Senior Clinical Research Associate

• CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.

• CRA performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/onco-hematology clinical trials within the assigned country/region.

• May be assigned to CRA activities or start-up activities, depending on experience and project needs.

• CRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained.

• CRA identifies gaps and areas for improvement and propose CAPA.

• CRA supports start-up and provides local expertise.

  expertise.

Essential Functions of the job:

• Complete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties.

• Gain experience in BeOne and study procedures by working with experienced clinical staff.

• Perform site selection and evaluation, supporting initial list of sites and recruitment targets.

• Provide protocol and related study training to assigned sites.

• Conduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs.

• Conduct co-monitoring visits, if required.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation, in accordance with ICH-GCP, BeOne standards and SOPs.

• Manage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.

• Ensure inspection readiness of the study and sites

• Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations.

• Collaborate with Country and Regional Clinical Study Managers and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)

• Facilitate Study Compliance Visits (SCVs), site audits and/or inspections, as required

• Evaluate the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.

• Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.

• Mentor junior staff (Associate CRA and CRA).

• Act as the escalation point person for CRA(s) with site-related issues and concerns. 

• May review visits reports, following-up on issue resolution and communicating with the Country/Regional Clinical Study Manager on significant risk identified and action proposed. 

• May serve as subject matter expert for clinical operations, country regulations and monitoring-related activities. 

Supervisory Responsibilities:  

• Mentor/Buddy for junior CRAs. 

• Acts as the escalation point person for CRAs with site-related issues and concerns. 

• May serve as subject matter expert for clinical operations and CRA-related activities;

Education Required:

• BS in a scientific or healthcare discipline preferred and at least 3 - 5 years of monitoring experience.

• Experience in oncology/onco-hematology global trials preferred

Other Qualifications:    

• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines.

• At least 3 - 5 years of (CRA)  monitoring experience in the pharmaceutical or CRO industry. An equivalent combination of education, training, and experience may be considered.

• Experience in oncology/onco-hematology trials preferred

• Excellent communication and interpersonal skills

• Ability to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders as applicable

• Excellent organizational and problem-solving skills and ability to prioritize and multitask

• Effective time management skills

• Written and verbal communication skills, including a good command of the English language and Italian

Computer Skills:

Efficient in Microsoft Word, Excel, PowerPoint, Outlook, and use of a laptop computer and iPhone.

Travel:  up to 75-80%