Clinical Research Associate I (CRA I) - Oncology

General Description:

The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country.

The CRA is responsible for delivering data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.

Essential Functions of the Job:

• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require

• Conducts co-monitoring visits, if required

• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)

• Attends onboarding, disease indication and project specific training and general CRA training as required

• Documents monitoring activities appropriately following ICH-GCP and BeOne standards

• Conducts Quality Oversight Visits (QOV), as requested

• Completes monitoring visit/ QOV reports timely

• Assists with investigator/site identification

• Assists site to prepare Ethics Committee submissions

• Facilitates clinical trial site contract and budget negotiation

• Manages site queries and communications

• Assists in managing clinical trials, if required

• Establishes regular lines of communication with sites and COMs

• Provides protocol and related study training to assigned sites

• Evaluates the quality and integrity of site practices – escalating quality issues as appropriate

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

• Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed

• Performs additional task as assigned

Computer Skills:

• Efficient in Microsoft Word, Excel, PowerPoint, OneNote, and Outlook

• Familiar with industry EMR, CTMS, Site File Management, and data management systems

Other Qualifications:

• At least 2 years of Clinical Research Coordinator experience in Oncology

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• Excellent communication and interpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Fluent in English (writing and speaking)

Additional Experience:

• Early Phase Preferred

• Hematology and Solid Tumor Experience Preferred

Travel:

• Up to 70% travel- multi regional

Education Required:

• Bachelor’s degree or above in life sciences, pharmacy, nursing or medical.

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.