FSP CRA II - Alzheimer's Experience - US West

About the Role

Join a global team that has supported the top 50 pharmaceutical companies and over 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As a Clinical Research Associate (Level II), you’ll perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (e.g., FSO, FSP, Government) and ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. This role 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

• Monitors investigator sites using a risk-based approach, applying root-cause analysis (RCA), critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions.
• Ensures data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote monitoring activities.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management and follows through to resolution.
• Maintains regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan and participates in the investigator payment process.
• Collaborates with the project team on issue resolution and investigates/follows up on findings as applicable.
• Provides trial status tracking and progress updates to the Clinical Team Manager (CTM).
• Ensures study systems (e.g., Clinical Trial Management System, CTMS) are updated per agreed conventions and performs QC checks of CTMS-generated reports.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client to ensure qualified site acceptability.
• Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol, regulatory, and ICH-GCP obligations, making recommendations where warranted.
• Ensures trial close-out and retrieval of trial materials, including completion of required essential documents per ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Contributes to project publications/tools and shares ideas/suggestions with team members.
• Performs additional study tasks as assigned by the CTM (e.g., trip report review, newsletter creation, leading CRA team calls).
• Facilitates communication between investigative sites, the client, and the PPD project team through written, oral, and/or electronic contacts.
• Responds to company, client, and regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks (e.g., expense reports, timesheets) in a timely manner.
• Contributes 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 comparable to 2+ years as a clinical research monitor.
• Valid driver’s license where applicable.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient.

Skills

• Effective clinical monitoring skills and 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, including root-cause analysis and problem-solving.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Effective oral and written communication skills, with the ability to communicate with medical personnel.
• Strong customer focus, including good listening skills, attention to detail, and the ability to perceive underlying issues.
• Effective interpersonal skills and strong attention to detail.
• Strong organizational and time management skills, with the ability to remain flexible and adaptable in various scenarios.
• Ability to work in a team or independently as required.
• Proficiency in Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills, along with presentation skills.

Environmental Conditions

• Work is performed in an office, laboratory, clinical, and/or home office environment with exposure to electrical office equipment.
• Frequent travel to site locations, 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.
• Rare exposure to fluctuating and/or extreme temperatures.
• Must comply with specific sponsor/client/site requirements, which may include disclosure of vaccination status or other personal information.

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 results in accordance with company policy.

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 in accordance with company policy.
• Retirement and savings programs, including a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering the opportunity to purchase company stock at a discount.