Sr CRA (PPV)

Job Description

Job Description

Job Title: Senior Clinical Research Associate (Alzheimers Focus)

Job Description

The Senior Clinical Research Associate will oversee and monitor clinical trials focused on Alzheimers disease within the Central Nervous System (CNS) domain. This hybrid role is primarily home-based, with regular on-site visits to assigned research sites. The Senior CRA ensures that studies comply with Good Clinical Practices (GCP), local and international regulations, and Standard Operating Procedures (SOPs). The role includes managing site qualification, initiation, interim monitoring, site management, and close-out visits, while ensuring high-quality, timely data submission and appropriate reporting and follow-up of safety events.

Responsibilities

• Oversee site qualification, initiation, interim monitoring, site management, and study close-out visits in accordance with GCP, regulatory requirements, and SOPs.
• Write comprehensive site visit trip reports that accurately document activities, findings, and follow-up actions.
• Compile, review, and ensure completeness of regulatory documents and ethics submission documentation, including IRB/IEC approvals and informed consent forms.
• Coordinate the shipment and receipt of study materials, including case report forms (CRFs), study manuals, and related documentation to and from study sites.
• Document site visit findings clearly and thoroughly through written reports and follow-up correspondence.
• Review study subject safety information and confirm that informed consent documentation is complete, accurate, and compliant.
• Conduct detailed source document verification to ensure protocol compliance, patient safety, and data accuracy and integrity.
• Review CRFs using paper or electronic data capture systems and support sites in resolving data queries in a timely manner.
• Maintain regular, proactive communication with study site staff to support study progress, address issues, and ensure adherence to timelines and procedures.
• Monitor and track site performance, identifying issues and implementing corrective actions in collaboration with study teams as needed.
• Ensure timely submission of data from study sites and appropriate documentation of safety events and protocol deviations.
• Perform other related duties as assigned to support successful execution of Alzheimers and CNS clinical trials.

Essential Skills

• Bachelors degree or a two-year nursing degree.
• Minimum of 5 years of field monitoring experience as a Clinical Research Associate.
• Experience in Central Nervous System (CNS) research, specifically Alzheimers disease.
• Strong understanding of clinical research processes, site monitoring, and clinical monitoring activities.
• Proficiency in Good Clinical Practice (GCP) guidelines and their application in clinical trial conduct.
• Familiarity with Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
• Ability and willingness to travel regularly for on-site monitoring visits.
• Proficiency in reviewing and verifying source documents and case report forms using paper or electronic data capture systems.
• Strong written communication skills for preparing comprehensive site visit trip reports and documentation.
• Ability to maintain effective, ongoing communication with research sites and study teams.

Additional Skills & Qualifications

• Prior experience with Alzheimers disease clinical trials is preferred.
• Experience working with small contract research organizations (CROs) or similar environments.
• Demonstrated ability to manage multiple research sites and competing priorities.
• Comfort working with electronic data capture systems and clinical trial documentation tools.
• Motivation to contribute to Alzheimers research with an immediate opportunity to support active, billable trial work.

Work Environment

This position is 100% home-based, supporting approximately nine research sites located in the western region. The role requires regular travel for on-site visits, typically 810 days per month, to conduct monitoring and site management activities. The work involves extensive use of electronic systems for data review, documentation, and communication, combined with on-site interaction with investigators and site staff. The environment offers the opportunity to work on Alzheimers clinical trials with a smaller CRO-type setting, providing immediate engagement in active study work and close collaboration with site teams.

This is a Contract position based out of Santa Clara, CA.

The pay range for this position is $90.00 - $96.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Oct 16, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.