Senior Clinical Research Associate

Kelly Science and Clinical is hiring on behalf of an unnamed CRO client for a Senior Clinical Research Associate to support regional clinical studies across the West Coast. The role performs clinical monitoring and site management, ensuring protocol and regulatory compliance, data integrity, documentation quality, and audit readiness.

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

Benefits

Remote / home office located near major cities on the West Coast

Company

Technical staffing and SOW services for science, engineering, technology

Troy, Michigan, USA

https://set.kellyservices.us/

Founded in 1946

5001-10000 employees

Qualifications

Bachelor's degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification

2+ 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

2+ years of previous on-site monitoring experience required.

Required skills

Clinical Monitoring, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Medical Terminology, Therapeutic Area Knowledge, MS Office

Experience

2+ years