FSP CRA II - Alzheimer's Experience - US West

About the Role

Join a global team performing and coordinating all aspects of clinical monitoring and site management. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance, manage documentation, and ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, and applicable regulations. This role involves managing procedures from various sponsors, ensuring audit readiness, and developing collaborative relationships with investigational sites. The position is available to candidates located in the Western United States (WA, OR, CA, MT, ID, WY, UT, CO, AZ, NV, NM) and requires up to 75% domestic travel.

Responsibilities

• Monitor investigator sites using a risk-based approach, applying root-cause analysis, critical thinking, and problem-solving to identify and resolve site process failures.
• Ensure data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote monitoring.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters using approved business writing standards.
• Escalate deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Collaborate with the project team on issue resolution and findings follow-up.
• Provide trial status updates and progress reports to the Clinical Team Manager (CTM).
• Update study systems (e.g., Clinical Trial Management System, CTMS) per agreed conventions and perform QC checks on CTMS-generated reports.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client to ensure qualified site acceptability.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with protocol, regulatory, and ICH-GCP obligations.
• Ensure trial close-out and retrieval of trial materials.
• Verify that essential documents are complete and compliant with ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Assist in preparing project publications/tools and share ideas with the team.
• Perform additional study tasks as assigned by the CTM (e.g., trip report review, newsletter creation, leading CRA team calls).
• Facilitate communication between investigative sites, the client, and the PPD project team.
• Respond to company, client, and regulatory audits/inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets.
• Contribute to process improvement initiatives and other project work as required.

Requirements

• Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic/vocational qualification.
• Previous experience as a clinical research monitor (comparable to 2+ years).
• Valid driver’s license where applicable.
• In some cases, an equivalency of appropriate education, training, and/or directly related experience may be considered.

Skills

• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Excellent understanding and application of ICH-GCP, applicable regulations, and procedural documents.
• Well-developed critical thinking, root-cause analysis, and problem-solving skills.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Effective oral and written communication skills, including the ability to communicate with medical personnel.
• Strong customer focus, including good listening skills and attention to detail.
• Effective interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Ability to remain flexible and adaptable in various scenarios.
• Ability to work independently or as part of a team.
• Proficiency in Microsoft Office and ability to learn relevant software.
• Strong English language and grammar skills.
• Good presentation skills.

Environmental Conditions

• Work is performed in an office, laboratory, clinical, and/or home office environment with exposure to electrical office equipment.
• Frequent driving to site locations and domestic travel (generally 60-80%, up to 75% for this role), including extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms; personal protective equipment (e.g., eyewear, garments, gloves) required.
• Occasional exposure to fluctuating and/or extreme temperatures.
• Must comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information when required.

Pay

The estimated salary range for this position based in California is $88,600.00–$132,000.00. This position may also be eligible for a variable annual bonus based on company, team, and/or individual performance.

Benefits

• A choice of national medical, dental, and vision plans, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO), 10 paid holidays annually, and paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident, life, short-term, and long-term disability insurance.
• Retirement and savings programs, including a competitive 401(k) plan.
• Employees’ Stock Purchase Plan (ESPP) with the opportunity to purchase company stock at a discount.