2+ years of direct site monitoring experience in biotech, pharma, or CRO
Bachelor's degree in science or biology
Fluent in local languages and English, with strong communication skills
Good understanding of clinical research and GCP/ICH guidelines
Proven site management skills, including patient recruitment and performance management
Strong IT skills, including proficiency in MS Office and clinical applications
Ability to analyze data and manage complex issues effectively
Responsibilities
Act as primary site contact and manager throughout clinical study phases
Develop and maintain strong relationships with study sites
Perform site management and monitoring activities in compliance with regulations
Conduct site visits and ensure accurate documentation of findings
Communicate effectively with investigators and site staff regarding study conduct
Identify and resolve site performance and compliance issues
Manage documentation in Clinical Trial Management Systems and other platforms
Benefits
Opportunity for remote work
Professional development through mentorship and knowledge sharing
Involvement in audits and inspections
Dynamic work environment with diverse protocols and therapy areas
Travel opportunities domestically and internationally (65%-75% of time)
Full Job Description
Job Summary:
The Clinical Research Associate II will 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
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
Compliance with Parexel Standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements
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 biotech/pharma/CRO
Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs.
Education:
Bachelor's degree with a strong emphasis in science and /or biology
