Lead Clinical Research Associate

KEY RESPONSIBILITIES

• Provides guidance, oversight, and feedback to the field CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Ensures quality of data is in line with clinical standards and that the rights and safety of patients involved in studies are protected.
• Makes sure the quality of CRA performance is continuously monitored, including reviewing monitoring visit reports and conducting co-monitoring visits as needed.
• Performs CRA mentoring and oversight of CRA activities including evaluation of quality of work through co-monitoring.
• 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 developing study-specific Clinical Monitoring Plans and training presentations as needed.
• Supports CRA hiring through initial screening, phone, and video interviews of potential new employees.
• Responsible for CRA new hire training and onboarding.
• Conducts review of CRA time and expenses, as appropriate.
• Provides monthly billing information to finance team.
• Performs qualification, initiation, interim, and close-out visits both onsite and remote, 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.
• Maintains integrity of CRF data through meticulous and thorough source document review and verification.
• Conducts investigational product accountability.
• Reviews site regulatory binder for required documents, performing quality assurance of documents collected at sites for uploading to eTMF/TMF.
• 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.
• Proactively identifies site issues and develops problem-solving strategies.
• Conducts audit preparation at study sites as needed.
• Supports study team with set-up, collection of site specific ethics documents and site contract negotiation as required.
• Participates and attends bid defense meetings as required.
• Supports improvement and set up of new company processes/procedures related to monitoring activities.
• Promotes a collaborative team atmosphere between CRAs.
• Participates in internal, client/sponsor, scientific, and other meetings as required.

DESIRED QUALIFICATION & EXPERIENCE

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
• US: 4 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 years’ experience in clinical monitoring with 1 year of management experience
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
• EU: Graduation in a scientific/health field
• EU: Extensive experience in clinical monitoring, in local and international studies, multiple therapeutical areas and phases.
• Experience in clinical project management is not mandatory but is considered as a plus
• Excellent knowledge of clinical research, ICH GCP, regulatory, ethical and local regulations

CERTIFICATIONS

• US: Permanent authorization to work in the U.S.
• EU: Adequate English