Clinical Operations Site Lead & CRA Coach

Worldwide Clinical Trials; Roma; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Worldwide Clinical Trials is seeking a Clinical Operations Site Management professional to drive CRA/IHCRA onboarding, training and mentoring on-site within a global CRO setting. You will ensure consistent onboarding of permanent and contract CRAs/IHCRAs and manage performance and quality across projects.

You will collaborate with leadership to optimize visit types, approvals and billing processes, while maintaining regulatory compliance and process standards in a dynamic, team-oriented

Competenze

• Ability to understand multiple study protocols.
• Excellent oral and written communication.
• Strong planning and organizational skills.
• Good interpersonal skills.
• Experienced problem solving/decision making skills.
• Good attention to detail.
• Understanding of clinical research principles and process, data collection and editing skills.
• Ability to navigate in EDC software (InForm, Medidata, etc.)
• Strong knowledge of FDA regulations, ICH Guidelines and HIPAA.
• Understanding of standard operating procedures.
• Knowledge of therapeutic areas.
• Knowledge of Word, Excel and Outlook

Mansioni

• Interview and select CRA/IHCRA candidates and ensure onboarding of permanent and contract CRAs/IHCRAs.
• Ensure CRAs are properly and timely trained to perform all types of visits and other billable monitoring activities.
• Provide on-site mentoring for CRAs through observation or site assessment visits.
• Establish regular communication and 1:1 calls with CRAs/IHCRAs to review quality metrics.
• Act as point of escalation for CRA/IHCRA performance issues on projects.
• Review Time Cards, including review and approval of hours billed by contractors.
• Review the accuracy of Sciforma assignments and workload.
• Conduct performance appraisals, rewarding and disciplining employees, addressing employee relations issues and resolving problems.
• Write and conduct CAPAs when necessary; Support Directors of Clinical Operations.
• Approve CRA/IHCRA PTO requests.
• Review and approve CRAs/IHCRAs' non-billable expenses

Conoscenze

Protocol understanding

Communication skills

Planning skills

Interpersonal skills

Problem solving

Attention to detail

Clinical research principles

EDC software

FDA regulations

ICH Guidelines

HIPAA

SOPs knowledge

Therapeutic knowledge

MS Office

Formazione

Life sciences degree

Strumenti

InForm

Medidata

Descrizione del lavoro

Worldwide Clinical Trials is seeking a Clinical Operations Site Management professional to drive CRA/IHCRA onboarding, training and mentoring on-site within a global CRO setting. You will ensure consistent onboarding of permanent and contract CRAs/IHCRAs and manage performance and quality across projects.

You will collaborate with leadership to optimize visit types, approvals and billing processes, while maintaining regulatory compliance and process standards in a dynamic, team-oriented