Lead Clinical Research Associate
Not Disclosed•Full-TimeOn-site
location_onMayor's Walk, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States
About Alira Health
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. At Alira Health, all contributions and new ideas are explored with an open mind, and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.
About the Role
The Lead CRA is a pivotal member of the Alira Health Clinical team, providing oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. This role serves as a bridge between the Director of Clinical Monitoring, CRAs, CTCs, and Clinical Project Managers, ensuring protocol compliance and addressing site questions while assisting with study recruitment and training.
In this position, you will foster a collaborative team atmosphere while mentoring junior CRAs. You will evaluate the quality and integrity of CRA performance through metric tracking and report reviews, ensuring adherence to project scope, study plans, and timelines. As a leader, you may serve as a line manager with direct reports, accountable for annual performance reviews, career progression, and study assignments. Your day-to-day involves driving subject recruitment, resolving complex data queries, and ensuring audit readiness across Investigator Site Files and Trial Master Files.
Hiring Process
If you are being referred to this role by a connection in Alira Health, please apply using the specific referral link emailed to you.
Work location
Work model: On-site
Mayor's Walk, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States
Boston, Massachusetts
Key Responsibilities
- check_circlePerform site monitoring visits including selection, initiation, monitoring, and close-out in compliance with GCP and SOPs
- check_circleOversee Clinical Research Associates to ensure monitoring visits are conducted within timelines and quality standards
- check_circleCollaborate with cross-functional teams to resolve CRF queries and ensure data integrity
- check_circleAssist in site contract negotiation and collection of site-specific ethics documents
- check_circleTrack study metrics and escalate quality issues or trends to the Project Manager and Sponsor
- check_circleConduct investigational product inventory, accountability, and evaluate storage conditions and access protocols
- check_circleReview Investigator Site Files for audit readiness and reconcile with the Trial Master File
- check_circlePrepare accurate monitoring visit reports and communication logs detailing site concerns and protocol deviations
- check_circleManage study budgets and act as the primary referent for sponsors on stand-alone monitoring projects
- check_circleVerify and review safety events including reconciliation of concomitant medications and medical history
- check_circleParticipate in audits, bid defense meetings, and present at Investigator Meetings
- check_circleProvide CRA training, mentoring, and performance evaluations to junior team members
Requirements
- verifiedBachelor's degree in sciences, nursing, or medical field
- verified7+ years experience in clinical research or health industry
- verifiedClinical monitoring experience in pharmaceutical, biotech, medtech, or CRO industries
- verifiedExpertise in data management, site management, and monitoring
- verifiedProficiency in clinical trial software and tools
- verifiedIn-depth knowledge of ICH GCP and ISO 14155 guidelines
- verifiedStrong command of English and local language
- verifiedEU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
Nice to Have
Bachelor's degree in sciences, nursing, or medical fields.
Similar Job Opportunities
Skills, education and keywords
Skills: Good Clinical Practice, GCP, Ich Guidelines, Ich GCP, Iso 14155, Medidata, Edc, CTMS, TMF, Isf.
Education: Bachelor's degree in a relevant field (sciences, nursing, medical preferred); Bachelor of Science in Biology; Bachelor of Science in Biotechnology.
Frequently asked questions about Lead Clinical Research Associate at Alira Health
What does a Lead Clinical Research Associate at Alira Health do?expand_more
Day-to-day, the Lead Clinical Research Associate at Alira Health will perform site monitoring visits including selection, initiation, monitoring, and close-out in compliance with gcp and sops; oversee clinical research associates to ensure monitoring visits are conducted within timelines and quality standards; collaborate with cross-functional teams to resolve crf queries and ensure data integrity; and assist in site contract negotiation and collection of site-specific ethics documents.
What are the requirements for this Lead Clinical Research Associate role?expand_more
Alira Health is looking for candidates who meet the following requirements: Bachelor's degree in sciences, nursing, or medical field; 7+ years experience in clinical research or health industry; Clinical monitoring experience in pharmaceutical, biotech, medtech, or CRO industries; Expertise in data management, site management, and monitoring; Proficiency in clinical trial software and tools; and In-depth knowledge of ICH GCP and ISO 14155 guidelines.
Where is the Lead Clinical Research Associate role at Alira Health located?expand_more
Lead Clinical Research Associate at Alira Health is based in Mayor's Walk, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States. This is a on-site role.
Is this Lead Clinical Research Associate job remote, hybrid, or on-site?expand_more
Alira Health has listed this Lead Clinical Research Associate role as on-site.
How much experience is required for this Lead Clinical Research Associate role?expand_more
Lead Clinical Research Associate at Alira Health typically requires 7+ years of relevant experience at the lead level.
What skills do you need for the Lead Clinical Research Associate role at Alira Health?expand_more
Key skills for Lead Clinical Research Associate at Alira Health include Good Clinical Practice; GCP; Ich Guidelines; Ich GCP; Iso 14155; Medidata; Edc; and CTMS.
What education is required for Lead Clinical Research Associate at Alira Health?expand_more
Educational requirements for this role: Bachelor's degree in a relevant field (sciences, nursing, medical preferred); Bachelor of Science in Biology; and Bachelor of Science in Biotechnology.
What category does the Lead Clinical Research Associate role belong to?expand_more
Lead Clinical Research Associate at Alira Health is part of the scientific & qa job category on Recrutus.