Clinical Research Associate

About the role

Kelly Science and Clinical is hiring on behalf of a large CRO client to support a six‑month project with potential extension. The role supports regional studies at sites across the West Coast, requiring at least two years of experience monitoring complex therapeutic studies, preferably with large CRO experience. The CRA I performs and coordinates all aspects of clinical monitoring and site management, conducts remote or on‑site visits to assess protocol and regulatory compliance, manages documentation, and ensures trials follow approved protocols, ICH‑GCP, regulations, and SOPs. The position is remote/home‑office based near major cities in CA, NV, CO, UT, or AZ, with regional West Coast travel up to 80% as needed.

Responsibilities

• Monitor investigator sites using a risk‑based monitoring approach; apply root cause analysis, critical thinking, and problem‑solving to identify site process failures and implement CAPA.
• Ensure data accuracy through Source Document Review (SDR), Source Document Verification (SDV), and Case Report Form (CRF) review during on‑site and remote monitoring.
• Assess investigational products via physical inventory checks and records reviews.
• Document observations in reports and follow‑up letters using professional business writing standards.
• Escalate observed deficiencies to clinical management expeditiously and follow issues to resolution.
• Maintain regular contact with investigative sites between visits to confirm protocol adherence, track issue resolution, and ensure timely data entry.
• Conduct monitoring tasks per the approved monitoring plan, assist with investigator payment process, and participate in investigator meetings as needed.
• Provide trial status tracking and progress update reports to the Clinical Team Manager; update study systems (e.g., CTMS) per study conventions and perform QC checks on CTMS‑generated reports.
• Collaborate with the client to identify qualified investigators, initiate clinical trial sites per procedures, and make recommendations.
• Oversee trial close‑out procedures and retrieval of trial materials.
• Ensure required essential documents are complete, accurate, and filed per ICH‑GCP and applicable regulations; conduct on‑site file reviews.
• Contribute to the project team by assisting in preparation of project publications and tools, sharing actionable ideas, and leading CRA team calls.
• Facilitate effective communication between investigative sites, the client, and the project team via written, oral, and electronic channels.
• Respond to company, client, and regulatory requirements, audits, and inspections.
• Complete administrative tasks such as expense reports and timesheets timely.
• Contribute to project initiatives and process improvement efforts as required.

Requirements

• Bachelor’s degree in a life‑science‑related field, Registered Nurse (RN) certification, or equivalent academic/vocational qualification.
• 2+ years of experience as a clinical research monitor or equivalent experience demonstrating the necessary knowledge, skills, and abilities.
• Prior monitoring experience in complex therapeutic areas; large CRO experience preferred.
• Valid driver’s license.

Skills

• Effective clinical monitoring skills across full study lifecycles.
• Demonstrated understanding of medical/therapeutic area knowledge and terminology.
• Strong understanding and practical application of ICH‑GCP guidelines, applicable regulations, and procedural documents.
• Well‑developed critical thinking skills, including root cause analysis and proactive problem‑solving.
• Ability to apply Risk‑Based Monitoring concepts and processes.
• Clear oral and written communication skills; ability to interact effectively with medical personnel and site staff.
• Strong customer focus with active listening, high attention to detail, and ability to address underlying customer needs.
• Excellent interpersonal, organizational, and time‑management skills.
• Ability to remain flexible and adaptable across a range of study scenarios.
• Proven ability to work effectively both independently and as part of a collaborative team.
• Computer proficiency, including Microsoft Office, with ability to quickly learn EDC and CTMS platforms.
• Strong English language and grammar skills.
• Effective presentation and communication skills.

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, legal plan, and short‑term disability.
• Retirement savings plan, service bonus and holiday pay plans (up to eight paid holidays per benefit year).
• Transit spending account.
• Paid sick leave under applicable state or local plan.

Pay

$55.86 – $62.07 per hour door‑to‑door (limited benefits options available).