Lead Clinical Research Associate

About the role

The Lead CRA is an important 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. Lead CRAs work closely with the Director of Clinical Monitoring, In-house CRAs, field CRAs, Associate 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.

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.
• Monitors performance of CRAs on a continuous basis, 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 development of study-specific Clinical Monitoring Plans and training presentations as needed.
• Assists in resourcing CRAs for planned and ongoing clinical trials.
• 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.
• Ensures 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.
• Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
• Promotes a collaborative team atmosphere between CRAs.
• Participates in internal, client/sponsor, scientific, and other meetings as required.
• Performs additional duties as assigned.

Requirements

• 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 a plus.
• Excellent knowledge of clinical research, ICH GCP, regulatory, ethical, and local regulations.
• US: Permanent authorization to work in the U.S.
• EU: Adequate English.

Skills

• Proven ability to be careful, thorough, detail-oriented, and quality focused.
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time.
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.
• US: Strong command of English, both written and verbal.
• Excellent communication and interpersonal skills with customer service orientation.
• Good computer skills, with ability to use CTMS systems, clinical trial databases, and electronic data capture.
• Knowledge of Pharmacovigilance processes.
• Ability to travel.
• Professional, trustworthy, and disciplined.
• Able to manage stress and conflicts.
• Leadership attitude.
• Problem-solving skills.
• Self-starter who thrives in a collaborative, yet less structured team environment.

Working Conditions

Normal office working conditions including frequent sitting, standing, bending, twisting, and computer monitor use. Occasional lifting of weight up to 30 lbs.

Pay

North America: $110,000-$130,000 annually. The final offer will be determined within the applicable location-specific range and will depend on the candidate's confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.