Note: The job is a remote job and is open to candidates in USA. Kelly Science and Clinical is hiring on behalf of an unnamed large CRO client for a six-month CRA monitoring project with potential for extension. The CRA II conducts and coordinates clinical site monitoring and management, ensuring protocol and regulatory compliance, data integrity, documentation, and audit readiness across assigned studies.
Responsibilities
- Site Monitoring & Compliance: Monitors investigator sites using a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions (CAPA)
- Data Integrity: Ensures data accuracy through Source Document Review (SDR), Source Document Verification (SDV), and Case Report Form (CRF) review during on-site and remote monitoring visits
- IP Management: Assesses investigational products through physical inventory checks and records reviews
- Documentation & Reporting: Documents observations in reports and follow-up letters in a timely manner using professional business writing standards
- Issue Escalation: Escalates observed deficiencies to clinical management expeditiously and follows all issues through to resolution
- Site Relations & Communication: Maintains regular contact with investigative sites between visits to confirm protocol compliance, track issue resolution, and ensure timely data entry. Facilitates effective communication between sites, client management, and the project team
- Trial Execution: Conducts monitoring tasks in accordance with approved monitoring plans, assists with the investigator payment process, and participates in investigator meetings as needed
- Site Selection & Initiation: Collaborates with the client team to identify qualified investigators, initiates clinical trial sites according to relevant procedures, and makes recommendations as warranted
- Study Close-Out: Oversees trial close-out procedures and the retrieval of trial materials
- Regulatory & Essential Documents: Ensures required essential documents are complete, accurate, and filed according to ICH-GCP guidelines and applicable regulations. Conducts on-site file reviews per project specifications
- Team Contribution & Mentorship: Mentors new team members, assists in preparing project tools (e.g., informed consents, CRF guidelines, monitoring plans), and provides project-specific training to the clinical team as needed
- Process Improvement: Identifies opportunities for process improvement and shares actionable solutions with management
- Cross-Functional Support: Performs additional tasks as assigned by the Clinical Team Manager (CTM) or Clinical Manager of CRAs (CM-CRA), such as trip report reviews, newsletter creation, and leading CRA team calls
- Tracking & Systems: Provides trial status updates and progress reports to the CTM. Updates study management systems (e.g., CTMS) per agreed conventions and performs QC checks on CTMS reports as required
- Audits & Quality Assurance: Responds to company, client, and regulatory body requirements, audits, and inspections. Ensures audit readiness across assigned sites
- Administrative: Completes administrative tasks, including expense reports and timesheets, in a timely manner
Skills
- Ideal candidates have monitored complex therapeutic studies for CROs in the past
- Can work independently with minimal onboarding
- Bachelor's degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification
- 3+ years of previous on-site monitoring experience required
- Prior experience working within a large CRO is required
- Previous CRA contracting experience required
- Valid driver's license
- Strong clinical monitoring skills across full study lifecycles
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- In-depth understanding and practical application of ICH-GCP, applicable global regulations, and procedural documents
- Advanced critical thinking, root cause analysis, and problem-solving abilities
- Demonstrated proficiency with Risk-Based Monitoring (RBM) concepts and tools
- Strong written and oral communication skills, with the ability to interact professionally with medical personnel and site staff
- Excellent customer service skills, active listening abilities, and strong attention to detail
- Strong organizational, interpersonal, and time-management skills
- Ability to remain flexible and adaptable in dynamic environments
- Proven ability to work effectively both independently and within a cross-functional team
- Proficiency in computer applications, including MS Office, EDC, and CTMS platforms
- Strong English language and grammar skills
- Confident presentation and facilitation skills
Company Overview