reporting of protocol deviations, ensuring resolve of follow-up items in a timely manner and study compliance by the site staff and PI. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.
Evaluate the quality and integrity of CRA performance through metric tracking. Specifically, tracking EDC query resolution and follow-up issue duration. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.
Maintains oversight and accountability of monitoring visit reports, ensuring CRAs submit the draft, and the report is finalized within the Alira Health SOP and CMP timelines. Responsible for tracking study specific metrics, sharing with the Project Manager and escalating to the Director of Clinical Monitoring as needed.
Consistently reviews monitoring visit reports within the Alira Health SOP and CMP timelines.
Works closely with Project Managers, CRAs and Data Management to resolve CRF queries on discrepant data.
Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
Prepares for, attends and presents during Investigator Meetings.
Conducts project specific CRA meetings and trainings.
May be mentored and assigned Project Management, or other operational tasks, under the supervision of an experienced team member.
Assists in resourcing planning for upcoming and ongoing clinical trials.
Can support hiring potential new employees.
Can be responsible for CRA new hire training and onboarding.
Can conduct review of CRA timesheet reporting.
May participate and present in bid defense meetings.
May participate in audits and associated meetings, including preparation at study sites as needed.
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).
Preferred 7+ years’ experience in the clinical research or health industry fields. Clinical monitoring experience required in the pharmaceutical, biotech, medtech or CRO industries. People and study management experience required.
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools.
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.
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.
Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.
Skilled at establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.
Experience in people and study management.
Strong command of English, and the local language as necessary, both written and verbal.
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.
Compensation: $130,000 - 155,000 commensurate with experience
Languages
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type
Regular