Clinical Research Associate CRA

KEY RESPONSIBILITIES

• 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.
• Safeguards appropriate and timely investigator site visits.
• Collaborates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
• Aids in the development of study-specific Monitoring Plans and training presentations as required.
• Aids in the setup/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.
• Conducts 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 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.

DESIRED QUALIFICATION & EXPERIENCE

• EU: Graduation in a scientific health field
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
• Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
• 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
• 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 Languages
• Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences