The Senior Clinical Research Associate (Sr. CRA) is a key member of Alira Health's Clinical team, responsible for conducting site monitoring activities and providing leadership in the execution of clinical trials to ensure compliance, quality, and protocol adherence. This role involves close collaboration with US and EU-based clinical teams, project managers, and sponsors across time zones in a global, collaborative environment.
What You'll Do
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
- Ensures appropriate and timely investigator site visits.
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
- Assists in development of study-specific Monitoring Plans and training presentations as required.
- Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
- Provides monthly billing information to finance team as required.
- For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
- Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
- Ensures integrity of CRF data through meticulous and thorough source document review and verification.
- Performs quality control and verification of documents collected at sites for eTMF/TMF.
- Conducts investigational product accountability.
- Reviews site regulatory binder for required documents.
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
- Participates in internal, client/sponsor, scientific, and other meetings as required.
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
- Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
- Proactively identifies site issues and develops problem-solving strategies for sites.
- Conducts audit preparation at study sites as needed.
- Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
- Participates in internal, client/sponsor, scientific, and other meetings as required.
- Assists in CRA new hire training and onboarding.
- Performs CRA mentoring.
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
- Manages and resolves conflicting priorities to deliver on commitments.
- Performs additional duties as assigned.
What We're Looking For
- EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities
- EU: Graduation in a scientific health field.
- EU: Adequate English
- EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
- US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
- US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 years of clinical monitoring experience with 1 year of management experience
- US: Permanent authorization to work in the U.S.
- US: Strong command of English, both written and verbal
- 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
- 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
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
Technical Stack
- Clinical Trial Management System (CTMS)
- clinical trial databases
- electronic data capture
Team & Environment
Global team with cross-functional collaboration between US and EU teams including Director of Clinical Monitoring, Lead CRAs, in-house CRAs, Associate Director of Clinical Monitoring, CRAs, and Project Managers. Reporting structure: US-based Sr. CRAs report to the Director of Clinical Monitoring.
Benefits & Compensation
- Work in a global team dedicated to innovation and initiative
- Collaboration across physical walls and time zones
- Work driven by shared values: be courageous, be accountable, be honest, be inclusive and elevate others
Work Mode
Global role with team members in Ukraine (Sr. CRA FL in Ukraine), US, and EU. Work includes remote and onsite monitoring visits, with collaboration across time zones.
Alira Health is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
