Sr CRA II

Kelly Services-Portugal; Henderson (NV); On-site; USD 80,000 - 89,000; Full time

Job summary

Kelly Science and Clinical is seeking a Sr Clinical Research Associate II to support regional studies on the West Coast. The role requires monitoring complex therapeutic studies, remote or site visits, and ensuring ICH-GCP compliance across multiple sites with 2-3 studies and 10-12 sites.

The position offers a 6-month full-time contract with potential to extend or convert to permanent, with travel up to 80% (driving and flying) to West region sites; strong independence and good collaboration

Qualifications

• Bachelor's degree in life sciences or RN certification.
• 3+ years of on-site monitoring experience.
• Experience in a large CRO.
• CRA contracting experience.
• Valid driver's license.

Responsibilities

• Monitor investigator sites using a risk-based approach and CAPA where needed.
• Perform SDR/SDV and CRF data verification during visits.
• Manage regulatory documents and ensure audit readiness.
• Mentor new CRA team members and support project tools.
• Collaborate with clients and sites to ensure protocol compliance.

Skills

Complex therapeutic monitoring

On-site monitoring

ICH-GCP knowledge

CRO monitoring experience

Project/task support

Documentation skills

Communication skills

Travel readiness 80%

Education

Bachelor's degree in life sciences

RN certification

Tools

MS Office

CTMS

EDC

Job description

Sr Clinical Research Associate II

• Location: West Coast located near major cities in CA, NV, CO, UT, and AZ
• Travel: Regionally aligned for West Coast Travel up to 80% if needed
• Contract / Length: Full time, 6 months with potential to extend or convert to permanent.
• Pay: W-2 hourly between $58.00 - $64.90 an hour/door to door (limited benefit options)
• Must have experience: Complex therapeutic monitoring experience (i.e., oncology, neurology, CAR-T, Rare Dease); Contract or project support experience; Large CRO monitoring experience.

Kelly Science and Clinical is hiring on behalf of one of our large CRO clients to support a six-month project with the potential for future extension. We are seeking experienced CRA monitors to support regional studies at sites across the West Coast. Ideal candidates have monitored complex therapeutic studies for CROs in the past and can work independently with minimal onboarding. The average workload consists of 2-3 studies and 10-12 sites, though this may fluctuate based on project needs. The position requires flexibility to travel up to 80% (both driving and flying) to sites within the West region.

The CRA II performs and coordinates all aspects of clinical monitoring and site management. This role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation across various monitoring environments (e.g., FSO, FSP, Government). As a site processes specialist, the CRA II ensures trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects’ rights, well-being, and data reliability while ensuring audit readiness. The CRA II develops collaborative relationships with investigational sites and client personnel and may assist Project Managers or Clinical Team Managers with project tasks or mentoring junior team members. Detailed tasks and responsibilities are outlined in the project task matrix.

Essential Functions

• 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.

Education and Experience

• Bachelors 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.

Knowledge, Skills, and Abilities

• 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.