The Clinical Research Associate is responsible for the following:

• Act as the primary site contact and site manager throughout all phases of a

clinical research study, taking overall responsibility of allocated sites

Key Accountabilities:

Site Management Responsibilities

Supporting Activitiesmay include but not limited to the following

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial 

• Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents 

• Gains an in-depth understanding of the study protocol and related procedures 

• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready 

• Participates and provides inputs on site selection and validation activities 

• Performs remote and on-site monitoring & oversight activities using various tools to ensure: 

• Data generated at site are complete, accurate and unbiased 

• Subjects’ right, safety and well-being are protected 

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner 

• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out 

• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance 

• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager 

• Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines 

Team Development and Support

• Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required 

• Supports and/or leads audits/inspection activities as needed 

• Performs co-monitoring visits where appropriate 

Skills:

• Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively 

• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines 

• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines 

• Hands on knowledge of Good Documentation Practices 

• Proven skills in Site Management including management of site performance and patient recruitment 

• Demonstrated high level of monitoring skill with independent professional judgement 

• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices 

• Ability to understand and analyze data/metrics and act appropriately 

• Capable of managing complex issues, working solution-oriented manner 

• Performs root cause analysis and implements preventative and corrective action 

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills 

• Demonstrated high level of monitoring skill with independent professional judgement 

• Able to work highly independently across multiple protocols, sites, and therapy areas 

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. 

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. 

• Demonstrates commitment to Customer focus 

• Works with high quality and compliance mindset 

• Positive mindset, growth mindset, capable of working independently and being self-driven 

• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices 

• Ability to travel domestically and internationally approximately 65%-75% of working time 

• Expected travelling ~2-3 days/week 

• Current driver’s license required 

Knowledge and Experience:

• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO 
• Oncology monitoring experience required

Education:

• Bachelor’s degree preferred with a strong emphasis in science and /or biology 

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